Stroke - 65 Plus. Continued Active Life.

NCT03183960 | Completed

• 1 other identifier: JutlandRH54962
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

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'.

Conditions

Self-management; Quality of Life

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Stroke Self-efficacy questionnaire

  Change of Self-efficacy

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

Secondary Outcomes (2)

• Impact on participation and Autonomy Questionnaire

  Measured 3 and 9 months post discharged from rehabilitation hospital

• Stroke Specific Quality of Life Scale Questionnaire(short version)

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

Other Outcomes (2)

• Activity (accelerometers)

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

• Caregiver Burden Scale

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

Study Arms (2)

Mentor

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Interventions

Mentor BEHAVIORAL

Traditional rehabilitation.

Also known as: Self-mangement

Mentor; Traditional rehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• stroke survivors with rehabilitation needs discharge from rehabilitation hospital to home

You may not qualify if:

• do not understand danish Montreal Cognitive assessment (MOCA) below 20

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead

Study Sites (2)

Region Hospital Hammel Neurocentre

Hammel, Jutland, 8450, Denmark

Location

Region Hospital Hammmel Neurorehabilitation

Hammel, 8450, Denmark

Location

Related Publications (4)

• Pallesen H, Pedersen SKS, Sorensen SL, Naess-Schmidt ET, Brunner I, Nielsen JF, Kjeldsen SS. "Stroke - 65 plus. Continued active life." A randomized controlled trial of a self-management neurorehabilitation intervention for elderly people after stroke. Disabil Rehabil. 2025 Jan;47(1):104-113. doi: 10.1080/09638288.2024.2338190. Epub 2024 Apr 8.

  PMID: 38587056 DERIVED

• 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.

  PMID: 34994306 DERIVED

• 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.

  PMID: 31113442 DERIVED

• 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.

  PMID: 30454014 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hanne Pallesen, Post Doc

  Hammel Neurorehabilitation Centre and University Research Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD. Head of Clinical Physiotherapy Research, at Hammel Neurorehabilitation Centre and University Research Clinic, Hammel, Denmark

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 12, 2017
• Study Start: June 15, 2017
• Primary Completion: November 15, 2020
• Study Completion: August 24, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)