Clinical trial NCT02338869: Psycho-Social Well Being Following Stroke
Official title: Psycho-Social Well Being Following Stroke - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Sykehuset Innlandet HF
First posted: 2015-01-14
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: General Health Questionnaire (GHQ 28)
timeFrame: T2 (6 months poststroke)
Secondary outcomes:
measure: The Stroke and Aphasia Quality of Life scale (SAQOL-39)
timeFrame: T2 (6 months poststroke)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University hospital
Study officials:
affiliation: University of Oslo
name: Marit Kirkevold, Ed.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.