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Psychosocial Wellbeing Following Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marit Kirkevold, University of Oslo
ClinicalTrials.gov Identifier:
NCT01912014
First received: July 24, 2013
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Psychosocial
Narrative
Coping
Quality of Life
Behavioral: Psychosocial support and counselling
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Psychosocial Wellbeing Following Stroke: Developing and Testing a Psychosocial Nursing Intervention for Primary Care

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39) [ Time Frame: baseline and 2 weeks after end of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39) [ Time Frame: baseline and 12 months after end of intervention ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2007
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychosocial support and counselling
There is only one arm as this is a pilot and feasibility study.
Behavioral: Psychosocial support and counselling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old or above
  • acute stroke
  • 4-8 weeks poststroke

Exclusion Criteria

  • Other serious disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912014

Locations
Norway
Oslo University hospital
Oslo, Norway
Sponsors and Collaborators
University of Oslo