Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:42 PM
Study NCT ID:
NCT00321269
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2006-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Depression and Congestive Heart Failure in Outpatients.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Carolyn-Turvey@uiowa.edu', 'phone': '319 338 0581', 'title': 'Carolyn Turvey', 'phoneExt': '7714', 'organization': 'Iowa City VA Health Care System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks- duration of the clinical trial. Adverse event was assessed at Week 4 and Week 8.', 'description': 'Participants indicating depression were assessed for suicidality and any mortality due to suicide was monitored. These were the only adverse events monitored specifically.\n\nSuicidal ideation was assessed using the Beck Depression Inventory (Question #9) and the Structured Clinical Interview for DSM (Suicidal ideation question).', 'eventGroups': [{'id': 'EG000', 'title': '8-week Telephone Based Single Illness Management', 'description': 'Standard nursing intervention to treat Congestive Heart Failure\n\nEducation \\& behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure', 'otherNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '8-Week Phone Based Comorbid Illness Management', 'description': 'Nursing intervention to treat Congestive Heart Failure and emotional coping\n\nCHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping', 'otherNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Beck Depression Inventory II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '8-week Phone-based Single Illness Management', 'description': 'Standard nursing intervention to treat Congestive Heart Failure\n\nEducation \\& behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure'}, {'id': 'OG001', 'title': '8-week Phone-based Comorbid Illness Management', 'description': 'Nursing intervention to treat Congestive Heart Failure and emotional coping\n\nCHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '9.3', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '9.0', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '0.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Mixed effects regression analysis- Treatment Arm X Time F (2, 116)=0.09, P\\>F=0.90.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Depression and psychological health will be assessed at week 1, week 8', 'description': 'Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63. Higher scores indicate greater depression. Effectiveness of treatment indicated by a decline in the BDI-II score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Older Veterans with Heart Failure'}, {'type': 'SECONDARY', 'title': 'Health-Related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '8-Week Phone-Based Single Illness Management', 'description': 'Standard nursing intervention to treat Congestive Heart Failure\n\nEducation \\& behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure'}, {'id': 'OG001', 'title': '8-Week Phone-Based Comorbid Illness Management', 'description': 'Nursing intervention to treat Congestive Heart Failure and emotional coping\n\nCHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '36.82', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '37.2', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '36.5', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '43.1', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'F(2,110)=2.08; P=0.13', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at week 1, week 8', 'description': 'Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Older Veterans with Congestive Heart Failure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '8-week Phone Based Single Illness Management', 'description': 'Standard nursing intervention to treat Congestive Heart Failure\n\nEducation \\& behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure'}, {'id': 'FG001', 'title': '8-week Phone Based Comorbid Illness Management', 'description': 'Nursing intervention to treat Congestive Heart Failure and emotional coping\n\nCHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '8-week Phone Based Single Illness Management', 'description': 'Standard nursing intervention to treat Congestive Heart Failure\n\nEducation \\& behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure'}, {'id': 'BG001', 'title': '8-Week Phone-based Comorbid Illness Management', 'description': 'Nursing intervention to treat Congestive Heart Failure and emotional coping\n\nCHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.4', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '67.8', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '70.1', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-23', 'studyFirstSubmitDate': '2006-05-01', 'resultsFirstSubmitDate': '2014-11-12', 'studyFirstSubmitQcDate': '2006-05-01', 'lastUpdatePostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-21', 'studyFirstPostDateStruct': {'date': '2006-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Depression Inventory II', 'timeFrame': 'Depression and psychological health will be assessed at week 1, week 8', 'description': 'Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63. Higher scores indicate greater depression. Effectiveness of treatment indicated by a decline in the BDI-II score.'