Clinical trial NCT03183960: Stroke - 65 Plus. Continued Active Life.
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
Overall status: COMPLETED
Phase: NA
Conditions: Self-management
Quality of Life
Keywords: Self-management
Quality of Life
Self-efficacy
Support
Stroke
Older adults
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Stroke Self-efficacy questionnaire
timeFrame: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Secondary outcomes:
measure: Impact on participation and Autonomy Questionnaire
timeFrame: Measured 3 and 9 months post discharged from rehabilitation hospital
measure: Stroke Specific Quality of Life Scale Questionnaire(short version)
timeFrame: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Other outcomes:
measure: Activity (accelerometers)
timeFrame: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
measure: Caregiver Burden Scale
timeFrame: Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Locations:
city: Hammel
country: Denmark
facility: Region Hospital Hammel Neurocentre
state: Jutland
city: Hammel
country: Denmark
facility: Region Hospital Hammmel Neurorehabilitation
Study officials:
affiliation: Hammel Neurorehabilitation Centre and University Research Clinic
name: Hanne Pallesen, Post Doc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.