Psychosocial Wellbeing Following Stroke

July 29, 2013 updated by: Marit Kirkevold, University of Oslo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria

  • Other serious disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39)
Time Frame: baseline and 2 weeks after end of intervention
baseline and 2 weeks after end of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39)
Time Frame: baseline and 12 months after end of intervention
baseline and 12 months after end of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 24, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

July 30, 2013

Study Record Updates

Last Update Posted (Estimate)

July 30, 2013

Last Update Submitted That Met QC Criteria

July 29, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2.2007.37 (REK)
  • 16369 (Social science data)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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