HOMe-based HEart Failure Self-Management Programme Study (The HOM-HEMP Study): A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 213
- Locations
- 1
- Primary Endpoint
- HF self care
Study Overview
Brief Summary
Aim: To develop a nurse-led, home-based self-management psychosocial education programme, entitled HOMe-based HEart Failure Self-Management Programme (HOM-HEMP), and evaluate its effects on improving heart failure self-care, cardiac self-efficacy, health-related quality of life (HRQoL), psychological well-being, perceived social support, and clinical outcomes among patients with heart failure in Singapore.
Background: The number of elderly people is expected to increase in the coming decades, and so too the prevalence of with chronic heart failure (HF) is expected to increase. Since HF is a chronic condition, there is a need to develop programmes that will improve the quality of life of older patients who have to manage this condition for years to come.
Design: A stratified, three-arm randomised controlled trial (RCT) will be adopted.
Methodology:
The HOM-HEMP is designed a six-week home-based psychosocial education programme comprising of a specifically developed HF education and self-management toolkit and three biweekly home visits by the research nurse. In addition, participants in experimental group B will receive a supplementary smartphone app.
A consecutive sample of 213 patients with HF will be recruited from the cardiac ward of a tertiary public hospital in Singapore. They will be randomly assigned to the control group, or experimental group A (HOM-HEMP without App) or the experimental group B (HOM-HEMP with App). A research nurse will be delivering the HOM-HEMP intervention to the participants in the experimental groups, while another research assistant who is blinded to participants' group assignment will be responsible for data collection.
Data will be collected at baseline, at 6 weeks from baseline (i.e. immediate after the intervention), and at 3 and 6 months from the baseline. At the end of the programme, a process evaluation will be conducted to assess the acceptability, strengths and weaknesses of the HOM-HEMP based on the participants' perspectives.
Discussion: It is expected the proposed RCT will make a contribution to knowledge development of the effectiveness of the HOM-HEMP and the active ingredients of the programme.
Detailed Description
Specific Aims
The primary aims of this study are:
- To develop a nurse-led, home-based self-management psychosocial education programme, entitled HOMe-based HEart Failure Self-Management Programme (HOM-HEMP)
- To examine its effectiveness on improving HF self-care, cardiac self-efficacy, anxiety and depression levels, health-related quality of life (HRQoL), perceived social support, and clinical outcomes among patients with HF in Singapore.
Study Hypotheses
Study participants will be randomised into one of the three groups: a Control Group (receiving usual care), an Experimental Group A (receiving HOM-HEMP without a supplementary smartphone App), and an Experimental Group B (receiving HOM-HEMP with a supplementary smartphone App).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinically diagnosed with HF
- •21 years or older, which is the legal age to give consent in Singapore
- •able to comprehend Chinese or English;
- •possess and able to use smart mobile phone (e.g. Samsung Galaxy, iPhone) in their daily lives, and
- •able to be followed up at home after hospital discharge.
Exclusion Criteria
- •have unstable angina, resting tachycardia (>120 beats/minute), or severe arterial hypertension;
- •have a terminal illness other than HF, e.g. end-stage renal failure, cancer, severe pulmonary disease;
- •have psychiatric or cognitive impairment that will affect patient's understanding of the study intervention and/or nature of the study
- •are bed-bound or wheelchair-bound that will affect patient's ability to perform self-care
- •No internet access at home
Arms & Interventions
Intervention group A
a 6-week nurse-led, home-based self-management psychosocial education programme (HOM-HEMP)
Intervention: HOM-HEMP (Behavioral)
Intervention group B
HOM-HEMP with the smartphone app.
Intervention: HOM-HEMP with smartphone app (Behavioral)
control group
Participants will receive the standard care provided by the hospital. It consists of all nursing, medical, and follow-up services as needed.
Intervention: Standard Care (Behavioral)
Outcomes
Primary Outcomes
HF self care
Time Frame: Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline
As measured by the Self-Care Heart Failure Index (SCHFI)
Secondary Outcomes
- Health-related quality of life (HRQoL)(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Cardiac Self-Efficacy(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Anxiety and depression levels(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Perceived social support(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
Investigators
Wang Wenru
Assistant Professor
National University of Singapore