Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-31 @ 4:22 PM
Study NCT ID:
NCT01382251
Status:
COMPLETED
Last Update Posted:
2014-01-20
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Functional Recovery and Caregiver Burden Following Surgery in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'glbryson@ottawahospital.on.ca', 'phone': '613.761.4169', 'title': 'Dr. Gregory L Bryson', 'organization': 'Department of Anesthesiology, The Ottawa Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Single center, relatively infrequent assessment, assessment of caregiver burden limited to primary caregiver, majority of caregivers were not employed outside the home.'}}, 'adverseEventsModule': {'timeFrame': '30 days following surgery', 'description': 'Adverse event data not collected on caregivers as they did not undergo surgery.', 'eventGroups': [{'id': 'EG000', 'title': 'Ambulatory Surgery Patients', 'otherNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uncontrolled Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Small Bowel Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Functional Autonomy Measurement System (SMAF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambulatory Surgery Patients'}, {'id': 'OG001', 'title': 'Ambulatory Surgery Caregivers'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.0', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'One Week Post-op', 'categories': [{'measurements': [{'value': '10.9', 'spread': '7.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Did not undergo surgery therefore no anticipated change in function', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-op', 'categories': [{'measurements': [{'value': '6.7', 'spread': '7.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Did not undergo surgery therefore no anticipated change in function', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, one week, and one month following surgery', 'description': '29-item scale, each item graded on a four-point scale. 0= independent, 1= needs supervision,2 = needs help, 3 = dependent. Total score ranges from 0 to 87 with higher scores indicating increased disability', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Zarit Burden Interview (ZBI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambulatory Surgery Patients'}, {'id': 'OG001', 'title': 'Ambulatory Surgery Caregivers'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.3', 'spread': '9.9', 'groupId': 'OG001'}]}]}, {'title': 'One Week Post-op', 'categories': [{'measurements': [{'value': '8.9', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-Op', 'categories': [{'measurements': [{'value': '8.6', 'spread': '10.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, one week, and one month following surgery', 'description': 'A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for "never" and 4 for "nearly always." Scores range from 0-88 with higher scores indicating increased burden of care.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Short Form 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambulatory Surgery Patients'}, {'id': 'OG001', 'title': 'Ambulatory Surgery Caregivers'}], 'classes': [{'title': 'Mental Component Score (Baseline)', 'categories': [{'measurements': [{'value': '55.3', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '55.9', 'spread': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component Score (One Week Post-op)', 'categories': [{'measurements': [{'value': '54.9', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '54.4', 'spread': '9.0', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component Score (One Month Post-Op)', 'categories': [{'measurements': [{'value': '56.2', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '54.8', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component Score (Baseline)', 'categories': [{'measurements': [{'value': '43.4', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '50.5', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component Score (One Week Post-op)', 'categories': [{'measurements': [{'value': '35.1', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '51.2', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component Score (One Month Post-op)', 'categories': [{'measurements': [{'value': '42.7', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '51.3', 'spread': '8.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, one week, and one month following surgery', 'description': 'A validated measure of health related quality of life comprised of 12 questions regarding participant experience over the preceding week. Generate Physical And Mental Component scores ranging from 0-100 with higher scores indicating better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI) Functional Interference Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambulatory Surgery Patients'}, {'id': 'OG001', 'title': 'Ambulatory Surgery Caregivers'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'One Week Post-op', 'categories': [{'measurements': [{'value': '2.1', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'One Month Post-op', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, one week, and one month following surgery', 'description': 'Comprised of seven questions in which the subject is asked to describe the extent to which pain interferes with activity. Scores are anchored at 0 for "does not interfere" and 10 for "completely interferes." The seven resulting scores are averaged and reported as a single value (0 - 10) with higher scores indicating greater interference with function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ambulatory Surgery Patients'}, {'id': 'FG001', 'title': 'Ambulatory Surgery Caregivers'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Surgeries cancelled or delayed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Contacted after study closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients \\> 65 yrs scheduled to undergo elective ambulatory orthopedic or peritoneal surgeries were assessed for eligibility. Each patient must have a partner or adult descendant as primary caregiver. Patient-caregiver dyads were approached in the pre-admission unit. Screening began on 2010-07-01 and the final assessment was completed on 2012-01-04.