Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-04 @ 9:35 AM
Study NCT ID:
NCT01672294
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2012-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karen.steinhauser@va.gov', 'phone': '9196682148', 'title': 'Karen Steinhauser, PhD', 'organization': 'VA HSRD Durham VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During time of study participation, 8 weeks per participant. Adverse events were collected both systematically, by asking of events at each time point, and non-systematically.', 'eventGroups': [{'id': 'EG000', 'title': 'Caregiver Outlook - Caregiver', 'description': 'Intervention: Three facilitator-led sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy.', 'otherNumAtRisk': 71, 'otherNumAffected': 4, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Caregiver Outlook - Patient', 'description': 'Patients of the caregivers in the Outlook Intervention arm.', 'otherNumAtRisk': 71, 'otherNumAffected': 7, 'seriousNumAtRisk': 71, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'Relaxation Meditation - Caregiver', 'description': 'Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.', 'otherNumAtRisk': 72, 'otherNumAffected': 4, 'seriousNumAtRisk': 72, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Relaxation Meditation - Patient', 'description': 'Patients of the caregivers in the Attention Control arm.', 'otherNumAtRisk': 72, 'otherNumAffected': 11, 'seriousNumAtRisk': 72, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular/blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple/general', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastro-Intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasm-death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Caregiver Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregiver Outlook - Caregiver', 'description': 'Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).'}, {'id': 'OG001', 'title': 'Relaxation Meditation - Caregiver', 'description': 'Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': '5 week follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '4.9', 'groupId': 'OG001'}]}]}, {'title': '8 week follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.511', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5376', 'ciLowerLimit': '-1.0776', 'ciUpperLimit': '2.1528', 'pValueComment': 'Between Outlook Intervention and Attention Control caregivers at 5 weeks', 'groupDescription': 'Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6348', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4275', 'ciLowerLimit': '-1.3505', 'ciUpperLimit': '2.2055', 'pValueComment': 'Between Outlook Intervention and Attention Control caregivers at 8 weeks', 'groupDescription': 'Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': 'Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparing Caregiver anxiety levels between the Outlook and the Relaxation meditation arm. Differences in numbers analyzed versus group totals due to missing data.'}, {'type': 'SECONDARY', 'title': 'Spirituality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregiver Outlook - Caregiver', 'description': 'Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).'}, {'id': 'OG001', 'title': 'Relaxation Meditation - Caregiver', 'description': 'Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.4', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '37.3', 'spread': '7.2', 'groupId': 'OG001'}]}]}, {'title': '5 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.1', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '37.3', 'spread': '7.0', 'groupId': 'OG001'}]}]}, {'title': '8 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.3', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5225', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6836', 'ciLowerLimit': '-1.4278', 'ciUpperLimit': '2.7950', 'groupDescription': 'Comparison at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1972', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2764', 'ciLowerLimit': '-0.6728', 'ciUpperLimit': '3.2257', 'groupDescription': 'Comparison at 8 weeks. Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': 'Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale. The 12-item measure assess spiritual well-being: faith, meaning, and purpose. Individual items use a 5 point likert scale (0-4). The scale minimum score is 0 (negative well being) and maximum is 48 (positive well being).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparing spiritual well being levels between the Outlook and the Relaxation meditation arms, Caregivers only.'}, {'type': 'SECONDARY', 'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregiver Outlook - Caregiver', 'description': 'Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).'}, {'id': 'OG001', 'title': 'Relaxation Meditation - Caregiver', 'description': 'Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.2', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': '5 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '6.4', 'groupId': 'OG001'}]}]}, {'title': '7 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.3332', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9358', 'ciLowerLimit': '-0.9726', 'ciUpperLimit': '2.8443', 'groupDescription': 'Between Outlook Intervention caregivers and active control caregivers at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3842', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6929', 'ciLowerLimit': '-0.8783', 'ciUpperLimit': '2.2642', 'pValueComment': 'Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks', 'groupDescription': 'Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note - Missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': 'Centers for Epidemiologic Study of Depression short form (CES-D) is a 10-item measure of depression. Items are rated on a 4 point Likert scale (0-3) with total scores ranging from 0 to 30. Higher scores indicate greater depressive symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary and secondary results are comparing caregiver scores in the two arms, not patient arms.'}, {'type': 'SECONDARY', 'title': 'Patient Days of VA Hospital Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregiver Outlook - Patient', 'description': 'Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).'