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Completed

NCT Number: NCT03183960

Stroke - 65 Plus. Continued Active Life.

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'.

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Key information

Conditions

Self-management Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Quality of Life Stroke Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Hospital Hammel Neurocentre, Hammel, Jutland, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mentor

Behavioral

Traditional rehabilitation.

Other names: Self-mangement

Primary outcomes

  1. Stroke Self-efficacy questionnaire

    Time frame: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital

    Change of Self-efficacy

Secondary outcomes

  1. Impact on participation and Autonomy Questionnaire

    Time frame: Measured 3 and 9 months post discharged from rehabilitation hospital

    Change of Impact on participation and Autonomy

  2. Stroke Specific Quality of Life Scale Questionnaire(short version)

    Time frame: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital

    Change of Specific Quality of Life

Other outcomes

  1. Activity (accelerometers)

    Time frame: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital

    Change of activity

  2. Caregiver Burden Scale

    Time frame: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital

    Change of caregivers burden

Sponsors and collaborators

Lead sponsor

Central Jutland Regional Hospital

Other

Registry information

Official study title

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

Acronym: Stroke65+

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jun 12, 2017
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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