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

Plain English Summary

Lay summary under review 2

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 with two groups

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 below 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-tests

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 years, 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 Nethersole School of Nursing
-
-
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