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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Queensland University of Technology
Sponsor:
Information provided by (Responsible Party):
Suzanne Hoi-Shan Lo, Queensland University of Technology
ClinicalTrials.gov Identifier:
NCT02112955
First received: April 9, 2014
Last updated: April 13, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Stroke
Behavioral: Stroke self-management program
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Effectiveness of a Nurse-led Self-efficacy Enhancing Stroke Self-management Program for Community-dwelling Stroke Survivors

Resource links provided by NLM:


Further study details as provided by Queensland University of Technology:

Primary Outcome Measures:
  • Self-efficacy in performing stroke self-management behaviors [ Time Frame: One month after the program ] [ Designated as safety issue: No ]
    Stroke Self-Efficacy Questionnaire


Secondary Outcome Measures:
  • Stroke self-management behaviors [ Time Frame: One month after the program ] [ Designated as safety issue: No ]
    Stroke Self-management Behaviors Performance Scale

  • Health-related quality of life [ Time Frame: One month after the program ] [ Designated as safety issue: No ]
    Stroke Specific Quality of Life Scale

  • Depressive symptoms [ Time Frame: One month after the program ] [ Designated as safety issue: No ]
    Geriatric Depression Scale

  • Community reintegration [ Time Frame: One month after the program ] [ Designated as safety issue: No ]
    Reintegration to Normal Living Index

  • Outcome expectation [ Time Frame: One month after the program ] [ Designated as safety issue: No ]
    Stroke Self-management Outcome Expectation Scale


Other Outcome Measures:
  • Usefulness of the program [ Time Frame: Within one week after the completion of the program ] [ Designated as safety issue: No ]
    Extent of overall program participation, and other qualitative comments.


Estimated Enrollment: 160
Study Start Date: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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

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
  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: NCT02112955

Contacts
Contact: Suzanne Lo hoishanlo@gmail.com

Locations
Hong Kong
Acute public hospital 1 Not yet recruiting
Kowloon, Hong Kong
Contact: Suzanne Lo       hoishanlo@gmail.com   
Acute public hospital 2 Not yet recruiting
New Territories, Hong Kong
Contact: Suzanne Lo       hoishanlo@gmail.com   
Sponsors and Collaborators
Queensland University of Technology
Investigators
Principal Investigator: Suzanne Lo Queensland University of Technology
  More Information

No publications provided

Responsible Party: Suzanne Hoi-Shan Lo, PhD candidate, Queensland University of Technology
ClinicalTrials.gov Identifier: NCT02112955     History of Changes
Other Study ID Numbers: SESSMP01
Study First Received: April 9, 2014
Last Updated: April 13, 2014
Health Authority: Hong Kong: Ethics Committee
Australia: Human Research Ethics Committee

Keywords provided by Queensland University of Technology:
Stroke
Disease management
Self efficacy
Quality of life
Community integration

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 23, 2014