- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02622828
Increasing the Winter Community Participation of Older Adult Wheelchair Users
2. oktober 2019 oppdatert 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
4
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E0T6
- University of Manitoba
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
70 år og eldre (Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Occupational Performance Using the The Canadian Occupational Performance Measure (COPM) at 5 Months
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS2)
Tidsramme: 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.
|
Initial and 5 month follow-up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Jacquie Ripat, PhD, University of Manitoba
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. desember 2015
Primær fullføring (Faktiske)
15. september 2017
Studiet fullført (Faktiske)
15. september 2017
Datoer for studieregistrering
Først innsendt
1. desember 2015
Først innsendt som oppfylte QC-kriteriene
4. desember 2015
Først lagt ut (Anslag)
7. desember 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. oktober 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. oktober 2019
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- H2015:132
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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