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

NCT ID: NCT01417585

Last Updated: 2013-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Stroke Physical Disability Multiple Disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Swedish Council for Working Life and Social Research

OTHER

Sponsor Role collaborator

The Swedish Brain Foundation (Hjärnfonden)

UNKNOWN

Sponsor Role collaborator

Stroke-Riksförbundet

UNKNOWN

Sponsor Role collaborator

Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Uppsala County Council, Sweden

OTHER_GOV

Sponsor Role collaborator

Uppsala-Örebro Regional Research Council

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Lena von Koch

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kerstin Tham, PhD

Role: STUDY_CHAIR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 30082359 (View on PubMed)

Other Identifiers

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2009/727-31/1

Identifier Type: -

Identifier Source: org_study_id

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