- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03183960
Stroke - 65 Plus. Continued Active Life. (Stroke65+)
Stroke - 65 Plus. Continued Active Life. A Randomised Controlled Trial of the Effect of a Novel Self-management Intervention Supporting Older Adults After Stroke
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background: Elderly adults represent the majority of stroke cases worldwide. Sequelae after a stroke causes the stroke individuals to live a more isolated life 5 years after the stroke. This makes the stroke individuals an especially vulnerable group of elderly people regarding social reintegration. Reintegration into the community post-stroke depends highly on support from the family. However, the stroke individual's closest relatives are at risk of developing anxiety and depression.
The aim of this study is to investigate the effect of a novel self-management intervention supporting older adults after stroke
Methods/Design: Randomized controlled observer-blind trial. More than sixty stroke survivors over 65 years will two weeks before leaving a rehabilitation hospital be randomized to either a group receiving conventional rehabilitation (control) or a novel self-management intervention addition to standard rehabilitation.
During a period of 6 months the patients will be offered additional 6-8 sessions of self-management intervention of 45-60 minutes duration by a physiotherapist or an occupational therapist.
Study outcome measurements: Stroke Self-efficacy questionnaire, Stroke Specific Quality of Life Scale and Impact on participation and Autonomy and activity by accelerometers will be evaluated at baseline, three and nine months post hospital treatment.
Patient, informal caregiver and therapist satisfaction will be with examined with questionnaires and interviews.
Discussion: Self-management interventions are promising tools for rehabilitation of self-efficacy, quality of life as well as participation and autonomy. The introduction of novel self management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke, quality of life and burden on relatives. Stroke 65+ trial will provide further evidence of self management strategies to clinicians, patients and health economists.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Hammel, Danmark, 8450
- Region Hospital Hammmel Neurorehabilitation
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Jutland
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Hammel, Jutland, Danmark, 8450
- Region Hospital Hammel Neurocentre
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- stroke survivors with rehabilitation needs discharge from rehabilitation hospital to home
Exclusion Criteria:
- do not understand danish Montreal Cognitive assessment (MOCA) below 20
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Mentor
An independent centralized randomization database will provide allocation concealed to the involved clinicians and assessors.
A stratified block randomization of severity of impairment will be performed within each rehabilitation hospital
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Traditional rehabilitation.
Andre navne:
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|
Aktiv komparator: Traditional rehabilitation
An independent centralized randomization database will provide allocation concealed to the involved clinicians and assessors.
A stratified block randomization of severity of impairment will be performed within each rehabilitation hospital
|
Traditional rehabilitation.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Stroke Self-efficacy questionnaire
Tidsramme: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
|
Change of Self-efficacy
|
Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Impact on participation and Autonomy Questionnaire
Tidsramme: Measured 3 and 9 months post discharged from rehabilitation hospital
|
Change of Impact on participation and Autonomy
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Measured 3 and 9 months post discharged from rehabilitation hospital
|
|
Stroke Specific Quality of Life Scale Questionnaire(short version)
Tidsramme: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Change of Specific Quality of Life
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Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Activity (accelerometers)
Tidsramme: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
|
Change of activity
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Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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|
Caregiver Burden Scale
Tidsramme: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Change of caregivers burden
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Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Hanne Pallesen, Post Doc, Hammel neurorehabilitation centre and university research clinic
Publikationer og nyttige links
Generelle publikationer
- Pedersen SKS, Pallesen H. Stroke self-efficacy questionnaire - Denmark (SSEQ-DK): test-retest of the Danish version. Top Stroke Rehabil. 2023 Mar;30(2):193-202. doi: 10.1080/10749357.2021.2016097. Epub 2022 Jan 7.
- Sorensen SL, Pedersen SKS, Pallesen H. Social psychological mechanisms and processes in a novel, health professional-led, self-management intervention for older stroke individuals: a synthesis and phenomenological study. BMC Health Serv Res. 2019 May 22;19(1):320. doi: 10.1186/s12913-019-4150-x.
- Pallesen H, Naess-Schmidt ET, Kjeldsen SS, Pedersen SKS, Sorensen SL, Brunner I, Nielsen JF. "Stroke - 65 Plus. Continued Active Life": a study protocol for a randomized controlled cross-sectoral trial of the effect of a novel self-management intervention to support elderly people after stroke. Trials. 2018 Nov 19;19(1):639. doi: 10.1186/s13063-018-2961-4.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- JutlandRH54962
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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