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

NCT03108235 | Completed DMC

• 1 other identifier: HSRGWS16Jul007
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

HF self-care; Multicomponent intervention; mHealth; Psychosocial education intervention

Outcome Measures

Primary Outcomes (1)

• HF self care

  As measured by the Self-Care Heart Failure Index (SCHFI)

  Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline

Secondary Outcomes (4)

• 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

• 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

• 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

Other Outcomes (3)

• NYHA Functional Classification

  Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline

• Unplanned Health Service Use

  Data will be collected at 6 weeks, 3 months and 6 months from baseline after the study intervention

• Semi-structured Interview-Process Evaluation

  6 months from baseline after participants complete the study

Study Arms (3)

Intervention group A

EXPERIMENTAL

a 6-week nurse-led, home-based self-management psychosocial education programme (HOM-HEMP)

Behavioral: HOM-HEMP

Intervention group B

EXPERIMENTAL

HOM-HEMP with the smartphone app.

Behavioral: HOM-HEMP with smartphone app

control group

ACTIVE COMPARATOR

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

Behavioral: Standard Care

Interventions

HOM-HEMP BEHAVIORAL

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.

Intervention group A

HOM-HEMP with smartphone app BEHAVIORAL

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.

Intervention group B

Standard Care BEHAVIORAL

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

control group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed with HF
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead
• National University Hospital, Singapore: collaborator

Study Sites (1)

National University of Singapore

Singapore, Singapore

Location

Related Publications (1)

• Jiang Y, Koh KWL, Ramachandran HJ, Nguyen HD, Lim S, Tay YK, Shorey S, Wang W. The effectiveness of a nurse-led home-based heart failure self-management programme (the HOM-HEMP) for patients with chronic heart failure: A three-arm stratified randomized controlled trial. Int J Nurs Stud. 2021 Oct;122:104026. doi: 10.1016/j.ijnurstu.2021.104026. Epub 2021 Jun 30.

  PMID: 34271265 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Wenru Wang, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 11, 2017
• Study Start: June 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)