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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417585
First Posted: August 16, 2011
Last Update Posted: April 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Swedish Research Council
Swedish Council for Working Life and Social Research
The Swedish Brain Foundation (Hjärnfonden)
Stroke-Riksförbundet
Stockholm County Council, Sweden
Uppsala County Council, Sweden
Uppsala-Örebro Regional Research Council
Information provided by (Responsible Party):
Lena von Koch, Karolinska Institutet
  Purpose
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.

Condition Intervention
Stroke Physical Disability Multiple Disability Behavioral: Client-centered ADL intervention Behavioral: Usual ADL intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke

Further study details as provided by Lena von Koch, Karolinska Institutet:

Primary Outcome Measures:
  • Perceived participation [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Life satisfaction [ Time Frame: 3 and 12 months ]
  • Utilization of health care and health related services [ Time Frame: During one year after inclusion ]
  • Fatigue [ Time Frame: baseline, 3, 6 and 12 months ]
  • Caregiver burden [ Time Frame: 3 and 12 months ]
  • Self rated impact of stroke [ Time Frame: 3, 6 and 12 months ]
    Stroke Impact Scale

  • Activities of daily living [ Time Frame: baseline, 3, 6 and 12 months ]
  • Satisfaction with care [ Time Frame: 3, 6 and 12 months ]

Enrollment: 280
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Client-centered ADL intervention
    Client-centered ADL refers to rehabilitation of activities of daily living specifically guided by the needs as expressed by the client/patient and her/his significant others, a process that specifically aims to support the client by taking the client's goals and views as the guide for the rehabilitation process.
    Behavioral: Usual ADL intervention
    The variation of strategies and ways to conduct usual ADL rehabilitation according to the routines and praxis of the participating rehabilitation units randomized to supply the control condition.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417585


Locations
Sweden
Karolinska Institutet
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Swedish Council for Working Life and Social Research
The Swedish Brain Foundation (Hjärnfonden)
Stroke-Riksförbundet
Stockholm County Council, Sweden
Uppsala County Council, Sweden
Uppsala-Örebro Regional Research Council
Investigators
Study Chair: Kerstin Tham, PhD Karolinska Institutet
  More Information

Responsible Party: Lena von Koch, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01417585     History of Changes
Other Study ID Numbers: 2009/727-31/1
First Submitted: August 15, 2011
First Posted: August 16, 2011
Last Update Posted: April 16, 2013
Last Verified: January 2012

Keywords provided by Lena von Koch, Karolinska Institutet:
Activities of daily living
Caregiver burden
Client centered
Life satisfaction
Participation
Patient satisfaction
Rehabilitation
Self rated impact of stroke
Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases