search
Back to results

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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Stroke self-management program
Usual care
Sponsored by
Queensland University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Disease management, Self efficacy, Quality of life, Community integration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Acute public hospital 1
  • Acute public hospital 2
  • Acute public hospital 3

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stroke self-management program

Usual care

Arm Description

The program is aimed at enhancing community-dwelling stroke survivors' post-stroke recovery.

Usual care provided to stroke survivors discharged to their home.

Outcomes

Primary Outcome Measures

Self-efficacy in performing stroke self-management behaviors
Stroke Self-Efficacy Questionnaire

Secondary Outcome Measures

Stroke self-management behaviors
Stroke Self-management Behaviors Performance Scale
Health-related quality of life
Stroke Specific Quality of Life Scale
Depressive symptoms
Geriatric Depression Scale
Community reintegration
Reintegration to Normal Living Index
Outcome expectation
Stroke Self-management Outcome Expectation Scale

Full Information

First Posted
April 9, 2014
Last Updated
November 7, 2016
Sponsor
Queensland University of Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT02112955
Brief Title
A Self-efficacy Enhancing Stroke Self-management Program for Community-dwelling Stroke Survivors
Acronym
SESSMP
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queensland University of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Disease management, Self efficacy, Quality of life, Community integration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stroke self-management program
Arm Type
Experimental
Arm Description
The program is aimed at enhancing community-dwelling stroke survivors' post-stroke recovery.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care provided to stroke survivors discharged to their home.
Intervention Type
Behavioral
Intervention Name(s)
Stroke self-management program
Intervention Description
A nurse-led community-based self-efficacy enhancing stroke self-management program.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Usual care such as hospital-based or community-based health education or services.
Primary Outcome Measure Information:
Title
Self-efficacy in performing stroke self-management behaviors
Description
Stroke Self-Efficacy Questionnaire
Time Frame
One month after the program
Secondary Outcome Measure Information:
Title
Stroke self-management behaviors
Description
Stroke Self-management Behaviors Performance Scale
Time Frame
One month after the program
Title
Health-related quality of life
Description
Stroke Specific Quality of Life Scale
Time Frame
One month after the program
Title
Depressive symptoms
Description
Geriatric Depression Scale
Time Frame
One month after the program
Title
Community reintegration
Description
Reintegration to Normal Living Index
Time Frame
One month after the program
Title
Outcome expectation
Description
Stroke Self-management Outcome Expectation Scale
Time Frame
One month after the program
Other Pre-specified Outcome Measures:
Title
Usefulness of the program
Description
Extent of overall program participation, and other qualitative comments.
Time Frame
Within one week after the completion of the program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Lo
Organizational Affiliation
Queensland University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acute public hospital 1
City
Kowloon
Country
Hong Kong
Facility Name
Acute public hospital 2
City
New Territories
Country
Hong Kong
Facility Name
Acute public hospital 3
City
New Territories
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34813082
Citation
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
Results Reference
derived
PubMed Identifier
29438073
Citation
Lo SHS, Chang AM, Chau JPC. Stroke Self-Management Support Improves Survivors' Self-Efficacy and Outcome Expectation of Self-Management Behaviors. Stroke. 2018 Mar;49(3):758-760. doi: 10.1161/STROKEAHA.117.019437. Epub 2018 Feb 2.
Results Reference
derived
PubMed Identifier
27528049
Citation
Lo SH, Chang AM, Chau JP. Study protocol: a randomised controlled trial of a nurse-led community-based self-management programme for improving recovery among community-residing stroke survivors. BMC Health Serv Res. 2016 Aug 15;16(a):387. doi: 10.1186/s12913-016-1642-9.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs