ClinicalTrials.gov
ClinicalTrials.gov Menu

Psychosocial Wellbeing Following Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01912014
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
Marit Kirkevold, University of Oslo

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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 : January 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

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



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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria

  • Other serious disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912014


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

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marit Kirkevold, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01912014     History of Changes
Other Study ID Numbers: 2.2007.37 (REK)
16369 (Social science data)
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

Keywords provided by Marit Kirkevold, University of Oslo:
stroke
psychosocial
intervention
quality of life