}], 'secondaryOutcomes': [{'measure': 'Health-Related Quality of Life', 'timeFrame': 'Measured at week 1, week 8', 'description': 'Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Home Monitoring', 'Heart Failure', 'Depression'], 'conditions': ['Heart Failure', 'Depression']}, 'referencesModule': {'references': [{'pmid': '22933480', 'type': 'RESULT', 'citation': 'Turvey C, Sheeran T, Dindo L, Wakefield B, Klein D. Validity of the Patient Health Questionnaire, PHQ-9, administered through interactive-voice-response technology. J Telemed Telecare. 2012 Sep;18(6):348-51. doi: 10.1258/jtt.2012.120220. Epub 2012 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'Patients with a diagnosis of CHF, NYHA class II, III or IV will be recruited for a study comparing a nursing intervention addressing CHF (SIM group) or CHF and depression (CIM group). Participants in the standard illness management program will receive an 8-week, 8-session intervention designed to help them improve daily weighing, salt-restriction, medication management, etc. This intervention will be conducted in a combination of home visits and phone visits. They will also receive interactive, telephone-based daily monitoring that assesses daily weight, dyspnea, fatigue and medication compliance. Patients in the comorbid illness management program will receive the same illness management program PLUS education and behavioral techniques designed to help them cope emotionally with the illness. The comorbid illness management home monitoring will include a twice-monthly screen for depression. Major Variables: The major outcomes will be depressive symptoms, health-related quality of life, functional status, heart failure symptom severity, and self-care behaviors in heart failure.', 'detailedDescription': 'Background:\n\nBetween 4 and 5% of patients seen at Veterans Affairs Medical Centers suffer heart failure. HF is the number one discharge diagnosis within the VHA. One of the most significant comorbidities in heart failure is depression. Depression predicts increased hospitalization and mortality even after controlling for key prognostic indicators. This HSR\\&D study aimed to test the effectiveness of a psychotherapy intervention for depression combined with illness management to illness management alone in veterans with heart failure.\n\nObjectives:\n\nTo demonstrate better depression, health-related quality-of-life, and adherence outcomes for an illness management combined with psychotherapy intervention (COMBO) as compared to an illness management alone program (IMO).\n\nMethods:\n\nThis was a two-site, two-arm, randomized controlled trial comparing COMBO to IMO. The total number of patients recruited for the study was 148. Retention was comparable between groups, though depression severity predicted drop out in the IMO condition but not the COMBO condition. Patients completed study assessments at baseline, week 4, week 8 (post-intervention) and at 26- and 52-week follow-up.\n\nStatus:\n\nThe main study analyses have been conducted. The project team is conducting analysis of secondary hypotheses'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving treatment for NYHA Class 2-4 heart failure.\n* Patients of the Iowa City, IA or Columbia, MO Veterans Affairs Medical Center Primary Care or Cardiac Care Clinics.\n* Life expectancy greater than 6 months.\n* Must speak English.\n* Must possess a working telephone.\n\nExclusion Criteria:\n\n* Presence of major psychiatric illness such as schizophrenia, bipolar disorder and substance abuse (PTSD patients are eligible).\n* Life expectancy less than 3 months.\n* Planned relocation to a nursing home.\n* Marked visual or hearing impairment.'}, 'identificationModule': {'nctId': 'NCT00321269', 'briefTitle': 'Depression and Congestive Heart Failure in Outpatients.', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Depression and CHF in Outpatients', 'orgStudyIdInfo': {'id': 'IIR 06-082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single Illness Managment', 'description': 'This intervention includes standard disease self-management coaching for heart failure and helps patients set goals for fluid management, restricted salt-intake, and medication adherence.', 'interventionNames': ['Behavioral: Single Illness Management']}, {'type': 'EXPERIMENTAL', 'label': 'Comorbid Illness Management', 'description': 'This intervention includes the same self-management coaching found in the comparator arm, but also includes discussion of ways to cope and manage mood.', 'interventionNames': ['Behavioral: Comorbid Illness Management']}], 'interventions': [{'name': 'Single Illness Management', 'type': 'BEHAVIORAL', 'description': '8 week nursing intervention addressing Congestive Heart Failure', 'armGroupLabels': ['Single Illness Managment']}, {'name': 'Comorbid Illness Management', 'type': 'BEHAVIORAL', 'description': '8 week nursing intervention to address Congestive Heart Failure and emotional coping', 'armGroupLabels': ['Comorbid Illness Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52246', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa City VA Medical Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '65201-5297', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Harry S. Truman Memorial VA Medical Center', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Carolyn L Turvey, PhD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Medical Center, Iowa City'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}