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Psycho-Social Well Being Following Stroke (PsychoStroke)

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ClinicalTrials.gov Identifier: NCT02338869
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
Oslo University Hospital
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Marit Kirkevold, 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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Dialogue-based psychosocial rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Psycho-Social Well Being Following Stroke - A Randomized Controlled Trial
Actual Study Start Date : December 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

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.



Primary Outcome Measures :
  1. General Health Questionnaire (GHQ 28) [ Time Frame: 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 :
  1. The Stroke and Aphasia Quality of Life scale (SAQOL-39) [ Time Frame: T2 (6 months poststroke) ]
    Disease-specific quality of life scale, measures patient's perspective of stroke's impact on 'physical', 'psychosocial' and 'communication' domains.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338869


Locations
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Norway
Oslo University hospital
Oslo, Norway
Sponsors and Collaborators
University of Oslo
Oslo University Hospital
Sykehuset Innlandet HF
Investigators
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Principal Investigator: Marit Kirkevold, Ed.D University of Oslo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marit Kirkevold, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT02338869     History of Changes
Other Study ID Numbers: 2013/2047
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases