NCT01417585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 16, 2013

Status Verified

January 1, 2012

Enrollment Period

3 years

First QC Date

August 15, 2011

Last Update Submit

April 14, 2013

Conditions

StrokePhysical DisabilityMultiple Disability

Keywords

Activities of daily livingCaregiver burdenClient centeredLife satisfactionParticipationPatient satisfactionRehabilitationSelf rated impact of strokeStroke

Outcome Measures

Primary Outcomes (1)

  • Perceived participation

    12 months

Secondary Outcomes (7)

  • 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

    3, 6 and 12 months

  • +2 more secondary outcomes

Interventions

Client-centered ADL interventionBEHAVIORAL

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 interventionBEHAVIORAL

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \< 3 months after stroke
  • Dependent in at least two activities of daily living
  • Able to understand instructions
  • Referred to a participating rehabilitation unit.

You may not qualify if:

  • Diagnosed dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 30082359DERIVED

MeSH Terms

Conditions

StrokeCaregiver BurdenPersonal SatisfactionPatient Satisfaction

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesStress, PsychologicalBehavioral SymptomsBehaviorTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Kerstin Tham, PhD

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2011

First Posted

August 16, 2011

Study Start

September 1, 2009

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

April 16, 2013

Record last verified: 2012-01

Locations

SE(1)