Stroke - 65 Plus. Continued Active Life. A Randomised Controlled Trial of the Effect of a Novel Self-management Intervention Supporting Older Adults After Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 69
- Locations
- 2
- Primary Endpoint
- Stroke Self-efficacy questionnaire
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Mentor (Behavioral)
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
Intervention: Mentor (Behavioral)
Outcomes
Primary Outcomes
Stroke Self-efficacy questionnaire
Time Frame: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Change of Self-efficacy
Secondary Outcomes
- Stroke Specific Quality of Life Scale Questionnaire(short version)(Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital)
- Impact on participation and Autonomy Questionnaire(Measured 3 and 9 months post discharged from rehabilitation hospital)
Investigators
Hanne Pallesen
Physiotherapist, PhD. Head of Clinical Physiotherapy Research, at Hammel Neurorehabilitation Centre and University Research Clinic, Hammel, Denmark
Central Jutland Regional Hospital