Psycho-Social Well Being Following Stroke - A Randomized Controlled Trial

University of Oslo1 site in 1 country322 target enrollmentDecember 2014

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: University of Oslo
Enrollment: 322
Locations: 1
Primary Endpoint: General Health Questionnaire (GHQ 28)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Multicenter randomized controlled trial (RCT) testing the effect of a dialogue-based psychosocial intervention for stroke acute survivors in primary care one to six months poststroke. Primary outcome is psycho-social health and wellbeing, measured by GHQ28 (primary outcome) and SAQoL (secondary outcome). 400 stroke survivors are randomized into intervention group or control group. Patients are followed up for 12 months.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

December 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Oslo

Responsible Party

Principal Investigator

Marit Kirkevold

Professor

University of Oslo

Eligibility Criteria

Inclusion Criteria

•being adults (over 18 years old),
•suffered an acute stroke within the last month,
•medically stable,
•sufficient cognitive functioning to participate (assessed by their physician/stroke team and acceptable Raven's score (see below),
•interested in participating,
•able to understand and speak Norwegian, and
•able to give informed consent.

Exclusion Criteria

•moderate to severe dementia or other serious disease.
•Persons with aphasia will be examined by a speech therapist and excluded if they have significant impressive aphasia or severe expressive aphasia inconsistent with participating in the dialogues.