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

This study has been completed.
Sponsor:
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
The Doctoral School in Health Care Sciences at Karolinska Institutet
Uppsala-Örebro Regional Research Council
Information provided by (Responsible Party):
Lena von Koch, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01417585
First received: August 15, 2011
Last updated: April 14, 2013
Last verified: January 2012
  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 Blind (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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Perceived participation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Life satisfaction [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Utilization of health care and health related services [ Time Frame: During one year after inclusion ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Caregiver burden [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Self rated impact of stroke [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Stroke Impact Scale

  • Activities of daily living [ Time Frame: baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Satisfaction with care [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
The Doctoral School in Health Care Sciences at Karolinska Institutet
Uppsala-Örebro Regional Research Council
Investigators
Study Chair: Kerstin Tham, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Lena von Koch, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01417585     History of Changes
Other Study ID Numbers: 2009/727-31/1
Study First Received: August 15, 2011
Last Updated: April 14, 2013
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Research Council

Keywords provided by 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
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 30, 2014