Psycho-Social Well Being Following Stroke

Stroke Clinical Trial

— PsychoStroke  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338869
• Other study ID #: 2013/2047
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Dialogue-based psychosocial rehabilitation

Locations

Country	Name	City	State
Norway	Oslo University hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Oslo University Hospital, Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General Health Questionnaire (GHQ 28)	28 item general scale measuring emotional distress. Four subscales (somatic symptoms, anxiety/insomnia, social dysfunction and serious depression	T2 (6 months poststroke)
Secondary	The Stroke and Aphasia Quality of Life scale (SAQOL-39)	Disease-specific quality of life scale, measures patient's perspective of stroke's impact on 'physical', 'psychosocial' and 'communication' domains.	T2 (6 months poststroke)