Clinical trial NCT01417585: A Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke
Official title: A Randomized Controlled Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Swedish Council for Working Life and Social Research
name: The Swedish Brain Foundation (Hjärnfonden)
name: Stroke-Riksförbundet
name: Region Stockholm
name: Uppsala County Council, Sweden
name: Uppsala-Örebro Regional Research Council
First posted: 2011-08-16
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Perceived participation
timeFrame: 12 months
Secondary outcomes:
measure: Life satisfaction
timeFrame: 3 and 12 months
measure: Utilization of health care and health related services
timeFrame: During one year after inclusion
measure: Fatigue
timeFrame: baseline, 3, 6 and 12 months
measure: Caregiver burden
timeFrame: 3 and 12 months
measure: Self rated impact of stroke
timeFrame: 3, 6 and 12 months
measure: Activities of daily living
timeFrame: baseline, 3, 6 and 12 months
measure: Satisfaction with care
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Kerstin Tham, PhD
role: STUDY_CHAIR
References:
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.