Stroke - 65 Plus. Continued Active Life.

Study Overview
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Brief Summary
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Since august 2016, the researchers at a highly specialized neurorehabilitation hospital in a Danish region with 1.2 inhabitants have in cooperation with health professionals from a specialized neurorehabilitation in a Danish municipality with 336,000 inhabitants, worked through and is still working with an iterative process in the development of a novel self-management support intervention for elderly stroke individuals.The intervention is going to be implemented into the second phase- a randomized clinical controlled trial (RCT) in the project named 'Stroke - 65 plus. Continued active life'.

Detailed Description
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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.

Official Title
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Stroke - 65 Plus. Continued Active Life. A Randomised Controlled Trial of the Effect of a Novel Self-management Intervention Supporting Older Adults After Stroke

Conditions
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Self-management, Quality of Life

Intervention / Treatment
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* Behavioral: Mentor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mentor<br>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 | Behavioral: Mentor<br>* Traditional rehabilitation.<br>* Other names: Self-mangement;|
| Active Comparator: Traditional rehabilitation<br>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 | Behavioral: Mentor<br>* Traditional rehabilitation.<br>* Other names: Self-mangement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Self-efficacy questionnaire | Change of Self-efficacy | Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on participation and Autonomy Questionnaire | Change of Impact on participation and Autonomy | Measured 3 and 9 months post discharged from rehabilitation hospital | 
| Stroke Specific Quality of Life Scale Questionnaire(short version) | Change of Specific Quality of Life | Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-management, Quality of Life, Self-efficacy, Support, Stroke, Older adults