Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-04 @ 3:42 PM
Study NCT ID:
NCT03161860
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-28
First Post:
2017-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Personalised Citizen Assistance for Social Participation(APIC) on Older Adults Health and Social Participation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079102', 'term': 'Empowerment'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Due to the type of intervention, coordinators, volunteers and participants will not be blinded to the interventions. However, they will not be informed about the study hypotheses. Research assistants and the statistician responsible for the analysis will be blinded to the intervention until completion of the study.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2017-05-18', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "v2 of the 36-Item Short-Form Health Survey (SF-36) (''change'' is is being assessed)", 'timeFrame': 'Baseline, 12, 18, 24 months', 'description': 'Physical and mental health'}], 'secondaryOutcomes': [{'measure': 'Social participation scale', 'timeFrame': 'Baseline, 12, 18, 24 months', 'description': 'Social participation'}, {'measure': 'Life Satisfaction Index-Z', 'timeFrame': 'Baseline, 12, 18, 24 months', 'description': 'Life Satisfaction'}, {'measure': 'Use of healthcare services-Standardized questionnaire', 'timeFrame': 'every two months over a 2-year period', 'description': 'Use of healthcare services'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Program evaluation', 'Cost-effectiveness', 'Community participation', 'empowerment'], 'conditions': ['Community-dwelling Older Adults']}, 'referencesModule': {'references': [{'pmid': '38937798', 'type': 'DERIVED', 'citation': 'Levasseur M, Chaintre-Prieur A, Dubois MF, Maisonneuve C, Filiatrault J, Vassiliadis HM. Strengths, challenges, and strategies for implementing pragmatic multicenter randomized controlled trials (RCTs): example of the Personalized Citizen Assistance for Social Participation (APIC) trial. Trials. 2024 Jun 27;25(1):415. doi: 10.1186/s13063-024-08248-w.'}, {'pmid': '29605819', 'type': 'DERIVED', 'citation': "Levasseur M, Dubois MF, Filliatrault J, Vasiliadis HM, Lacasse-Bedard J, Tourigny A, Levert MJ, Gabaude C, Lefebvre H, Berger V, Eymard C. Effect of personalised citizen assistance for social participation (APIC) on older adults' health and social participation: study protocol for a pragmatic multicentre randomised controlled trial (RCT). BMJ Open. 2018 Mar 31;8(3):e018676. doi: 10.1136/bmjopen-2017-018676."}]}, 'descriptionModule': {'briefSummary': "Global aging and the growing burden of chronic diseases represent a challenge. Innovative interventions acting upon health determinants, like social participation, are required. Social participation, defined as the involvement of a person in activities that provide interactions with others in the community is critical to promote health and prevent disabilities. Many older adults do not have equitable opportunities to achieve full social participation, and interventions under-empower their personal and environmental resources and only reach a minority. To optimize current practices, the Personalised citizen assistance for social participation (APIC), an intervention demonstrated as being feasible and having positive impacts, needs further evaluation.\n\nThe first aim of this study is evaluate the impacts of the APIC on older adults' health, social participation, life satisfaction and healthcare services utilisation. The second aim is to evaluate the cost-effectiveness of the intervention. In parallel, the implementation of the APIC, including factors facilitating and impeding it, will be documented.\n\nConcerning the first two objectives, two hypotheses are formulated: 1) the APIC will prevent a decline in older women's and men's health, social participation and life satisfaction, and reduce their use of healthcare services, and 2) the APIC will be associated with lower costs, from older adults', healthcare system and societal perspectives, including healthcare expenditures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. be aged 65 or older,\n2. live at home or in seniors' residences,\n3. be restricted in at least one instrumental activity of daily living (e.g. house cleaning, shopping), and\n4. have a good understanding of French or English.\n\nExclusion Criteria:\n\n* Moderate to severe cognitive impairments"}, 'identificationModule': {'nctId': 'NCT03161860', 'acronym': 'APIC', 'briefTitle': 'Effect of Personalised Citizen Assistance for Social Participation(APIC) on Older Adults Health and Social Participation', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': "Effect of Personalised Citizen Assistance for Social Participation (APIC) on Older Adults' Health and Social Participation: a Pragmatic Multicentre Randomised Controlled Trial (RCT)", 'orgStudyIdInfo': {'id': 'MP-31-2018-2424'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personalised citizen assistance', 'description': 'The experimental group will receive the Personalised citizen assistance for social participation (APIC), i.e. weekly 3-hour personalised stimulation sessions by a trained volunteer over 12 months. Sessions will encourage empowerment, gradual mobilisation of personal and environmental resources, and community integration.', 'interventionNames': ['Behavioral: Personalised citizen assistance for social participation(APIC)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will receive the publicly-funded universal healthcare services available to all Quebecers.'}], 'interventions': [{'name': 'Personalised citizen assistance for social participation(APIC)', 'type': 'BEHAVIORAL', 'description': 'The APIC involves a non-professional attendant who, after 2 to 5 days of training, provides a two to three-hour stimulation session each week over a six to eighteen-month period targeting significant social and leisure activities that are otherwise difficult for older adults to accomplish.', 'armGroupLabels': ['Personalised citizen assistance']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J2C 3W1', 'city': 'Drummondville', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre d'action bénévole Drummond", 'geoPoint': {'lat': 45.88336, 'lon': -72.48241}}, {'zip': 'G6V 1N6', 'city': 'Lévis', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre d'action bénévole Bellechasse-Lévis-Lotbinière", 'geoPoint': {'lat': 46.80326, 'lon': -71.17793}}, {'zip': 'H1K 4J4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Service d'aide et de référencement Anjou (SARA-Anjou)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H1X 2X2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Carrefour communautaire Montrose', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4L 3Y6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre ABC', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J1H 5N6', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Accorderie de Sherbrooke, coopérative de solidarité', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Mélanie Levasseur', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke; Research centre on aging'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mélanie Levasseur', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Professor', 'investigatorFullName': 'Mélanie Levasseur', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}