Sense of Community437_EsComNCT06441877
Community Spirit in Residence for the Elderly
An observational study of Sense of Community, run by TOPMED at 1 site in Canada.
Trial summary
The objective of our study is to observe and understand factors that emphasizes the creation of a community spirit. Specific objectives: 1. Explore and understand the facilitators and challenges of social participation in a residential context; 2. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sense of Community
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 7 May 2024to 14 Jan 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly home care residents and the managers that work on site. The participants will be sampled from the selected community homes.
Who may be able to join
- For site managers
- Be a manager in the residences concerned
- Be a department manager or
- Hold a General Manager position or
- Be a member of the partner's head office
- For residents
- Residents of the autonomous wing of the targeted residences
- Close caregiver of a resident of the residences included in the research project
Who cannot join
- Neurocognitive disorders
- Significant language difficulties
- Lack of verbal communication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Elder at the Heart of His or Her Living Environment - Social Participation and Community Spirit in Residence for the Elderly
The objective of our study is to observe and understand factors that emphasizes the creation of a community spirit.
Specific objectives:
- Explore and understand the facilitators and challenges of social participation in a residential context;
- Explore and understand the facilitators and challenges of creating a sense of community in a residential setting.
- Conditions
- Sense of Community
- Being tested
- No intervention
- Keywords
- sense of community, social participation, sense of belonging, social cohesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention, this is an observationnal study.
| Study group | Role | What they receive |
|---|---|---|
| Residents site 1 | Elderly residents who live in elderly home care service site 1 Receives: Other: No intervention | |
| Residents site 2 | Elderly residents who live in elderly home care service site 2 Receives: Other: No intervention | |
| Managers site 1 | Managers who work for the elderly home care service at site 1 Receives: Other: No intervention | |
| Managers site 2 | Managers who work for the elderly home care service at site 2 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sense of Community Factors
13 items questionnaire with open questions in individual interview session format, factors are identified through qualitative analysis.
Measured: Up to 1 month after participants' recruitment
Sense of Community
9 items questionnaire used to measure the sense of community of the residents. For managers, the measure is their perception of the resident's sense of community. Each item uses a 5 point scale, higher score means higher sense of community, minimum value per item: 1, maximum value per item: 5, minimum total score: 9, maximum total score : 45
Measured: Up to two weeks prior to the interview session
Secondary outcomes (2)
Sense of Community Facilitators
7 subitems asked in the questionnaire with open questions in individual interview session format, facilitators are identified through qualitative analysis.
Measured: Up to 1 month after participants' recruitment
Sense of Community Obstacles
8 subitems asked in the questionnaire with open questions in individual interview session format, obstacles are identified through qualitative analysis.
Measured: Up to 1 month after participants' recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start7 May 2024
- Primary completion4 Jun 2024
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sense of CommunityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- TOPMED
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441877
- Sponsor's protocol ID
- 437_Esprit communauté
- Acronym
- 437_EsCom
- Status last verified
- Apr 2025
- First submitted
- 3 May 2024
- Last updated
- 20 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Elder at the Heart of His or Her Living Environment - Social Participation and Community Spirit in Residence for the Elderly
- ClinicalTrials.gov ID
- NCT06441877
- Acronym / sponsor ID
- 437_EsCom / 437_Esprit communauté
- Conditions
- Sense of Community
- Keywords
- sense of community, social participation, sense of belonging, social cohesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- TOPMEDUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of our study is to observe and understand factors that emphasizes the creation of a community spirit.
Specific objectives:
- Explore and understand the facilitators and challenges of social participation in a residential context;
- Explore and understand the facilitators and challenges of creating a sense of community in a residential setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Residents site 1 | – | Other: No interventionElderly residents who live in elderly home care service site 1 |
| Residents site 2 | – | Other: No interventionElderly residents who live in elderly home care service site 2 |
| Managers site 1 | – | Other: No interventionManagers who work for the elderly home care service at site 1 |
| Managers site 2 | – | Other: No interventionManagers who work for the elderly home care service at site 2 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly home care residents and the managers that work on site. The participants will be sampled from the selected community homes.
Key inclusion criteria (8 listed)
- For site managers
- Be a manager in the residences concerned
- Be a department manager or
- Hold a General Manager position or
- Be a member of the partner's head office
Key exclusion criteria (3 listed)
- Neurocognitive disorders
- Significant language difficulties
- Lack of verbal communication
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 |
|---|---|---|
| No interventionThere is no intervention, this is an observationnal study. | Other | Managers site 1, Managers site 2, Residents site 1, Residents site 2 |
Primary outcome
Sense of Community Factors
Time frame: Up to 1 month after participants' recruitment
13 items questionnaire with open questions in individual interview session format, factors are identified through qualitative analysis.
Sense of Community
Time frame: Up to two weeks prior to the interview session
9 items questionnaire used to measure the sense of community of the residents. For managers, the measure is their perception of the resident's sense of community. Each item uses a 5 point scale, higher score means higher sense of community, minimum value per item: 1, maximum value per item: 5, minimum total score: 9, maximum total score : 45
2 secondary outcomes
Sense of Community Facilitators
Time frame: Up to 1 month after participants' recruitment
Sense of Community Obstacles
Time frame: Up to 1 month after participants' recruitment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sense of Community, run by TOPMED at 1 site 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 8 inclusion and 3 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: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sense of Community Factors (time frame: Up to 1 month after participants' recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2025.