Psycho-Social Well Being Following Stroke (PsychoStroke)

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Dialogue-based psychosocial rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 322
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dialogue-based psychosocial intervention; 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.	Behavioral: Dialogue-based psychosocial rehabilitation
No Intervention: Usual care Control group; Participants receive usual rehabilitation and care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Oslo University Hospital; Sykehuset Innlandet HF
• Investigators: Principal Investigator: Marit Kirkevold, Ed.D, University of Oslo

Publications and helpful links

General Publications

• Mangset M, Kitzmuller G, Evju AS, Angel S, Aadal L, Martinsen R, Bronken BA, Kvigne KJ, Bragstad LK, Hjelle EG, Sveen U, Kirkevold M. Perceived study-induced influence on the control group in a randomized controlled trial evaluating a complex intervention to promote psychosocial well-being after stroke: a process evaluation. Trials. 2021 Nov 27;22(1):850. doi: 10.1186/s13063-021-05765-w.
• Martinsen R, Kitzmuller G, Mangset M, Kvigne K, Evju AS, Bronken BA, Bragstad LK, Hjelle EG, Sveen U, Kirkevold M. Nurses' and occupational therapists' experiences of conducting a home-based psychosocial intervention following stroke: a qualitative process evaluation. BMC Health Serv Res. 2021 Aug 11;21(1):791. doi: 10.1186/s12913-021-06857-8.
• Bragstad LK, Lerdal A, Gay CL, Kirkevold M, Lee KA, Lindberg MF, Skogestad IJ, Hjelle EG, Sveen U, Kottorp A. Psychometric properties of a short version of Lee Fatigue Scale used as a generic PROM in persons with stroke or osteoarthritis: assessment using a Rasch analysis approach. Health Qual Life Outcomes. 2020 Jun 5;18(1):168. doi: 10.1186/s12955-020-01419-8.
• Hjelle EG, Bragstad LK, Zucknick M, Kirkevold M, Thommessen B, Sveen U. The General Health Questionnaire-28 (GHQ-28) as an outcome measurement in a randomized controlled trial in a Norwegian stroke population. BMC Psychol. 2019 Mar 22;7(1):18. doi: 10.1186/s40359-019-0293-0.
• Bragstad LK, Bronken BA, Sveen U, Hjelle EG, Kitzmuller G, Martinsen R, Kvigne KJ, Mangset M, Kirkevold M. Implementation fidelity in a complex intervention promoting psychosocial well-being following stroke: an explanatory sequential mixed methods study. BMC Med Res Methodol. 2019 Mar 15;19(1):59. doi: 10.1186/s12874-019-0694-z.
• Kirkevold M, Kildal Bragstad L, Bronken BA, Kvigne K, Martinsen R, Gabrielsen Hjelle E, Kitzmuller G, Mangset M, Angel S, Aadal L, Eriksen S, Wyller TB, Sveen U. Promoting psychosocial well-being following stroke: study protocol for a randomized, controlled trial. BMC Psychol. 2018 Apr 3;6(1):12. doi: 10.1186/s40359-018-0223-6.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 4, 2014
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Actual): March 6, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2013/2047