}, {'id': 'OG001', 'title': 'Relaxation Meditation - Patient', 'description': 'Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8748', 'groupIds': ['OG000', 'OG001'], 'paramType': 'expected change in difference in logs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0593', 'ciLowerLimit': '-0.6784', 'ciUpperLimit': '0.797', 'estimateComment': 'The expected change in the difference of the logs of expected Days in VA inpatient care or ED.', 'statisticalMethod': 'Standard negative binomial with offset', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'In the 6 months after randomization', 'description': 'The number of days that a patient used either the VA emergency department (ED) or was an inpatient at a VA hospital in the 6 months following randomization. Inclusion of non-VA utilization was made unpractical due to the long delay in filing for non VA reimbursement (up to 2 years). The original variable was Day AT home, defined to be 180 days minus the days in ED or inpatient hospital. This was changed to days of use due to distribution/modeling considerations.', 'unitOfMeasure': 'Days in VA hospital or ER', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Caregiver Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregiver Outlook - Caregiver', 'description': 'Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).'}, {'id': 'OG001', 'title': 'Relaxation Meditation - Caregiver', 'description': 'Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': '5 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': '8 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7687', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01777', 'ciLowerLimit': '-0.1372', 'ciUpperLimit': '0.1017', 'pValueComment': 'Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 5 weeks', 'groupDescription': 'Between Outlook Intervention caregivers and active control caregivers at 5 weeks.\n\nNote- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9863', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00087', 'ciLowerLimit': '-0.1003', 'ciUpperLimit': '0.09861', 'pValueComment': 'Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks', 'groupDescription': 'Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': "Caregiver Reaction Assessment (CRA). The Caregiver Reaction Assessment is a 24-item multidimensional instrument designed to measure a caregiver's reactions to caregiving for family members with a variety of chronic illnesses. The esteem subscale has 7 items with a 5 level Likert scale: 1=Strongly Disagree to 5=Strongly Agree. The score is the average of the 7 items ranging from a low score of 1 associated with negative reactions and high score of 5 with positive reactions.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparing Caregiver reaction assessment scores between the Outlook Intervention and the Relaxation Meditation arm.Differences in numbers analyzed versus group totals due to missing data.'}, {'type': 'SECONDARY', 'title': 'Caregiver Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregiver Outlook - Caregiver', 'description': 'Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).'}, {'id': 'OG001', 'title': 'Relaxation Meditation - Caregiver', 'description': 'Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '5 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '8 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9221', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01166', 'ciLowerLimit': '-0.2475', 'ciUpperLimit': '0.2241', 'groupDescription': 'At 5 weeks - Completion subscale', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3249', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1154', 'ciLowerLimit': '-0.3466', 'ciUpperLimit': '0.1158', 'pValueComment': 'Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks', 'groupDescription': 'Comparison at 8 week time point Note- Missing first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 week.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': 'Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 3-item Life Completion subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparing life completion scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Differences in numbers analyzed versus group totals due to missing data.'}, {'type': 'SECONDARY', 'title': 'Prolonged Grief - Number of Participants With Anticipatory Grief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregiver Outlook - Caregiver', 'description': 'Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).'}, {'id': 'OG001', 'title': 'Relaxation Meditation - Caregiver', 'description': 'Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '5 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '8 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': 'The Prolong Grief Disorder scale is a clinically-based diagnosis determination scale modified for this study. The components/requirements that were dropped were a) diagnosis should not be made until at least 6 months since death, and b) the disturbance is not better accounted for major depressive disorder, generalized anxiety disorder or post traumatic stress disorder. The outcome was a dichotomized variable with 1 indicating symptoms of prolonged grief are present and 0 indicating insufficient symptoms.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants indicating prolonged grief across the Outlook Intervention and the Relaxation meditation arm, caregivers only. Only six percent of the sample qualified as having prolonged grief, at baseline. Therefore there was not sufficient data for statistical modeling.'}, {'type': 'SECONDARY', 'title': 'Caregiver Preparation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregiver Outlook - Caregiver', 'description': 'Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).'}, {'id': 'OG001', 'title': 'Relaxation Meditation - Caregiver', 'description': 'Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '5 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': '8 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': 'Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 5-item preparation subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparing preparation scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Two scale items were inadvertently left out initially. Items were added back in when omission was noted. However, the large number of missing makes analysis inappropriate.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caregiver Outlook - Caregiver', 'description': 'Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Intervention: Three facilitator-led preparation and life completion sessions with caregiver.\n\nTopics included life review, issues of forgiveness and heritage and legacy.'}, {'id': 'FG001', 'title': 'Caregiver Outlook - Patient', 'description': 'Intervention: Three facilitator-led preparation and life completion sessions with caregiver.\n\nIntervention: Three facilitator-led preparation and life completion sessions with caregiver.\n\nTopics included life review, issues of forgiveness and heritage and legacy.'