- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 navn:
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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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Stroke Self-efficacy questionnaire
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Impact on participation and Autonomy Questionnaire
Tidsramme: 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)
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Activity (accelerometers)
Tidsramme: 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
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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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Hanne Pallesen, Post Doc, Hammel neurorehabilitation centre and university research clinic
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- JutlandRH54962
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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