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

Primary Purpose

Stroke, Physical Disability, Multiple Disability

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Client-centered ADL intervention
Usual ADL intervention
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Activities of daily living, Caregiver burden, Client centered, Life satisfaction, Participation, Patient satisfaction, Rehabilitation, Self rated impact of stroke, Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet

Outcomes

Primary Outcome Measures

Perceived participation

Secondary Outcome Measures

Life satisfaction
Utilization of health care and health related services
Fatigue
Caregiver burden
Self rated impact of stroke
Stroke Impact Scale
Activities of daily living
Satisfaction with care

Full Information

First Posted
August 15, 2011
Last Updated
April 14, 2013
Sponsor
Karolinska Institutet
Collaborators
The Swedish Research Council, Swedish Council for Working Life and Social Research, The Swedish Brain Foundation (Hjärnfonden), Stroke-Riksförbundet, Region Stockholm, Uppsala County Council, Sweden, Uppsala-Örebro Regional Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT01417585
Brief Title
A Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke
Acronym
LAS-2
Official Title
A Randomized Controlled Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
The Swedish Research Council, Swedish Council for Working Life and Social Research, The Swedish Brain Foundation (Hjärnfonden), Stroke-Riksförbundet, Region Stockholm, Uppsala County Council, Sweden, Uppsala-Örebro Regional Research Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Physical Disability, Multiple Disability
Keywords
Activities of daily living, Caregiver burden, Client centered, Life satisfaction, Participation, Patient satisfaction, Rehabilitation, Self rated impact of stroke, Stroke

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Client-centered ADL intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual ADL intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceived participation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Life satisfaction
Time Frame
3 and 12 months
Title
Utilization of health care and health related services
Time Frame
During one year after inclusion
Title
Fatigue
Time Frame
baseline, 3, 6 and 12 months
Title
Caregiver burden
Time Frame
3 and 12 months
Title
Self rated impact of stroke
Description
Stroke Impact Scale
Time Frame
3, 6 and 12 months
Title
Activities of daily living
Time Frame
baseline, 3, 6 and 12 months
Title
Satisfaction with care
Time Frame
3, 6 and 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerstin Tham, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Chair
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
30082359
Citation
Tistad M, Flink M, Ytterberg C, Eriksson G, Guidetti S, Tham K, von Koch L. Resource use of healthcare services 1 year after stroke: a secondary analysis of a cluster-randomised controlled trial of a client-centred activities of daily living intervention. BMJ Open. 2018 Aug 5;8(8):e022222. doi: 10.1136/bmjopen-2018-022222.
Results Reference
derived

Learn more about this trial

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

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