Psychosocial Wellbeing Following Stroke

Quality of Life Clinical Trial

Official title:

Psychosocial Wellbeing Following Stroke: Developing and Testing a Psychosocial Nursing Intervention for Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912014
• Other study ID #: 2.2007.37 (REK)
• Secondary ID: 16369 (Social sc
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 24, 2013
• Last updated: July 29, 2013
• Start date: January 2007
• Est. completion date: December 2011

Study information

• Verified date: July 2013
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or above

• acute stroke

• 4-8 weeks poststroke

Exclusion Criteria

• Other serious disease

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Coping
• Narrative
• Psychosocial
• Quality of Life

Intervention

Behavioral:
• Psychosocial support and counselling

Locations

Country	Name	City	State
Norway	Oslo University hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Bronken BA, Kirkevold M, Martinsen R, Wyller TB, Kvigne K. Psychosocial well-being in persons with aphasia participating in a nursing intervention after stroke. Nurs Res Pract. 2012;2012:568242. doi: 10.1155/2012/568242. Epub 2012 Jul 22. — View Citation

Bronken BA, Kirkevold M. Between the lines: generating good qualitative data in studies involving persons with aphasia. ANS Adv Nurs Sci. 2013 Apr-Jun;36(2):E14-28. doi: 10.1097/ANS.0b013e318290200a. — View Citation

Kirkevold M, Bronken BA, Martinsen R, Kvigne K. Promoting psychosocial well-being following a stroke: developing a theoretically and empirically sound complex intervention. Int J Nurs Stud. 2012 Apr;49(4):386-97. doi: 10.1016/j.ijnurstu.2011.10.006. Epub 2011 Nov 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39)		baseline and 2 weeks after end of intervention	No
Secondary	Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39)		baseline and 12 months after end of intervention	No