Psycho-Social Well Being Following Stroke (PsychoStroke)

University of Oslo

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Dialogue-based psychosocial rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02338869

2013/2047

Details and patient eligibility

About

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.

Enrollment: 322 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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322 participants in 2 patient groups

Dialogue-based psychosocial intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Dialogue-based psychosocial rehabilitation

Usual care Control group

No Intervention group

Description:

Participants receive usual rehabilitation and care.