Stroke - 65 Plus. Continued Active Life.

Quality of Life Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183960
• Other study ID #: JutlandRH54962
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: August 24, 2021

Study information

• Verified date: August 2021
• Source: Central Jutland Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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'.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 24, 2021
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life
• Self-management
• Stroke

Intervention

Behavioral:
• Mentor
Traditional rehabilitation.

Locations

Country	Name	City	State
Denmark	Region Hospital Hammel Neurocentre	Hammel	Jutland
Denmark	Region Hospital Hammmel Neurorehabilitation	Hammel

Sponsors (1)

Lead Sponsor	Collaborator
Central Jutland Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Activity (accelerometers)	Change of activity	Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Other	Caregiver Burden Scale	Change of caregivers burden	Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Primary	Stroke Self-efficacy questionnaire	Change of Self-efficacy	Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
Secondary	Impact on participation and Autonomy Questionnaire	Change of Impact on participation and Autonomy	Measured 3 and 9 months post discharged from rehabilitation hospital
Secondary	Stroke Specific Quality of Life Scale Questionnaire(short version)	Change of Specific Quality of Life	Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital