NCT02112955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started May 2014

Typical duration for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

April 9, 2014

Last Update Submit

November 7, 2016

Conditions

Stroke

Keywords

StrokeDisease managementSelf efficacyQuality of lifeCommunity integration

Outcome Measures

Primary Outcomes (1)

  • Self-efficacy in performing stroke self-management behaviors

    Stroke Self-Efficacy Questionnaire

    One month after the program

Secondary Outcomes (5)

  • Stroke self-management behaviors

    One month after the program

  • Health-related quality of life

    One month after the program

  • Depressive symptoms

    One month after the program

  • Community reintegration

    One month after the program

  • Outcome expectation

    One month after the program

Other Outcomes (1)

  • Usefulness of the program

    Within one week after the completion of the program

Study Arms (2)

Stroke self-management program

EXPERIMENTAL

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

Behavioral: Stroke self-management programBehavioral: Usual care

Usual care

ACTIVE COMPARATOR

Usual care provided to stroke survivors discharged to their home.

Behavioral: Usual care

Interventions

Stroke self-management programBEHAVIORAL

A nurse-led community-based self-efficacy enhancing stroke self-management program.

Stroke self-management program
Usual careBEHAVIORAL

Usual care such as hospital-based or community-based health education or services.

Stroke self-management programUsual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Acute public hospital 1

Kowloon, Hong Kong

Location

Acute public hospital 2

New Territories, Hong Kong

Location

Acute public hospital 3

New Territories, Hong Kong

Location

Related Publications (3)

  • 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.

    PMID: 34813082DERIVED

  • 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.

    PMID: 29438073DERIVED

  • 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.

    PMID: 27528049DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Suzanne Lo

    Queensland University of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 14, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2016

Study Completion

May 1, 2016

Last Updated

November 9, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(3)