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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Physical Disability, Multiple Disability

Intervention / Treatment
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* Behavioral: Client-centered ADL intervention
* Behavioral: Usual ADL intervention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived participation |  | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Activities of daily living, Caregiver burden, Client centered, Life satisfaction, Participation, Patient satisfaction, Rehabilitation, Self rated impact of stroke