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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Hammel, Denemarken, 8450
- Region Hospital Hammmel Neurorehabilitation
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Jutland
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Hammel, Jutland, Denemarken, 8450
- Region Hospital Hammel Neurocentre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
Andere namen:
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Actieve vergelijker: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Stroke Self-efficacy questionnaire
Tijdsspanne: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Change of Self-efficacy
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Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Impact on participation and Autonomy Questionnaire
Tijdsspanne: Measured 3 and 9 months post discharged from rehabilitation hospital
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Change of Impact on participation and Autonomy
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Measured 3 and 9 months post discharged from rehabilitation hospital
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Stroke Specific Quality of Life Scale Questionnaire(short version)
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Activity (accelerometers)
Tijdsspanne: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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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
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Hanne Pallesen, Post Doc, Hammel neurorehabilitation centre and university research clinic
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- JutlandRH54962
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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