Stroke - 65 Plus. Continued Active Life. (Stroke65+)

August 24, 2021 updated by: Hanne Pallesen, Central Jutland Regional Hospital

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

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'.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hammel, Denmark, 8450
        • Region Hospital Hammmel Neurorehabilitation
    • Jutland
      • Hammel, Jutland, Denmark, 8450
        • Region Hospital Hammel Neurocentre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: Mentor
Traditional rehabilitation.
Other Names:
  • Self-mangement
Active Comparator: 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
Behavioral: Mentor
Traditional rehabilitation.
Other Names:
  • Self-mangement

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity (accelerometers)
Time Frame: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Change of activity
Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Caregiver Burden Scale
Time Frame: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Change of caregivers burden
Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Jutland Regional Hospital

Investigators

  • Principal Investigator: Hanne Pallesen, Post Doc, Hammel neurorehabilitation centre and university research clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2017

Primary Completion (Actual)

November 15, 2020

Study Completion (Actual)

August 24, 2021

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JutlandRH54962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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