Psycho-Social Well Being Following Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Dialogue-based psychosocial rehabilitation

• Registration Number: NCT02338869
• Lead Sponsor: University of Oslo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-04
• Study Start: 2014-12
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-14
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dialogue-based psychosocial intervention	Dialogue-based psychosocial rehabilitation	Participants receive six individual meetings with trained health care professional in additional to usual rehabilitation and care. Dialogues focus on individual psychosocial challenges and needs and provide emotional and informational support to encourage and facilitate coping.

Primary Outcome Measures

Name	Time	Method
General Health Questionnaire (GHQ 28)	T2 (6 months poststroke)	28 item general scale measuring emotional distress. Four subscales (somatic symptoms, anxiety/insomnia, social dysfunction and serious depression

Secondary Outcome Measures

Name	Time	Method
The Stroke and Aphasia Quality of Life scale (SAQOL-39)	T2 (6 months poststroke)	Disease-specific quality of life scale, measures patient's perspective of stroke's impact on 'physical', 'psychosocial' and 'communication' domains.

Trial Locations

Locations (1)

Oslo University hospital; 🇳🇴 Oslo, Norway