Community-dwelling Older AdultsAPICNCT03161860
Effect of Personalised Citizen Assistance for Social Participation(APIC) on Older Adults Health and Social Participation
A study testing Personalised citizen assistance for social participation(APIC) in people with Community-dwelling Older Adults, run by Mélanie Levasseur at 6 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Community-dwelling Older Adults
- What is being tested?
- Personalised citizen assistance for social participation(APIC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesCanada
- Study dates
- 4 Oct 2017to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- be aged 65 or older,
- live at home or in seniors' residences,
- be restricted in at least one instrumental activity of daily living (e.g. house cleaning, shopping), and
- have a good understanding of French or English.
Who cannot join
- Moderate to severe cognitive impairments
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Centre d'action bénévole Drummond
Drummondville, Quebec, J2C 3W1
Centre d'action bénévole Bellechasse-Lévis-Lotbinière
Lévis, Quebec, G6V 1N6
Service d'aide et de référencement Anjou (SARA-Anjou)
Montreal, Quebec, H1K 4J4
Carrefour communautaire Montrose
Montreal, Quebec, H1X 2X2
Centre ABC
Montreal, Quebec, H4L 3Y6
Accorderie de Sherbrooke, coopérative de solidarité
Sherbrooke, Quebec, J1H 5N6
About this study
Official title: Effect of Personalised Citizen Assistance for Social Participation (APIC) on Older Adults' Health and Social Participation: a Pragmatic Multicentre Randomised Controlled Trial (RCT)
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.
The 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.
Concerning 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.
- Conditions
- Community-dwelling Older Adults
- Being tested
- Personalised citizen assistance for social participation(APIC)
- Keywords
- Program evaluation, Cost-effectiveness, Community participation, empowerment
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised citizen assistance for social participation(APIC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalised citizen assistance | Experimental | 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. Receives: Behavioral: Personalised citizen assistance for social participation(APIC) |
| Control group | No intervention | The control group will receive the publicly-funded universal healthcare services available to all Quebecers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
v2 of the 36-Item Short-Form Health Survey (SF-36) (''change'' is is being assessed)
Physical and mental health
Measured: Baseline, 12, 18, 24 months
Secondary outcomes (3)
Social participation scale
Social participation
Measured: Baseline, 12, 18, 24 months
Life Satisfaction Index-Z
Life Satisfaction
Measured: Baseline, 12, 18, 24 months
Use of healthcare services-Standardized questionnaire
Use of healthcare services
Measured: every two months over a 2-year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start4 Oct 2017
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Community-dwelling Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mélanie Levasseur
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Mélanie Levasseur, Université de Sherbrooke
- Investigators
- Mélanie Levasseur, Principal investigator, Université de Sherbrooke; Research centre on aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161860
- Sponsor's protocol ID
- MP-31-2018-2424
- Acronym
- APIC
- Status last verified
- Dec 2024
- First submitted
- 17 May 2017
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38937798Levasseur 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.
PubMed 29605819
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Personalised Citizen Assistance for Social Participation (APIC) on Older Adults' Health and Social Participation: a Pragmatic Multicentre Randomised Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT03161860
- Acronym / sponsor ID
- APIC / MP-31-2018-2424
- Conditions
- Community-dwelling Older Adults
- Keywords
- Program evaluation, Cost-effectiveness, Community participation, empowerment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mélanie LevasseurUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The 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.
Concerning 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalised citizen assistance | Experimental | Behavioral: Personalised citizen assistance for social participation(APIC)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. |
| Control group | No intervention | –The control group will receive the publicly-funded universal healthcare services available to all Quebecers. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- be aged 65 or older,
- live at home or in seniors' residences,
- be restricted in at least one instrumental activity of daily living (e.g. house cleaning, shopping), and
- have a good understanding of French or English.
Key exclusion criteria (1 listed)
- Moderate to severe cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalised citizen assistance for social participation(APIC)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. | Behavioural | Personalised citizen assistance |
Primary outcome
v2 of the 36-Item Short-Form Health Survey (SF-36) (''change'' is is being assessed)
Time frame: Baseline, 12, 18, 24 months
Physical and mental health
3 secondary outcomes
Social participation scale
Time frame: Baseline, 12, 18, 24 months
Life Satisfaction Index-Z
Time frame: Baseline, 12, 18, 24 months
Use of healthcare services-Standardized questionnaire
Time frame: every two months over a 2-year period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 38937798Levasseur 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.
- Derived from this study: PubMed 29605819Levasseur 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mélanie Levasseur principal investigator
Université de Sherbrooke; Research centre on aging
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalised citizen assistance for social participation(APIC) in people with Community-dwelling Older Adults, run by Mélanie Levasseur at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
v2 of the 36-Item Short-Form Health Survey (SF-36) (''change'' is is being assessed) (time frame: Baseline, 12, 18, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03161860, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.