HOMe-based HEart Failure Self-Management Programme Study (The HOM-HEMP Study)

NCT03108235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2021-03-15

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

HOM-HEMP

a 6-week nurse-led, home-based self-management psychosocial education programme comprising of a specifically developed HF education and self-management toolkit, three biweekly home visits by the research nurse.

BEHAVIORAL

HOM-HEMP with smartphone app

a 6-week nurse-led, home-based self-management psychosocial education programme comprising of a specifically developed HF education and self-management toolkit, three biweekly home visits by the research nurse. In addition, participants will receive a smartphone app. The smartphone will be used to monitor their health data (such as weight, and blood pressure). The data will be synchronized to a web-connected portal on a remote server. The research nurse would be able to access your data through the web-connected portal and provide consultation through scheduled tele or video conference.

BEHAVIORAL

Standard Care

standard care provided by the hospital. It consists of all nursing, medical, and follow-up services as needed.

Sponsors & Collaborators

Principal Investigators

  • Wenru Wang, PhD · National University of Singapore

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2020-02-28
Completion
2020-02-28

Countries

  • Singapore

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03108235 on ClinicalTrials.gov