A Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke

Not Applicable

Completed

• Conditions: Stroke; Physical Disability; Multiple Disability

• Registration Number: NCT01417585
• Lead Sponsor: Karolinska Institutet

Brief Summary

This is a cluster randomized controlled trial in which client-centered rehabilitation of activities of daily living (CADL) will be compared to usual rehabilitation of activities of daily living (UADL) regarding participation in activities of daily living, independence in activities of daily living and life satisfaction during the first year after stroke. In addition use of health services, caregiver burden and significant others' life satisfaction will be studied. Study design, methods and power analysis are based on our previous pilot study. Participating rehabilitation centers in the counties of Stockholm, Uppsala and Gavleborg have been randomized to supply CADL or UADL. Patients are included who are: \< 3 months after stroke, dependent in at least two activities of daily living, understand instructions and referred to a participating rehabilitation unit. Data are collected at baseline, 3, 6 and 12 months. For sufficient power 280 participants will be included. In addition qualitative longitudinal studies will be performed in order to describe how CADL is integrated.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Status Verified: 2012-01
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Last Update Submitted: 2013-04-14
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• < 3 months after stroke
• Dependent in at least two activities of daily living
• Able to understand instructions
• Referred to a participating rehabilitation unit.

Exclusion Criteria

• Diagnosed dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perceived participation	12 months

Secondary Outcome Measures

Name	Time	Method
Life satisfaction	3 and 12 months
Utilization of health care and health related services	During one year after inclusion
Fatigue	baseline, 3, 6 and 12 months
Caregiver burden	3 and 12 months
Self rated impact of stroke	3, 6 and 12 months	Stroke Impact Scale
Activities of daily living	baseline, 3, 6 and 12 months
Satisfaction with care	3, 6 and 12 months

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden