Digital Home-Based Self-Monitoring System for People with Heart Failure: Protocol for Development of SmartHeart and Evaluation of Feasibility and Acceptability
BackgroundHeart failure (HF) is a chronic, progressive condition where the heart cannot pump enough blood to meet the body’s needs. In addition to the daily challenges that HF poses, acute exacerbations can lead to costly hospitalizations and increased mortality. High health...
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JMIR Publications
2025-01-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e62964 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Ralph Maddison |
| collection | DOAJ |
| description |
BackgroundHeart failure (HF) is a chronic, progressive condition where the heart cannot pump enough blood to meet the body’s needs. In addition to the daily challenges that HF poses, acute exacerbations can lead to costly hospitalizations and increased mortality. High health care costs and the burden of HF have led to the emerging application of new technologies to support people living with HF to stay well while living in the community. However, many digital solutions have not involved consumers and health care professionals in their design, leading to poor adoption. The SmartHeart project aimed to codevelop a smart health ecosystem to support the early detection of HF deterioration and encourage self-care, potentially preventing hospitalizations.
ObjectiveThis study aims to provide an overview of the SmartHeart project by describing our approach to designing the SmartHeart system, outlining its features, and describing the planned pilot study to determine the feasibility of the system.
MethodsWe used the Integrate, Design, Assess, and Share (IDEAS) framework to guide the development of the SmartHeart system, involving users (people with HF and their caregivers) and stakeholders (health care providers involved in the management of HF) in its design. SmartHeart is a complete remote heart health monitoring and automated feedback delivery system. It includes 2 user interfaces for patients: an Amazon Alexa conversational agent and a smartphone app. The system collects physiological, symptom, and behavioral data through wireless sensors and self-reports from users. These data are processed and analyzed to provide personalized health insights, self-care support, and alerts in case of health deterioration. The system also includes a web-based user interface for health care professionals, allowing them to access data, send messages to users, and receive notifications about potential health deterioration. A single-arm, multicenter pilot trial (N=20) is planned to determine the feasibility and acceptability of SmartHeart before evaluation through a randomized controlled trial. The primary outcome will be a description of the study's feasibility (recruitment, attrition, engagement, and changes in self-care).
ResultsThe SmartHeart study started in January 2021 on procurement of funding. Recruitment for the pilot trial started in August 2024 and will be completed by March 2025. We have currently enrolled 12 participants. Follow-up of all participants will be completed by the end of May 2025.
ConclusionsWe have co-designed and developed a complete remote heart health monitoring and automated feedback delivery system for the early detection of HF deterioration and prevention of HF-related hospitalizations. 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 the potential to augment existing health services and help people with HF stay well while living in the community.
International Registered Report Identifier (IRRID)DERR1-10.2196/62964 |
| format | Article |
| id | doaj-art-67826bec36ca491a88339cdd910ce6e3 |
| institution | Kabale University |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj-art-67826bec36ca491a88339cdd910ce6e32025-01-28T19:31:29ZengJMIR PublicationsJMIR Research Protocols1929-07482025-01-0114e6296410.2196/62964Digital Home-Based Self-Monitoring System for People with Heart Failure: Protocol for Development of SmartHeart and Evaluation of Feasibility and AcceptabilityRalph Maddisonhttps://orcid.org/0000-0001-8564-5518Rebecca Noursehttps://orcid.org/0000-0002-6410-7064Reza Daryabeygikhotbehsarahttps://orcid.org/0000-0003-4064-978XTeketo Kassaw Tegegnehttps://orcid.org/0000-0002-9137-3632Paul Jansonshttps://orcid.org/0000-0002-8766-0516Jonathan Charles Rawstornhttps://orcid.org/0000-0002-9755-7993John Athertonhttps://orcid.org/0000-0003-2271-578XAndrea Driscollhttps://orcid.org/0000-0002-6837-0249Brian Oldenburghttps://orcid.org/0000-0002-7712-5413Rajesh Vasahttps://orcid.org/0000-0003-4805-1467Vassilis Kostakoshttps://orcid.org/0000-0003-2804-6038Tilman Dinglerhttps://orcid.org/0000-0001-6180-7033Gavin Abbotthttps://orcid.org/0000-0003-4014-0705Paul Scuffhamhttps://orcid.org/0000-0001-5931-642XJo-Anne Elizabeth Manski-Nankervishttps://orcid.org/0000-0003-2153-3482Dominika Kwasnickahttps://orcid.org/0000-0002-5961-837XFinn Kensinghttps://orcid.org/0000-0002-1392-5999Sheikh Mohammed Shariful Islamhttps://orcid.org/0000-0001-7926-9368Anthony Maederhttps://orcid.org/0000-0002-7398-2581Yuxin Zhanghttps://orcid.org/0000-0002-7636-4084 BackgroundHeart failure (HF) is a chronic, progressive condition where the heart cannot pump enough blood to meet the body’s needs. In addition to the daily challenges that HF poses, acute exacerbations can lead to costly hospitalizations and increased mortality. High health care costs and the burden of HF have led to the emerging application of new technologies to support people living with HF to stay well while living in the community. However, many digital solutions have not involved consumers and health care professionals in their design, leading to poor adoption. The SmartHeart project aimed to codevelop a smart health ecosystem to support the early detection of HF deterioration and encourage self-care, potentially preventing hospitalizations. ObjectiveThis study aims to provide an overview of the SmartHeart project by describing our approach to designing the SmartHeart system, outlining its features, and describing the planned pilot study to determine the feasibility of the system. MethodsWe used the Integrate, Design, Assess, and Share (IDEAS) framework to guide the development of the SmartHeart system, involving users (people with HF and their caregivers) and stakeholders (health care providers involved in the management of HF) in its design. SmartHeart is a complete remote heart health monitoring and automated feedback delivery system. It includes 2 user interfaces for patients: an Amazon Alexa conversational agent and a smartphone app. The system collects physiological, symptom, and behavioral data through wireless sensors and self-reports from users. These data are processed and analyzed to provide personalized health insights, self-care support, and alerts in case of health deterioration. The system also includes a web-based user interface for health care professionals, allowing them to access data, send messages to users, and receive notifications about potential health deterioration. A single-arm, multicenter pilot trial (N=20) is planned to determine the feasibility and acceptability of SmartHeart before evaluation through a randomized controlled trial. The primary outcome will be a description of the study's feasibility (recruitment, attrition, engagement, and changes in self-care). ResultsThe SmartHeart study started in January 2021 on procurement of funding. Recruitment for the pilot trial started in August 2024 and will be completed by March 2025. We have currently enrolled 12 participants. Follow-up of all participants will be completed by the end of May 2025. ConclusionsWe have co-designed and developed a complete remote heart health monitoring and automated feedback delivery system for the early detection of HF deterioration and prevention of HF-related hospitalizations. 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 the potential to augment existing health services and help people with HF stay well while living in the community. International Registered Report Identifier (IRRID)DERR1-10.2196/62964https://www.researchprotocols.org/2025/1/e62964 |
| spellingShingle | 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 Digital Home-Based Self-Monitoring System for People with Heart Failure: Protocol for Development of SmartHeart and Evaluation of Feasibility and Acceptability JMIR Research Protocols |
| title | Digital Home-Based Self-Monitoring System for People with Heart Failure: Protocol for Development of SmartHeart and Evaluation of Feasibility and Acceptability |
| title_full | Digital Home-Based Self-Monitoring System for People with Heart Failure: Protocol for Development of SmartHeart and Evaluation of Feasibility and Acceptability |
| title_fullStr | Digital Home-Based Self-Monitoring System for People with Heart Failure: Protocol for Development of SmartHeart and Evaluation of Feasibility and Acceptability |
| title_full_unstemmed | Digital Home-Based Self-Monitoring System for People with Heart Failure: Protocol for Development of SmartHeart and Evaluation of Feasibility and Acceptability |
| title_short | Digital Home-Based Self-Monitoring System for People with Heart Failure: Protocol for Development of SmartHeart and Evaluation of Feasibility and Acceptability |
| title_sort | digital home based self monitoring system for people with heart failure protocol for development of smartheart and evaluation of feasibility and acceptability |
| url | https://www.researchprotocols.org/2025/1/e62964 |
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