Psycho-Social Well Being Following Stroke

NCT02338869 | Completed DMC

• 1 other identifier: 2013/2047
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Stroke and Aphasia Quality of Life scale (SAQOL-39)

  T2 (6 months poststroke)

Study Arms (2)

Dialogue-based psychosocial intervention

EXPERIMENTAL

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

Usual care Control group

NO INTERVENTION

Participants receive usual rehabilitation and care.

Interventions

Dialogue-based psychosocial rehabilitation BEHAVIORAL

Dialogue-based psychosocial intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oslo: lead
• Oslo University Hospital: collaborator
• Sykehuset Innlandet HF: collaborator

Study Sites (1)

Oslo University hospital

Oslo, Norway

Location

Related Publications (6)

• 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.

  PMID: 34838094 DERIVED

• 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.

  PMID: 34376188 DERIVED

• 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.

  PMID: 32503548 DERIVED

• 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.

  PMID: 30902115 DERIVED

• 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.

  PMID: 30876403 DERIVED

• 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.

  PMID: 29615136 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marit Kirkevold, Ed.D

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2014
• First Posted: January 14, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

NO (1)