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ambulatory Surgery Patients', 'description': 'Only patients with caregivers were recruited'}, {'id': 'BG001', 'title': 'Ambulatory Surgery Caregivers', 'description': 'Caregivers were recruited with the patients receiving surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Demographic characteristics shown for those patients and caregivers completing study'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-17', 'studyFirstSubmitDate': '2011-06-23', 'resultsFirstSubmitDate': '2013-07-03', 'studyFirstSubmitQcDate': '2011-06-23', 'lastUpdatePostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-17', 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Autonomy Measurement System (SMAF)', 'timeFrame': 'Baseline, one week, and one month following surgery', 'description': '29-item scale, each item graded on a four-point scale. 0= independent, 1= needs supervision,2 = needs help, 3 = dependent. Total score ranges from 0 to 87 with higher scores indicating increased disability'}], 'secondaryOutcomes': [{'measure': 'Zarit Burden Interview (ZBI)', 'timeFrame': 'Baseline, one week, and one month following surgery', 'description': 'A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for "never" and 4 for "nearly always." Scores range from 0-88 with higher scores indicating increased burden of care.'}, {'measure': 'Short Form 12', 'timeFrame': 'Baseline, one week, and one month following surgery', 'description': 'A validated measure of health related quality of life comprised of 12 questions regarding participant experience over the preceding week. Generate Physical And Mental Component scores ranging from 0-100 with higher scores indicating better quality of life.'}, {'measure': 'Brief Pain Inventory (BPI) Functional Interference Score.', 'timeFrame': 'Baseline, one week, and one month following surgery', 'description': 'Comprised of seven questions in which the subject is asked to describe the extent to which pain interferes with activity. Scores are anchored at 0 for "does not interfere" and 10 for "completely interferes." The seven resulting scores are averaged and reported as a single value (0 - 10) with higher scores indicating greater interference with function.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Activities of Daily Living', 'Caregivers', 'Ambulatory Surgical Procedures'], 'conditions': ['Activities of Daily Living', 'Caregivers', 'Ambulatory Surgical Procedures']}, 'referencesModule': {'references': [{'pmid': '23771742', 'type': 'RESULT', 'citation': 'Bryson GL, Clavel NA, Moga R, Power B, Taljaard M, Nathan HJ. Patient function and caregiver burden after ambulatory surgery: a cohort study of patients older than 65. Can J Anaesth. 2013 Sep;60(9):864-73. doi: 10.1007/s12630-013-9982-y. Epub 2013 Jun 15.'}, {'pmid': '25200593', 'type': 'DERIVED', 'citation': 'Bryson GL, Mercer C, Varpio L. Patient and caregiver experience following ambulatory surgery: qualitative analysis in a cohort of patients 65 yr and older. Can J Anaesth. 2014 Nov;61(11):986-94. doi: 10.1007/s12630-014-0229-3. Epub 2014 Sep 9.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the functional recovery of older ambulatory surgical patients and the impact of the current model of care on the caregivers of these patients. This study will provide unique insight into the challenges patients and their families face following surgery.\n\nThe primary objective of this study is to:\n\n1. Assess the impact of ambulatory surgery on functional capacity as assessed by the Système de Mesure de l'Autonomie Fonctionnelle (SMAF) one week and one month following surgery in a population of surgical patients 65 years of age and older.\n\n Secondary objectives are to determine if:\n2. Changes in the patient's functional capacity result in increased burden of care as assessed by the Zarit Burden Interview (ZBI) in the patient's primary caregiver.\n3. Changes in functional capacity are correlated with decrements in quality of life as assessed by the Short Form 12 (SF12).\n4. Changes in functional capacity are correlated with inadequate postoperative analgesia as assessed by the Brief Pain Inventory (BPI)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing ambulatory surgery and their primary caregivers', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients\n\n* aged 65 years and older\n* elective surgery with a planned discharge to the community on the day of the surgical procedure.\n* Eligible surgical procedures include: inguinal herniorrhaphy, ventral herniorrhaphy, laparoscopic cholecystectomy,laparoscopic salpingoophorectomy, urethropexy, cystocoele/rectocoele repair, vaginal hysterectomy, arthroscopic debridement (knee, hip, shoulder), arthroscopic repair (knee, hip, shoulder), removal of hardware from lower extremity, foot surgery, and lumbar discectomy.\n\nCaregiver\n\n\\- spouses, family members, or friends identified as the patient's primary source of support in the community.\n\nExclusion Criteria:\n\nPatients\n\n* Reside in a nursing home providing professional support services;\n* Are unable to complete the study instruments due to cognitive (MMSE \\<24) or physical impairment;\n* Are unable to speak English or French\n\nCaregiver\n\n* Professional caregivers (nurse, personal care assistant, etc) hired to care for the patient;\n* Unable to complete the study instruments due to physical impairment;\n* Unable to Speak English or French"}, 'identificationModule': {'nctId': 'NCT01382251', 'acronym': 'FOCUS', 'briefTitle': 'Functional Recovery and Caregiver Burden Following Surgery in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Functional Recovery and Caregiver Burden Following Surgery in the Elderly', 'orgStudyIdInfo': {'id': '2009390-01H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient', 'description': 'Patients undergoing ambulatory surgery'}, {'label': 'Caregiver', 'description': "Spouse, family members, or friends identified as the patient's primary source of support in the community."}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Gregory L Bryson, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, The Ottawa Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': "Canadian Anesthesiologists' Society", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}