Clinical trial NCT02112955: A Self-efficacy Enhancing Stroke Self-management Program for Community-dwelling Stroke Survivors
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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Disease management
Self efficacy
Quality of life
Community integration
Lead sponsor: Queensland University of Technology
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Self-efficacy in performing stroke self-management behaviors
timeFrame: One month after the program
Secondary outcomes:
measure: Stroke self-management behaviors
timeFrame: One month after the program
measure: Health-related quality of life
timeFrame: One month after the program
measure: Depressive symptoms
timeFrame: One month after the program
measure: Community reintegration
timeFrame: One month after the program
measure: Outcome expectation
timeFrame: One month after the program
Other outcomes:
measure: Usefulness of the program
timeFrame: Within one week after the completion of the program
Locations:
city: Kowloon
country: Hong Kong
facility: Acute public hospital 1
city: New Territories
country: Hong Kong
facility: Acute public hospital 2
city: New Territories
country: Hong Kong
facility: Acute public hospital 3
Study officials:
affiliation: Queensland University of Technology
name: Suzanne Lo
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.