Frail ElderlyNCT02622828
Increasing the Winter Community Participation of Older Adult Wheelchair Users
A study testing Participant-identified community based activity in people with Frail Elderly, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to examine whether intervention strategies targeted at the level of the environment (e.g. improving access to community based leisure groups, transportation) can successfully promote the community participation experiences of community-dwelling older adult Manitobans who use wheelchairs in… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Participant-identified community based activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2015to 15 Sep 2017
- Phase
- Interventional
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 70 or older, user of a manual or power wheelchair or scooter for outdoor mobility
- Self-identifies a reduction in community participation throughout the winter months
- Community-dwelling
- Lives within the perimeter of Winnipeg.
Who cannot join
- Geriatric Depression Scale-SF score of 6 or more
- Montreal Cognitive Assessment score of 25 or less
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine whether intervention strategies targeted at the level of the environment (e.g. improving access to community based leisure groups, transportation) can successfully promote the community participation experiences of community-dwelling older adult Manitobans who use wheelchairs in the winter.
Read the detailed description
There is strong evidence to support that community-dwelling older adults who are able to maintain their involvement in social, recreational, spiritual and physical activities experience positive effects on their health and quality of life. While winter creates challenges to community participation for many Manitobans, these difficulties are magnified for older adults and particularly for older adults who use wheelchairs. The aim of this study is to explore ways to improve or maintain community participation of community-dwelling older adults who use wheelchairs in the winter. Using a single-subject design, five older adult Manitobans who are wheelchair users will each select three community-based participation goals to work on throughout the winter months. Each older adult participant will work with an occupational therapist to receive individually-focused interventions aimed at increasing his or her community participation. The investigators will use a client-centered outcome measure designed to detect changes in performance and satisfaction in the goals that the individual has self-identified as being important to him or her, yet difficult to perform. The findings of this study will help determine the feasibility of conducting a larger scale study that would include a greater number of older adult Manitobans. Older adult wheelchair users in Manitoba bear a disproportionate burden in the winter when aging, mobility limitations, and weather coincide to create conditions that make community participation exceedingly difficult. It is important to the health and well-being of older adult Manitobans to find effective ways to promote community engagement throughout the winter months.
- Conditions
- Frail Elderly
- Being tested
- Participant-identified community based activity
- Keywords
- wheelchairs, social participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participant-identified community based activityBehavioural
The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM will be used to set self-identified, community-based activities as treatment goals.
| Study group | Role | What they receive |
|---|---|---|
| Behavioural | Other | Participant-identified community based activity Receives: Behavioral: Participant-identified community based activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Occupational Performance Using the The Canadian Occupational Performance Measure (COPM) at 5 Months
The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM has well-established psychometric properties and will be used as the primary outcome measure and will be used to set treatment goals, determine baseline stability, and detect change in performance of, and satisfaction with, the goals.
Measured: Initial and 5 month follow up
Secondary outcomes (1)
World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS2)
The WHO-DAS 2.0 is a generic self-report health status measure, linked to the concepts of health and disability outlined in the International Classification of Functioning, Disability and Health and is intended to identify limitations in six domains with 36 items, including self-care, and community and social functioning experienced over the past 30 days. The WHO-DAS 2.0 is responsive to change, has excellent internal consistency, established content validity, and high convergent validity. The WHO-DAS 2.0 will be used to identify changes in overall health status that occur through the study. Uses a scale of 1-5 - 1=no difficulty and 5=extreme difficulty or cannot do. Sum of items within each domain are then summed across the 6 domains to result in a general disability summary score, converted to a metric from 0-100 with higher score indicating more disability.
Measured: Initial and 5 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study start1 Dec 2015
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Why it stopped: Unable to recruit needed participants
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 Frail ElderlyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacquie Ripat, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622828
- Sponsor's protocol ID
- H2015:132
- Status last verified
- Aug 2016
- First submitted
- 1 Dec 2015
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Winter Community Participation of Older Adult Wheelchair Users
- ClinicalTrials.gov ID
- NCT02622828
- Acronym / sponsor ID
- H2015:132
- Conditions
- Frail Elderly
- Keywords
- wheelchairs, social participation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit needed participants
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether intervention strategies targeted at the level of the environment (e.g. improving access to community based leisure groups, transportation) can successfully promote the community participation experiences of community-dwelling older adult Manitobans who use wheelchairs in the winter.
Detailed description
There is strong evidence to support that community-dwelling older adults who are able to maintain their involvement in social, recreational, spiritual and physical activities experience positive effects on their health and quality of life. While winter creates challenges to community participation for many Manitobans, these difficulties are magnified for older adults and particularly for older adults who use wheelchairs. The aim of this study is to explore ways to improve or maintain community participation of community-dwelling older adults who use wheelchairs in the winter. Using a single-subject design, five older adult Manitobans who are wheelchair users will each select three community-based participation goals to work on throughout the winter months. Each older adult participant will work with an occupational therapist to receive individually-focused interventions aimed at increasing his or her community participation. The investigators will use a client-centered outcome measure designed to detect changes in performance and satisfaction in the goals that the individual has self-identified as being important to him or her, yet difficult to perform. The findings of this study will help determine the feasibility of conducting a larger scale study that would include a greater number of older adult Manitobans. Older adult wheelchair users in Manitoba bear a disproportionate burden in the winter when aging, mobility limitations, and weather coincide to create conditions that make community participation exceedingly difficult. It is important to the health and well-being of older adult Manitobans to find effective ways to promote community engagement throughout the winter months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioural | Other | Behavioral: Participant-identified community based activityParticipant-identified community based activity |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 70 or older, user of a manual or power wheelchair or scooter for outdoor mobility
- Self-identifies a reduction in community participation throughout the winter months
- Community-dwelling
- Lives within the perimeter of Winnipeg.
Key exclusion criteria (2 listed)
- Geriatric Depression Scale-SF score of 6 or more
- Montreal Cognitive Assessment score of 25 or less
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 |
|---|---|---|
| Participant-identified community based activityThe Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM will be used to set self-identified, community-based activities as treatment goals. | Behavioural | Behavioural |
Primary outcome
Change in Occupational Performance Using the The Canadian Occupational Performance Measure (COPM) at 5 Months
Time frame: Initial and 5 month follow up
The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM has well-established psychometric properties and will be used as the primary outcome measure and will be used to set treatment goals, determine baseline stability, and detect change in performance of, and satisfaction with, the goals.
1 secondary outcome
World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS2)
Time frame: Initial and 5 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jacquie Ripat, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participant-identified community based activity in people with Frail Elderly, run by University of Manitoba 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 4 Oct 2019. 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 4 Oct 2019). 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?
Change in Occupational Performance Using the The Canadian Occupational Performance Measure (COPM) at 5 Months (time frame: Initial and 5 month follow up). 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 4 Oct 2019.