- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02622828
Increasing the Winter Community Participation of Older Adult Wheelchair Users
2 oktober 2019 uppdaterad av: University of Manitoba
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
4
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada, R3E0T6
- University of Manitoba
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
70 år och äldre (Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Geriatric Depression Scale-SF score of 6 or more
- Montreal Cognitive Assessment score of 25 or less
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Behavioural
Participant-identified community based activity
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Occupational Performance Using the The Canadian Occupational Performance Measure (COPM) at 5 Months
Tidsram: 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.
|
Initial and 5 month follow up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS2)
Tidsram: Initial and 5 month follow-up
|
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.
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Initial and 5 month follow-up
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Jacquie Ripat, PhD, University of Manitoba
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2015
Primärt slutförande (Faktisk)
15 september 2017
Avslutad studie (Faktisk)
15 september 2017
Studieregistreringsdatum
Först inskickad
1 december 2015
Först inskickad som uppfyllde QC-kriterierna
4 december 2015
Första postat (Uppskatta)
7 december 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 oktober 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 oktober 2019
Senast verifierad
1 augusti 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- H2015:132
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .