A Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke (LAS-2)

April 14, 2013 updated by: Lena von Koch, Karolinska Institutet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perceived participation
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

The Swedish Research Council
Region Stockholm
Swedish Council for Working Life and Social Research
Uppsala County Council, Sweden
Uppsala-Örebro Regional Research Council
Stroke-Riksförbundet
The Swedish Brain Foundation (Hjärnfonden)

Investigators

  • Study Chair: Kerstin Tham, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (Estimate)

August 16, 2011

Study Record Updates

Last Update Posted (Estimate)

April 16, 2013

Last Update Submitted That Met QC Criteria

April 14, 2013

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/727-31/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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