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Psycho-Social Well Being Following Stroke (PsychoStroke)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Dialogue-based psychosocial rehabilitation
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Oslo University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dialogue-based psychosocial intervention

Usual care Control group

Arm 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.

Participants receive usual rehabilitation and care.

Outcomes

Primary Outcome Measures

General Health Questionnaire (GHQ 28)
28 item general scale measuring emotional distress. Four subscales (somatic symptoms, anxiety/insomnia, social dysfunction and serious depression

Secondary Outcome Measures

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.

Full Information

First Posted
October 4, 2014
Last Updated
March 5, 2019
Sponsor
University of Oslo
Collaborators
Oslo University Hospital, Sykehuset Innlandet HF
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1. Study Identification

Unique Protocol Identification Number
NCT02338869
Brief Title
Psycho-Social Well Being Following Stroke
Acronym
PsychoStroke
Official Title
Psycho-Social Well Being Following Stroke - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Oslo University Hospital, Sykehuset Innlandet HF

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialogue-based psychosocial intervention
Arm Type
Experimental
Arm 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.
Arm Title
Usual care Control group
Arm Type
No Intervention
Arm Description
Participants receive usual rehabilitation and care.
Intervention Type
Behavioral
Intervention Name(s)
Dialogue-based psychosocial rehabilitation
Primary Outcome Measure Information:
Title
General Health Questionnaire (GHQ 28)
Description
28 item general scale measuring emotional distress. Four subscales (somatic symptoms, anxiety/insomnia, social dysfunction and serious depression
Time Frame
T2 (6 months poststroke)
Secondary Outcome Measure Information:
Title
The Stroke and Aphasia Quality of Life scale (SAQOL-39)
Description
Disease-specific quality of life scale, measures patient's perspective of stroke's impact on 'physical', 'psychosocial' and 'communication' domains.
Time Frame
T2 (6 months poststroke)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marit Kirkevold, Ed.D
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
34838094
Citation
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.
Results Reference
derived
PubMed Identifier
34376188
Citation
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.
Results Reference
derived
PubMed Identifier
32503548
Citation
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.
Results Reference
derived
PubMed Identifier
30902115
Citation
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.
Results Reference
derived
PubMed Identifier
30876403
Citation
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.
Results Reference
derived
PubMed Identifier
29615136
Citation
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.
Results Reference
derived

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Psycho-Social Well Being Following Stroke

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