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Clinical Trials/NCT01417585
NCT01417585
Completed
Not Applicable

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

Karolinska Institutet1 site in 1 country280 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Karolinska Institutet
Enrollment
280
Locations
1
Primary Endpoint
Perceived participation
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lena von Koch

Professor

Karolinska Institutet

Eligibility Criteria

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

Outcomes

Primary Outcomes

Perceived participation

Time Frame: 12 months

Secondary Outcomes

  • 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)
  • Activities of daily living(baseline, 3, 6 and 12 months)
  • Satisfaction with care(3, 6 and 12 months)

Study Sites (1)

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