Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT00229957
Status:
COMPLETED
Last Update Posted:
2010-07-20
First Post:
2005-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009788', 'term': 'Occupational Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D000073278', 'term': 'Self-Management'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jrichard@mcmaster.ca', 'phone': '905-525-9140', 'title': 'Dr. Julie Richardson', 'phoneExt': '27811', 'organization': 'McMaster University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': 'A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.', 'otherNumAtRisk': 152, 'otherNumAffected': 0, 'seriousNumAtRisk': 152, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Usual care from the primary health care team which did not include physiotherapy or occupational therapy.', 'otherNumAtRisk': 151, 'otherNumAffected': 0, 'seriousNumAtRisk': 151, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SF-36 Physical Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Usual care from the primary health care team which did not include physiotherapy or occupational therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.6', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '43.1', 'spread': '11.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 months', 'description': 'health related quality of life. Minimum: 0; Maximum 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Hospital Services', 'paramType': 'MEAN', 'timeFrame': 'baseline, 15 months', 'description': 'self report use of hospital service', 'unitOfMeasure': 'planned hospital days, ER visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2009-07'}, {'type': 'SECONDARY', 'title': 'Independence in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)', 'paramType': 'MEAN', 'timeFrame': 'baseline, 15 months', 'description': 'Late Life Function and Disability Instrument: A measure of disability and functional limitations in older adults. (Score range 0-100 with 100 representing better ability and less disability/functional limitation)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2009-08'}, {'type': 'SECONDARY', 'title': 'Functional Limitations', 'paramType': 'MEAN', 'timeFrame': 'baseline, 15 months', 'description': 'Late Life Function and Disability Instrument: A measure of functional limitations and disability in older adults.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2009-08'}, {'type': 'SECONDARY', 'title': 'Falls and Injuries', 'paramType': 'MEAN', 'timeFrame': 'baseline, 15 months', 'description': 'self-reported number of falls in last 6 months', 'unitOfMeasure': 'number of falls', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2009-08'}, {'type': 'SECONDARY', 'title': 'HOME Falls and Accident Screening Tool (FAST)', 'paramType': 'MEAN', 'timeFrame': 'baseline, 15 months', 'description': "This is a home assessment of safety hazards for falls present in the individual's home. This tool helps to identify seniors at risk of falls. Score 0-25.", 'unitOfMeasure': 'number', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2009-08'}, {'type': 'SECONDARY', 'title': 'Self-management and Self-efficacy', 'paramType': 'MEAN', 'timeFrame': 'baseline, 15 months', 'description': "Individual's self-reported ability to carry out behaviours to self-manage their health condition, and their confidence level in being able to carry out these behaviours. (Score range 0= not confident at all, 10= totally confident).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2009-08'}, {'type': 'SECONDARY', 'title': 'Physical Abilities (Strength, Balance)', 'paramType': 'MEAN', 'timeFrame': 'baseline, 15 months', 'description': 'Grip strength was measured using a JAMAR hand grip dynamometer (in kilograms). The Lower Extremity Function test is a battery of three tests used to measure lower extremity function and balance: a balance test, 8 foot walk test, and repetitive standing from a chair. A performance summary score is created by adding the number of seconds achieved on the balance test, the number of seconds to walk 8 feet and the number of seconds it takes the person to stand up from a chair five times consecutively (no maximum score exists on this measure).', 'unitOfMeasure': 'kilograms, seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2009-08'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Questionnaire - 18 (Modified)', 'paramType': 'MEAN', 'timeFrame': '15 months', 'description': 'Patient satisfaction with the care they received. (Score range 0-5)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Usual care from the primary health care team which did not include physiotherapy or occupational therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'All participants recruited from a family health practice.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Usual care from the primary health care team which did not include physiotherapy or occupational therapy.'