A Self-efficacy Enhancing Stroke Self-management Program for Community-dwelling Stroke Survivors (SESSMP)

November 7, 2016 updated by: Suzanne Hoi-Shan Lo, Queensland University of Technology

A Randomized Controlled Trial of the Effectiveness of a Nurse-led Self-efficacy Enhancing Stroke Self-management Program for Community-dwelling Stroke Survivors

The aim of this study is to examine the effectiveness of a nurse-led self-efficacy enhancing stroke self-management program on recovery of community-dwelling stroke survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous systematic reviews showed that theory-based stroke self-management programs had potential benefits in improving stroke survivors' quality of life and self-efficacy. However there is a lack of evidence evaluating the effectiveness of a nurse-led theory-based stroke self-management program among community-dwelling Chinese stroke survivors.

This is a parallel group, single-blinded, randomized controlled trial to be held in a community center. All participants will be assessed at two time-points (baseline before randomization, and one month after program completion). Eligible participants will be randomly allocated to either the control group (receiving usual care) or the intervention group (receiving the self-efficacy enhancing stroke self-management program). Participants in the intervention group will receive an additional assessment on usefulness of the program immediately after program completion.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

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

  • Hong Kong
      • Kowloon, Hong Kong
        • Acute public hospital 1
      • New Territories, Hong Kong
        • Acute public hospital 2
      • New Territories, Hong Kong
        • Acute public hospital 3

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:

  • aged 18 years or above
  • have a clinical diagnosis of stroke
  • currently live at home or will be discharged from hospital to home within one week
  • have a Mini Mental State Examination score >18
  • speak Cantonese
  • capable of giving informed consent
  • can attend sessions of the self-efficacy enhancing stroke self-management program
  • can use a phone

Exclusion Criteria:

  • diagnosed with transient ischemic attack, subdural or epidural hemorrhage
  • have cerebrovascular events due to presence of malignancy or head trauma
  • have limited comprehension and receptive aphasia
  • have been diagnosed with schizophrenia, bipolar disorder, or dementia
  • have received a stroke self-management program in the past 12 months as reported by the participants

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stroke self-management program
The program is aimed at enhancing community-dwelling stroke survivors' post-stroke recovery.
Behavioral: Stroke self-management program
A nurse-led community-based self-efficacy enhancing stroke self-management program.
Behavioral: Usual care
Usual care such as hospital-based or community-based health education or services.
Active Comparator: Usual care
Usual care provided to stroke survivors discharged to their home.
Behavioral: Usual care
Usual care such as hospital-based or community-based health education or services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy in performing stroke self-management behaviors
Time Frame: One month after the program
Stroke Self-Efficacy Questionnaire
One month after the program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke self-management behaviors
Time Frame: One month after the program
Stroke Self-management Behaviors Performance Scale
One month after the program
Health-related quality of life
Time Frame: One month after the program
Stroke Specific Quality of Life Scale
One month after the program
Depressive symptoms
Time Frame: One month after the program
Geriatric Depression Scale
One month after the program
Community reintegration
Time Frame: One month after the program
Reintegration to Normal Living Index
One month after the program
Outcome expectation
Time Frame: One month after the program
Stroke Self-management Outcome Expectation Scale
One month after the program

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usefulness of the program
Time Frame: Within one week after the completion of the program
Extent of overall program participation, and other qualitative comments.
Within one week after the completion of the program

Collaborators and Investigators

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

Sponsor

Queensland University of Technology

Investigators

  • Principal Investigator: Suzanne Lo, Queensland University of Technology

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

May 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Estimate)

November 9, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SESSMP01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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