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

Stroke Clinical Trial

— LAS-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417585
• Other study ID #: 2009/727-31/1
• Status: Completed
• Phase: N/A
• First received: August 15, 2011
• Last updated: April 14, 2013
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2012
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Multiple Disability
• Physical Disability
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (9)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden, Stroke-Riksförbundet, Swedish Council for Working Life and Social Research, The Doctoral School in Health Care Sciences at Karolinska Institutet, The Swedish Brain Foundation (Hjärnfonden), The Swedish Research Council, Uppsala County Council, Sweden, Uppsala-Örebro Regional Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived participation		12 months	No
Secondary	Life satisfaction		3 and 12 months	No
Secondary	Utilization of health care and health related services		During one year after inclusion	No
Secondary	Fatigue		baseline, 3, 6 and 12 months	No
Secondary	Caregiver burden		3 and 12 months	No
Secondary	Self rated impact of stroke	Stroke Impact Scale	3, 6 and 12 months	No
Secondary	Activities of daily living		baseline, 3, 6 and 12 months	No
Secondary	Satisfaction with care		3, 6 and 12 months	No