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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Jun 6, 2024
Open Peer Review Period: Jun 5, 2024 - Jun 19, 2024
Date Accepted: Dec 5, 2024
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Digital Home-Based Self-Monitoring System for People with Heart Failure: Protocol for Development of SmartHeart and Evaluation of Feasibility and Acceptability

Maddison R, Nourse R, Daryabeygikhotbehsara R, TEGEGNE TK, Jansons P, Rawstorn JC, Atherton J, Driscoll A, Oldenburg B, Vasa R, Kostakos V, Dingler T, Abbott G, Scuffham P, Manski-Nankervis JAE, Kwasnicka D, Kensing F, Islam SMS, Maeder A, Zhang Y

Digital Home-Based Self-Monitoring System for People with Heart Failure: Protocol for Development of SmartHeart and Evaluation of Feasibility and Acceptability

JMIR Res Protoc 2025;14:e62964

DOI: 10.2196/62964

PMID: 39874581

PMCID: 11815296

Digital home-based Self-monitoring System for People with Heart Failure: Development of SmartHeart and Protocol to evaluate Feasibility and Acceptability

  • Ralph Maddison; 
  • Rebecca Nourse; 
  • Reza Daryabeygikhotbehsara; 
  • Teketo Kassaw TEGEGNE; 
  • Paul Jansons; 
  • Jonathan Charles Rawstorn; 
  • John Atherton; 
  • Andrea Driscoll; 
  • Brian Oldenburg; 
  • Rajesh Vasa; 
  • Vassilis Kostakos; 
  • Tilman Dingler; 
  • Gavin Abbott; 
  • Paul Scuffham; 
  • Jo-Anne Elizabeth Manski-Nankervis; 
  • Dominika Kwasnicka; 
  • Finn Kensing; 
  • Sheikh Mohammed Shariful Islam; 
  • Anthony Maeder; 
  • Yuxin Zhang

ABSTRACT

Background:

Heart failure is a chronic, progressive condition in which the heart cannot pump enough blood to meet the body’s needs. After first diagnosis, 75% of people are readmitted to hospital within one year and 33% die. High healthcare costs and the associated burden of heart failure have led to the emerging application of new technologies to support people living with heart failure to stay well living in the community.

Objective:

In this paper, we introduce the SmartHeart system, provide an overview of our initial development work, and describe the planned SmartHeart evaluation.

Methods:

We used the Integrate, DEsign, Assess and Share (IDEAS) framework to guide the overall development of SmartHeart. Formative work involved a scoping review, Delphi interviews with end-users (people with heart failure and their carers), and stakeholders (healthcare providers involved in the management of heart failure) to formulate the idea, empathise with users, and to identify system features and requirements. We conducted co-design workshops to design and iterate the SmartHeart system. Alpha and Beta testing were conducted. A single arm, multi-centre pilot trial is planned to determine the feasibility and acceptability of SmartHeart prior to evaluation via a randomised controlled trial design.

Results:

Based on formative work and participatory methods, we developed SmartHeart, a comprehensive telemonitoring and behavioural support program for people living with heart failure. The system comprises internet-connected consumer devices (e.g., mobile phones, smart watches, and motion sensors) with an inbuilt conversational agent, smartphone app, and a clinician portal to provide feedback and alerts to individuals carers, and/or their healthcare providers to support self-care behaviours and warning signs of potential episodes of heart failure decompensation.

Conclusions:

Consistent with the need to integrate consumers in health research, a comprehensive program of research, involving the IDEAS framework was used to guide development of the SmartHeart prototype. A key component of that work was the use of co-design involving people with heart failure and healthcare providers to ensure its relevance and applicability to those using the system and the Australian healthcare environment. The next step is a pilot study, which will provide valuable information on feasibility and preliminary effects to inform a larger evaluation trial. SmartHeart has potential to augment existing health services to support people with heart failure to stay well living in the community.


 Citation

Please cite as:

Maddison R, Nourse R, Daryabeygikhotbehsara R, TEGEGNE TK, Jansons P, Rawstorn JC, Atherton J, Driscoll A, Oldenburg B, Vasa R, Kostakos V, Dingler T, Abbott G, Scuffham P, Manski-Nankervis JAE, Kwasnicka D, Kensing F, Islam SMS, Maeder A, Zhang Y

Digital Home-Based Self-Monitoring System for People with Heart Failure: Protocol for Development of SmartHeart and Evaluation of Feasibility and Acceptability

JMIR Res Protoc 2025;14:e62964

DOI: 10.2196/62964

PMID: 39874581

PMCID: 11815296

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