Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
322 participants
INTERVENTIONAL
2014-12-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Dialogue-based psychosocial rehabilitation
Usual care Control group
Participants receive usual rehabilitation and care.
No interventions assigned to this group
Interventions
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Dialogue-based psychosocial rehabilitation
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Sykehuset Innlandet HF
OTHER
University of Oslo
OTHER
Responsible Party
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Marit Kirkevold
Professor
Principal Investigators
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Marit Kirkevold, Ed.D
Role: PRINCIPAL_INVESTIGATOR
University of Oslo
Locations
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Oslo University hospital
Oslo, , Norway
Countries
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References
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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.
Other Identifiers
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2013/2047
Identifier Type: -
Identifier Source: org_study_id
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