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Stroke - 65 Plus. Continued Active Life.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03183960
Acronym
Stroke65+
Enrollment
69
Registered
2017-06-12
Start date
2017-06-15
Completion date
2021-08-24
Last updated
2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self-management, Quality of Life

Keywords

Self-management, Quality of Life, Self-efficacy, Support, Stroke, Older adults

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. 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.

Interventions

BEHAVIORALMentor

Traditional rehabilitation.

Sponsors

Central Jutland Regional Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Stroke Self-efficacy questionnaireMeasured at baseline, 3 and 9 months post discharged from rehabilitation hospitalChange of Self-efficacy

Secondary

MeasureTime frameDescription
Impact on participation and Autonomy QuestionnaireMeasured 3 and 9 months post discharged from rehabilitation hospitalChange of Impact on participation and Autonomy
Stroke Specific Quality of Life Scale Questionnaire(short version)Measured at baseline, 3 and 9 months post discharged from rehabilitation hospitalChange of Specific Quality of Life

Other

MeasureTime frameDescription
Activity (accelerometers)Measured at baseline, 3 and 9 months post discharged from rehabilitation hospitalChange of activity
Caregiver Burden ScaleMeasured at baseline, 3 and 9 months post discharged from rehabilitation hospitalChange of caregivers burden

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026