}, {'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': '86', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 303}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-13', 'studyFirstSubmitDate': '2005-09-28', 'resultsFirstSubmitDate': '2009-05-18', 'studyFirstSubmitQcDate': '2005-09-28', 'lastUpdatePostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-07', 'studyFirstPostDateStruct': {'date': '2005-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SF-36 Physical Component', 'timeFrame': '15 months', 'description': 'health related quality of life. Minimum: 0; Maximum 100.'}], 'secondaryOutcomes': [{'measure': 'Use of Hospital Services', 'timeFrame': 'baseline, 15 months', 'description': 'self report use of hospital service'}, {'measure': 'Independence in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)', 'timeFrame': 'baseline, 15 months', 'description': 'Late Life Function and Disability Instrument: A measure of disability and functional limitations in older adults. (Score range 0-100 with 100 representing better ability and less disability/functional limitation)'}, {'measure': 'Functional Limitations', 'timeFrame': 'baseline, 15 months', 'description': 'Late Life Function and Disability Instrument: A measure of functional limitations and disability in older adults.'}, {'measure': 'Falls and Injuries', 'timeFrame': 'baseline, 15 months', 'description': 'self-reported number of falls in last 6 months'}, {'measure': 'HOME Falls and Accident Screening Tool (FAST)', 'timeFrame': 'baseline, 15 months', 'description': "This is a home assessment of safety hazards for falls present in the individual's home. This tool helps to identify seniors at risk of falls. Score 0-25."}, {'measure': 'Self-management and Self-efficacy', 'timeFrame': 'baseline, 15 months', 'description': "Individual's self-reported ability to carry out behaviours to self-manage their health condition, and their confidence level in being able to carry out these behaviours. (Score range 0= not confident at all, 10= totally confident)."}, {'measure': 'Physical Abilities (Strength, Balance)', 'timeFrame': 'baseline, 15 months', 'description': 'Grip strength was measured using a JAMAR hand grip dynamometer (in kilograms). The Lower Extremity Function test is a battery of three tests used to measure lower extremity function and balance: a balance test, 8 foot walk test, and repetitive standing from a chair. A performance summary score is created by adding the number of seconds achieved on the balance test, the number of seconds to walk 8 feet and the number of seconds it takes the person to stand up from a chair five times consecutively (no maximum score exists on this measure).'}, {'measure': 'Patient Satisfaction Questionnaire - 18 (Modified)', 'timeFrame': '15 months', 'description': 'Patient satisfaction with the care they received. (Score range 0-5)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Occupational therapy', 'Physical therapy techniques', 'Primary health care', 'Chronic disease', 'Rehabilitation', 'Disease management', 'Self care'], 'conditions': ['Chronic Disease', 'Hypertension', 'Back Pain', 'Obesity', 'Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether occupational therapy and physiotherapy delivered in a primary care setting to adults with chronic illness is effective in improving health.', 'detailedDescription': 'Primary health care is changing so that people receive the care that they need at the front line. Rehabilitation has been identified as one service that should be offered in primary care, to address the needs of adults who have or are at risk of poor health from chronic conditions such as arthritis, heart disease and depression.\n\nTwo full time therapists (one physiotherapist and one occupational therapist) will offer rehabilitation to a sample of 170 adults with chronic illness over an 18 month period (170 people will also be enrolled in a control group) at the Stonechurch Family Health Centre. Key outcomes include health, hospital admissions and emergency room visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '44 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 1 chronic condition\n* 3 visits to family physician in the past year\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00229957', 'briefTitle': 'Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness', 'orgStudyIdInfo': {'id': '04-052'}, 'secondaryIdInfos': [{'id': 'G03-02572'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intervention', 'interventionNames': ['Behavioral: Occupational therapy', 'Behavioral: Physiotherapy', 'Behavioral: Self-management']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group received usual care in primary care.'}], 'interventions': [{'name': 'Occupational therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention']}, {'name': 'Physiotherapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention']}, {'name': 'Self-management', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8W 3L2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Stonechurch Family Health Centre, 549 Stonechurch Rd. E.', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Lori Letts, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}, {'name': 'Julie Richardson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ontario Ministry of Health and Long Term Care', 'class': 'OTHER_GOV'}]}}}