Condition category
Circulatory System
Date applied
02/05/2012
Date assigned
06/06/2012
Last edited
23/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A stroke is a serious condition that occurs when the blood supply to part of the brain is cut off. People who survive a stroke are often left with long-term problems caused by injury to their brain, and some need a long period of rehabilitation before they can recover their former independence. The aim of this study is to assess the effects of a Health Empowerment Intervention for Stroke Self-management (HEISS) on the self-management behaviour and health outcomes of stroke rehabilitation patients.

Who can participate?
Stroke patients aged over 18 who are experiencing functional difficulties

What does the study involve?
Participants are randomly allocated to either the control group receiving usual care or the treatment group receiving HEISS. Usual care is the current stroke rehabilitation programme. HEISS, in addition to the usual care, is designed to empower patients with the knowledge and skills to practice self-management in the stroke rehabilitation journey. The emphasis is on patients’ perspective, taking into account their available resources, needs and preference, to set behavioural goals and an action plan for the highest possible self-care independence. The control group and the treatment group are compared in terms self-efficacy, engagement in self-management behaviours, ability to do daily activities, quality of life, unplanned hospital re-admissions and stroke recurrence. Data is collected at the start of the study and after 1 week, 3 months and 6 months.

What are the possible benefit and risks of participating?
Participants should benefit from HEISS by acquiring essential knowledge and skills, building self-efficacy in self-care performance after stroke, and establishing a supportive relationship with their significant others in the stroke recovery process. The study’s findings should provide directions for bridging hospital and community care for stroke rehabilitation patients. There should be no direct risk or harm from participating in the study except participants may experience tiredness or reduced concentration from prolonged small group interactions. Therefore, the study runs at a short duration (around 20 minutes per session per week) with a short break scheduled according to participants’ needs.

Where is the study run from?
The Chinese University of Hong Kong

When is the study starting and how long is it expected to run for?
May 2012 to May 2014

Who is funding the study?
Health Service Research Fund of the Food and Health Bureau, Hong Kong Government

Who is the main contact?
Dr Janet W.H. Sit

Trial website

Contact information

Type

Scientific

Primary contact

Dr Janet Sit

ORCID ID

Contact details

The Nethersole School of Nursing
Faculty of Medicine
The Chinese University of Hong Kong
-
-
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09100551

Study information

Scientific title

The effect of a Health Empowerment Intervention for Stroke Self-management (HEISS) on the self-management behaviour and health outcomes of stroke rehabilitation patients

Acronym

HEISS

Study hypothesis

Compared with the control group, participants in HEISS will have a significant improvement in:
1. Self-efficacy
2. Self-management behaviour
3. Functional ability in activities of daily living

Null hypothesis:
There will be no difference between control group and treatment group in the above three outcomes.

Ethics approval

Ethics Committee of Hong Kong East Cluster, Hospital Authority, ref: HKEC-2011-038

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Stroke post-acute stage

Intervention

Participants will be randomised to either the control group receiving usual care or the treatment group receiving HEISS

HEISS is based on the Theory of Health Empowerment. It consists of:
Part I: Six weekly small group sessions (20 mins per session and 4-6 participants per group). On completion of the 6 sessions, an individualized mutually agreed action plan and Stroke Self-management Work Book will be made for individual home-based implementation.
Part II: Home-based implementation of the action plan with two nurse reinforcement telephone follow-ups.
Part III: A small group re-union session after the individual home-based implementation (20 mins with the same group composition as in Part I). The purpose is to facilitate personal reflection and experience sharing.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Self-efficacy
2. Engagement in self-management behaviour
3. Functional ability in activities of daily living (ADLs)
Measured pre-test, 1-week, 3-month and 6-month post-test

Secondary outcome measures

1. Quality of life
2. Unplanned hospital re-admission rate
3. Stroke recurrent rate

Overall trial start date

10/05/2012

Overall trial end date

09/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who experience stroke (haemorrhagic or ischaemic) as diagnosed by medical doctors, currently admitted to the ambulatory stroke rehabilitation programme with no pre-morbid disability
2. Experiencing post-stroke functional difficulties that limit participation in self-care activities
3. Aged over 18, with Chinese ethnicity and Cantonese dialect communicability

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

210

Participant exclusion criteria

1. Patients with aphasia and/or cognitive decline [mini–mental state examination (MMSE)<18] that are severe enough to affect participation in the intervention
2. Patients who are currently diagnosed to have depression

Recruitment start date

10/05/2012

Recruitment end date

09/05/2014

Locations

Countries of recruitment

Hong Kong

Trial participating centre

The Chinese University of Hong Kong
-
-
Hong Kong

Sponsor information

Organisation

Hong Kong SAR Government (Hong Kong)

Sponsor details

Health and Health Service Research Fund
Food and Health Bureau
-
-
Hong Kong

Sponsor type

Government

Website

http://www.gov.hk/en/

Funders

Funder type

Government

Funder name

Health Service Research Fund - Hong Kong SAR Government (Hong Kong) ref: 09100551

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/06/2017: Plain English summary added.