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Completed

NCT Number: NCT01417585

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

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.

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Key information

Conditions

Stroke Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Caregiver Burden Central Nervous System Diseases Cerebrovascular Disorders Health Behavior Multiple Disability Nervous System Diseases Patient Satisfaction Personal Satisfaction Physical Disability Stress, Psychological Treatment Adherence and Compliance Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Client-centered ADL intervention

Behavioral

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

Behavioral

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 outcomes

  1. Perceived participation

    Time frame: 12 months

Secondary outcomes

  1. Life satisfaction

    Time frame: 3 and 12 months

  2. Utilization of health care and health related services

    Time frame: During one year after inclusion

  3. Fatigue

    Time frame: baseline, 3, 6 and 12 months

  4. Caregiver burden

    Time frame: 3 and 12 months

  5. Self rated impact of stroke

    Time frame: 3, 6 and 12 months

    Stroke Impact Scale

  6. Activities of daily living

    Time frame: baseline, 3, 6 and 12 months

  7. Satisfaction with care

    Time frame: 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm
  • Stroke-Riksförbundet
  • Swedish Council for Working Life and Social Research
  • The Swedish Brain Foundation (Hjärnfonden)
  • The Swedish Research Council
  • Uppsala County Council, Sweden
  • Uppsala-Örebro Regional Research Council

Registry information

Official study title

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

Acronym: LAS-2

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 16, 2011
Registry last updated
Apr 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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