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

Primary Purpose

Self-management, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Mentor
Sponsored by
Central Jutland Regional Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Self-management focused on measuring Self-management, Quality of Life, Self-efficacy, Support, Stroke, Older adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Region Hospital Hammel Neurocentre
  • Region Hospital Hammmel Neurorehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mentor

Traditional rehabilitation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Stroke Self-efficacy questionnaire
Change of Self-efficacy

Secondary Outcome Measures

Impact on participation and Autonomy Questionnaire
Change of Impact on participation and Autonomy
Stroke Specific Quality of Life Scale Questionnaire(short version)
Change of Specific Quality of Life

Full Information

First Posted
June 6, 2017
Last Updated
August 24, 2021
Sponsor
Central Jutland Regional Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03183960
Brief Title
Stroke - 65 Plus. Continued Active Life.
Acronym
Stroke65+
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
August 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Jutland Regional Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-management, Quality of Life
Keywords
Self-management, Quality of Life, Self-efficacy, Support, Stroke, Older adults

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mentor
Arm Type
Experimental
Arm Description
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
Arm Title
Traditional rehabilitation
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Mentor
Other Intervention Name(s)
Self-mangement
Intervention Description
Traditional rehabilitation.
Primary Outcome Measure Information:
Title
Stroke Self-efficacy questionnaire
Description
Change of Self-efficacy
Time Frame
Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Secondary Outcome Measure Information:
Title
Impact on participation and Autonomy Questionnaire
Description
Change of Impact on participation and Autonomy
Time Frame
Measured 3 and 9 months post discharged from rehabilitation hospital
Title
Stroke Specific Quality of Life Scale Questionnaire(short version)
Description
Change of Specific Quality of Life
Time Frame
Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Other Pre-specified Outcome Measures:
Title
Activity (accelerometers)
Description
Change of activity
Time Frame
Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Title
Caregiver Burden Scale
Description
Change of caregivers burden
Time Frame
Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne Pallesen, Post Doc
Organizational Affiliation
Hammel Neurorehabilitation Centre and University Research Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Hospital Hammel Neurocentre
City
Hammel
State/Province
Jutland
ZIP/Postal Code
8450
Country
Denmark
Facility Name
Region Hospital Hammmel Neurorehabilitation
City
Hammel
ZIP/Postal Code
8450
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34994306
Citation
Pedersen SKS, Pallesen H. Stroke self-efficacy questionnaire - Denmark (SSEQ-DK): test-retest of the Danish version. Top Stroke Rehabil. 2023 Mar;30(2):193-202. doi: 10.1080/10749357.2021.2016097. Epub 2022 Jan 7.
Results Reference
derived
PubMed Identifier
31113442
Citation
Sorensen SL, Pedersen SKS, Pallesen H. Social psychological mechanisms and processes in a novel, health professional-led, self-management intervention for older stroke individuals: a synthesis and phenomenological study. BMC Health Serv Res. 2019 May 22;19(1):320. doi: 10.1186/s12913-019-4150-x.
Results Reference
derived
PubMed Identifier
30454014
Citation
Pallesen H, Naess-Schmidt ET, Kjeldsen SS, Pedersen SKS, Sorensen SL, Brunner I, Nielsen JF. "Stroke - 65 Plus. Continued Active Life": a study protocol for a randomized controlled cross-sectoral trial of the effect of a novel self-management intervention to support elderly people after stroke. Trials. 2018 Nov 19;19(1):639. doi: 10.1186/s13063-018-2961-4.
Results Reference
derived

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Stroke - 65 Plus. Continued Active Life.

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