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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


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
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