}, {'id': 'FG002', 'title': 'Relaxation Meditation - Caregiver', 'description': 'Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.'}, {'id': 'FG003', 'title': 'Relaxation Meditation - Patient', 'description': 'Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Excluded by study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'The study conducted recruitment from June 2013 to October 2015. Potential patients were identified by data pulls and then medical record review as well as obtaining approval to approach from providers. Patients were approached both at select outpatient clinics at the Durham VAMC as well as being sent invitation letters with subsequent phone calls.', 'preAssignmentDetails': 'Participant pairs (seriously-ill veteran and primary informal caregiver) were consented and then each completed a baseline interview before the dyad was randomized. Enrolled participants may be excluded if either of the pair refused to consent or did not complete a baseline.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Caregiver Outlook - Caregiver', 'description': 'Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.'}, {'id': 'BG001', 'title': 'Caregiver Outlook - Patient', 'description': 'Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.'}, {'id': 'BG002', 'title': 'Relaxation Meditation - Caregiver', 'description': 'Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.'}, {'id': 'BG003', 'title': 'Relaxation Meditation - Patient', 'description': 'Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD..'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '60.8', 'spread': '11.32', 'groupId': 'BG000'}, {'value': '66.8', 'spread': '7.85', 'groupId': 'BG001'}, {'value': '60.1', 'spread': '12.05', 'groupId': 'BG002'}, {'value': '65.4', 'spread': '9.21', 'groupId': 'BG003'}, {'value': '63.3', 'spread': '10.59', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '141', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '145', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '277', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '145', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'NIH/OMB categories collapsed to: African-American\\\\Black, Caucasian\\\\White Other including more than 1 race, missing', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Dyad Relationship', 'classes': [{'title': 'Spouse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '210', 'groupId': 'BG004'}]}]}, {'title': 'Adult Child', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Sibling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Parent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Respective relationship of participant to other dyad in pair.', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Diagnosis of Veteran', 'classes': [{'title': 'Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}]}, {'title': 'Congestive Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Chronic obstructive pulmonary disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': 'End Stage Renal Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Multiple Qualifying Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Primary life-limiting diagnosis of Veteran patient', 'unitOfMeasure': 'Participants', 'populationDescription': 'Primary diagnosis of veteran only collected from patient half of dyad, which =143'}, {'title': 'Education', 'classes': [{'title': 'HS or less', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '126', 'groupId': 'BG004'}]}]}, {'title': 'Some College', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '107', 'groupId': 'BG004'}]}]}, {'title': 'College Degree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}, {'title': 'Graduate Work or Degree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Finances', 'classes': [{'title': 'Difficulty paying bills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}]}, {'title': 'Money to pay bills, cut back on things', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}, {'title': 'Enough to pay bills, little extras', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '101', 'groupId': 'BG004'}]}]}, {'title': 'enough to pay bills and special things', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported household finances by participant', 'unitOfMeasure': 'Participants'}, {'title': 'Employment', 'classes': [{'title': 'Working Full or Part Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}, {'title': 'Retired/Not Working', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '163', 'groupId': 'BG004'}]}]}, {'title': 'Disabled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported employment', 'unitOfMeasure': 'Participants'}, {'title': 'Self-rated Quality of Health', 'classes': [{'title': 'Excellent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Very Good', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}, {'title': 'Good', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}]}, {'title': 'Fair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}, {'title': 'Poor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '141', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Years of caregiving given or received', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '5.95', 'groupId': 'BG001'}, {'value': '3.7', 'spread': '4.06', 'groupId': 'BG002'}, {'value': '3.4', 'spread': '4.2', 'groupId': 'BG003'}, {'value': '4.2', 'spread': '5.04', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Self-reported years spent caregiving or years received caregiving', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Hours patient requires assistance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.24', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '1.34', 'groupId': 'BG001'}, {'value': '2.3', 'spread': '1.2', 'groupId': 'BG002'}, {'value': '2.1', 'spread': '1.25', 'groupId': 'BG003'}, {'value': '2.3', 'spread': '1.26', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Self-reported number of hours patient requires assistance', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-03', 'studyFirstSubmitDate': '2012-05-11', 'resultsFirstSubmitDate': '2017-01-06', 'studyFirstSubmitQcDate': '2012-08-21', 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-03', 'studyFirstPostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caregiver Anxiety', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': 'Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ).'}], 'secondaryOutcomes': [{'measure': 'Spirituality', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': 'Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale. The 12-item measure assess spiritual well-being: faith, meaning, and purpose. Individual items use a 5 point likert scale (0-4). The scale minimum score is 0 (negative well being) and maximum is 48 (positive well being).'