Psychosocial Wellbeing Following Stroke

Sponsor
University of Oslo (Other)
Overall Status
Completed
CT.gov ID
NCT01912014
Collaborator
(none)
25
1
1
59
0.4

Study Details

Study Description

Brief Summary

The purpose of this feasibility study is to develop and initially test a dialogue-based psychosocial intervention aimed at promoting coping and psychosocial wellbeing following an acute stroke. The intervention is carried out by primary care registered nurses or other appropriate health professionals. The intervention included persons with and without aphasia.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Psychosocial support and counselling
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Psychosocial Wellbeing Following Stroke: Developing and Testing a Psychosocial Nursing Intervention for Primary Care
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Psychosocial support and counselling

There is only one arm as this is a pilot and feasibility study.

Behavioral: Psychosocial support and counselling

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39) [baseline and 2 weeks after end of intervention]

Secondary Outcome Measures

  1. Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39) [baseline and 12 months after end of intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18 years old or above

  • acute stroke

  • 4-8 weeks poststroke

Exclusion Criteria

  • Other serious disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oslo University hospital Oslo Norway

Sponsors and Collaborators

  • University of Oslo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marit Kirkevold, Professor, University of Oslo
ClinicalTrials.gov Identifier:
NCT01912014
Other Study ID Numbers:
  • 2.2007.37 (REK)
  • 16369 (Social science data)
First Posted:
Jul 30, 2013
Last Update Posted:
Jul 30, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Marit Kirkevold, Professor, University of Oslo

Study Results

No Results Posted as of Jul 30, 2013