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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112955
• Other study ID #: SESSMP01
• Status: Completed
• Phase: N/A
• First received: April 9, 2014
• Last updated: November 7, 2016
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: Queensland University of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics CommitteeAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Stroke self-management program
A nurse-led community-based self-efficacy enhancing stroke self-management program.
• Usual care
Usual care such as hospital-based or community-based health education or services.

Locations

Country	Name	City	State
Hong Kong	Acute public hospital 1	Kowloon
Hong Kong	Acute public hospital 2	New Territories
Hong Kong	Acute public hospital 3	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Queensland University of Technology

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usefulness of the program	Extent of overall program participation, and other qualitative comments.	Within one week after the completion of the program	No
Primary	Self-efficacy in performing stroke self-management behaviors	Stroke Self-Efficacy Questionnaire	One month after the program	No
Secondary	Stroke self-management behaviors	Stroke Self-management Behaviors Performance Scale	One month after the program	No
Secondary	Health-related quality of life	Stroke Specific Quality of Life Scale	One month after the program	No
Secondary	Depressive symptoms	Geriatric Depression Scale	One month after the program	No
Secondary	Community reintegration	Reintegration to Normal Living Index	One month after the program	No
Secondary	Outcome expectation	Stroke Self-management Outcome Expectation Scale	One month after the program	No