}, {'measure': 'Depression', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': 'Centers for Epidemiologic Study of Depression short form (CES-D) is a 10-item measure of depression. Items are rated on a 4 point Likert scale (0-3) with total scores ranging from 0 to 30. Higher scores indicate greater depressive symptoms'}, {'measure': 'Patient Days of VA Hospital Use', 'timeFrame': 'In the 6 months after randomization', 'description': 'The number of days that a patient used either the VA emergency department (ED) or was an inpatient at a VA hospital in the 6 months following randomization. Inclusion of non-VA utilization was made unpractical due to the long delay in filing for non VA reimbursement (up to 2 years). The original variable was Day AT home, defined to be 180 days minus the days in ED or inpatient hospital. This was changed to days of use due to distribution/modeling considerations.'}, {'measure': 'Caregiver Burden', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': "Caregiver Reaction Assessment (CRA). The Caregiver Reaction Assessment is a 24-item multidimensional instrument designed to measure a caregiver's reactions to caregiving for family members with a variety of chronic illnesses. The esteem subscale has 7 items with a 5 level Likert scale: 1=Strongly Disagree to 5=Strongly Agree. The score is the average of the 7 items ranging from a low score of 1 associated with negative reactions and high score of 5 with positive reactions."}, {'measure': 'Caregiver Completion', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': 'Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 3-item Life Completion subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).'}, {'measure': 'Prolonged Grief - Number of Participants With Anticipatory Grief', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': 'The Prolong Grief Disorder scale is a clinically-based diagnosis determination scale modified for this study. The components/requirements that were dropped were a) diagnosis should not be made until at least 6 months since death, and b) the disturbance is not better accounted for major depressive disorder, generalized anxiety disorder or post traumatic stress disorder. The outcome was a dichotomized variable with 1 indicating symptoms of prolonged grief are present and 0 indicating insufficient symptoms.'}, {'measure': 'Caregiver Preparation', 'timeFrame': 'Measured at baseline, 5 weeks, and 8 weeks', 'description': 'Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 5-item preparation subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['caregiver', 'end of life', 'self-disclosure'], 'conditions': ['Heart Failure', 'Pulmonary Disease', 'Cancer']}, 'descriptionModule': {'briefSummary': 'Informal caregivers provide a majority of care for patients during serious illness. Lack of preparation and completion may leave caregivers less capable of caring for a loved one or making crucial decisions influencing care.\n\nThis study will examine whether a preparation and completion intervention reduces caregiver anxiety, depression, anticipatory grief, and burden and improves patient quality of life and health care use.', 'detailedDescription': 'The investigators propose a randomized control trial to evaluate an intervention of preparation and completion with Veterans and their caregivers during serious illness. Specific aims are to 1) Evaluate the impact of the caregiver Outlook intervention on caregiver anxiety, depression, anticipatory grief, completion, and burden; 2) Evaluate the impact of the home versus in hospital, emergency department, or nursing facility; 3) Evaluate the impact of the intervention session\'s qualitative content, examining variation associated with selected demographic variables, quality of family communication, and stage of illness on change.\n\nCaregivers in the first group ("Treatment", or "Preparation and life completion") will meet with a facilitator three times for a period of forty-five minutes each. In the first session, subjects will be asked to discuss issues related to relationship life review.\n\nIn session two, participants will be asked to speak in more depth about issues such as regret and forgiveness. In the final session, subjects will focus on legacy and celebration. Caregivers in the second group ("attention control" or "relaxation meditation") will meet with a facilitator three times for a period of forty-five minutes each and be asked to listen to a non-guided relaxation compact disk (CD) or participate in a guided relaxation exercise.\n\nParticipants in both groups will receive pre and post-test measures administered by a blinded interviewer. Outcome measures will be measures by the Functional Assessment of Cancer Therapy - General (FACT-G), Quality of life scale, FACIT-sp sub-scale, Anticipatory Grief Scale, Caregiver Reaction Assessment, the Qual-E completion and preparation sub-scales, and patient days at home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with advanced cancer/Congestive heart failure/COPD/End stage renal disease who have a primary caregiver. Caregivers of Durham VAMC patients with advanced disease.\n\nExclusion Criteria:\n\n* No caregiver present.\n* Caregiver with Cognitive impairment/inability to speak on phone/non-English speaking'}, 'identificationModule': {'nctId': 'NCT01672294', 'briefTitle': 'Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness', 'orgStudyIdInfo': {'id': 'IIR 11-347'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment', 'description': 'three facilitator-led end-of-life preparation and completion sessions with a facilitator with both patient and caregiver', 'interventionNames': ['Other: Preparation and life completion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'attention control', 'description': 'three facilitator led sessions of listening to a relaxation CD.', 'interventionNames': ['Other: Attention Control']}], 'interventions': [{'name': 'Preparation and life completion', 'type': 'OTHER', 'description': 'Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy.', 'armGroupLabels': ['treatment']}, {'name': 'Attention Control', 'type': 'OTHER', 'description': 'Caregiver subjects will listen to a non-guided relaxation CD with facilitator.', 'armGroupLabels': ['attention control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center, Durham, NC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Karen E Steinhauser, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Durham VA Medical Center, Durham, NC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}