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“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

BACKGROUND: Elderly people represent the majority of stroke cases worldwide. Post-stroke sequelae frequently lead to a more isolated life. Restricted social relations render older individuals with stroke a vulnerable group, especially in terms of social reintegration. Reintegration into the communit...

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Autores principales: Pallesen, Hanne, Næss-Schmidt, Erhard Trillingsgaard, Kjeldsen, Simon Svanborg, Pedersen, Sedsel Kristine Stage, Sørensen, Susanne Lillelund, Brunner, Iris, Nielsen, Jørgen Feldbæk
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6245630/
https://www.ncbi.nlm.nih.gov/pubmed/30454014
http://dx.doi.org/10.1186/s13063-018-2961-4
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author Pallesen, Hanne
Næss-Schmidt, Erhard Trillingsgaard
Kjeldsen, Simon Svanborg
Pedersen, Sedsel Kristine Stage
Sørensen, Susanne Lillelund
Brunner, Iris
Nielsen, Jørgen Feldbæk
author_facet Pallesen, Hanne
Næss-Schmidt, Erhard Trillingsgaard
Kjeldsen, Simon Svanborg
Pedersen, Sedsel Kristine Stage
Sørensen, Susanne Lillelund
Brunner, Iris
Nielsen, Jørgen Feldbæk
author_sort Pallesen, Hanne
collection PubMed
description BACKGROUND: Elderly people represent the majority of stroke cases worldwide. Post-stroke sequelae frequently lead to a more isolated life. Restricted social relations render older individuals with stroke a vulnerable group, especially in terms of social reintegration. Reintegration into the community after a stroke largely depends on support from the family. However, close relatives are at risk of becoming overburdened. The aim of this study is to investigate the effect of a novel self-management intervention to support elderly people after stroke. METHODS/DESIGN: Randomized controlled trial. Two weeks before discharge from a rehabilitation hospital/center, individuals with stroke aged > 65 years will be randomized either to a group receiving conventional neurorehabilitation (control) or to an additional novel self-management intervention. In the intervention group, patients with stroke will be offered eight self-management sessions of 45–60 min duration by a physiotherapist or an occupational therapist during a period of nine months after discharge. Inclusion will continue until at least 35 individuals in each group have been recruited. Study outcome measurements: Stroke Self-efficacy Questionnaire, a short version of Stroke Specific Quality of Life Scale, Impact on Participation and Autonomy and Caregiver Burden Scale. Furthermore, physical activity will be assessed using accelerometers. All outcomes except “impact on participation” and “autonomy” will be assessed at baseline, three months, and nine months after discharge. Impact on participation and autonomy will be assessed at three and nine months after discharge. Patient, informal caregiver, and therapist satisfaction will be examined by way of questionnaires and interviews. DISCUSSION: Self-management interventions are promising strategies for rehabilitation, potentially increasing self-efficacy, quality of life, as well as participation and autonomy. The introduction of a novel self-management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke and quality of life and lessen the burden on relatives. This trial “Stroke - 65 Plus. Continued Active Life,” will provide further evidence of self-management strategies to clinicians, patients, and health economists. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03183960. Registered on 12 June 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2961-4) contains supplementary material, which is available to authorized users.
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spelling pubmed-62456302018-11-26 “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 Pallesen, Hanne Næss-Schmidt, Erhard Trillingsgaard Kjeldsen, Simon Svanborg Pedersen, Sedsel Kristine Stage Sørensen, Susanne Lillelund Brunner, Iris Nielsen, Jørgen Feldbæk Trials Study Protocol BACKGROUND: Elderly people represent the majority of stroke cases worldwide. Post-stroke sequelae frequently lead to a more isolated life. Restricted social relations render older individuals with stroke a vulnerable group, especially in terms of social reintegration. Reintegration into the community after a stroke largely depends on support from the family. However, close relatives are at risk of becoming overburdened. The aim of this study is to investigate the effect of a novel self-management intervention to support elderly people after stroke. METHODS/DESIGN: Randomized controlled trial. Two weeks before discharge from a rehabilitation hospital/center, individuals with stroke aged > 65 years will be randomized either to a group receiving conventional neurorehabilitation (control) or to an additional novel self-management intervention. In the intervention group, patients with stroke will be offered eight self-management sessions of 45–60 min duration by a physiotherapist or an occupational therapist during a period of nine months after discharge. Inclusion will continue until at least 35 individuals in each group have been recruited. Study outcome measurements: Stroke Self-efficacy Questionnaire, a short version of Stroke Specific Quality of Life Scale, Impact on Participation and Autonomy and Caregiver Burden Scale. Furthermore, physical activity will be assessed using accelerometers. All outcomes except “impact on participation” and “autonomy” will be assessed at baseline, three months, and nine months after discharge. Impact on participation and autonomy will be assessed at three and nine months after discharge. Patient, informal caregiver, and therapist satisfaction will be examined by way of questionnaires and interviews. DISCUSSION: Self-management interventions are promising strategies for rehabilitation, potentially increasing self-efficacy, quality of life, as well as participation and autonomy. The introduction of a novel self-management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke and quality of life and lessen the burden on relatives. This trial “Stroke - 65 Plus. Continued Active Life,” will provide further evidence of self-management strategies to clinicians, patients, and health economists. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03183960. Registered on 12 June 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2961-4) contains supplementary material, which is available to authorized users. BioMed Central 2018-11-19 /pmc/articles/PMC6245630/ /pubmed/30454014 http://dx.doi.org/10.1186/s13063-018-2961-4 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Pallesen, Hanne
Næss-Schmidt, Erhard Trillingsgaard
Kjeldsen, Simon Svanborg
Pedersen, Sedsel Kristine Stage
Sørensen, Susanne Lillelund
Brunner, Iris
Nielsen, Jørgen Feldbæk
“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
title “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
title_full “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
title_fullStr “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
title_full_unstemmed “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
title_short “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
title_sort “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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6245630/
https://www.ncbi.nlm.nih.gov/pubmed/30454014
http://dx.doi.org/10.1186/s13063-018-2961-4
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