Human-Centered Design of a Digital Health Tool to Promote Effective Self-care in Patients With Heart Failure: Mixed Methods Study

Abstract

Background Effective self-care is an important factor in the successful management of patients with heart failure (HF). Despite the importance of self-care, most patients with HF are not adequately taught the wide range of skills required to become proficient in self-care. Digital health technology (DHT) may provide a novel solution to support patients at home in effective self-care, with the view to enhancing the quality of life and ultimately improving patient outcomes. However, many of the solutions developed to date have failed to consider users’ perspectives at the point of design, resulting in poor effectiveness. Leveraging a human-centered design (HCD) approach to the development of DHTs may lead to the successful promotion of self-care behaviors in patients with HF. Objective This study aimed to outline the HCD, development, and evaluation process of a DHT designed to promote effective self-care in patients with HF. Methods A design thinking approach within the HCD framework was undertaken, as described in the International Organization for Standardization 9241-210:2019 regulations, using a 5-step process: empathize, ideate, design, develop, and test. Patients with HF were involved throughout the design and evaluation of the system. The designed system was grounded in behavior change theory using the Theoretical Domains Framework and included behavior change techniques. Mixed methods were used to evaluate the DHT during the testing phase. Results Steps 1 to 3 of the process resulted in a set of evidence- and user-informed design requirements that were carried forward into the iterative development of a version 1 system. A cross-platform (iOS and Android) mobile app integrated with Fitbit activity trackers and smart scales was developed. A 2-week user testing phase highlighted the ease of use of the system, with patients demonstrating excellent adherence. Qualitative analysis of semistructured interviews identified the early potential for the system to positively influence self-care. Specifically, users perceived that the system increased their confidence and motivation to engage in key self-care behaviors, provided them with skills and knowledge that made them more aware of the importance of self-care behaviors, and might facilitate timely help seeking. Conclusions The use of an HCD methodology in this research has resulted in the development of a DHT that may engage patients with HF and potentially affect their self-care behaviors. This comprehensive work lays the groundwork for further development and evaluation of this solution before its implementation in health care systems. A detailed description of the HCD process used in this research will help guide the development and evaluation of future DHTs across a range of disease use cases.

Use of Human-Centered Design Methodology to Develop a Digital Toolkit to Optimize Heart Failure Guideline-Directed Medical Therapy

“…Authors of 2 previous studies have also used a HCD approach to inform the development of a digital toolkit for HF self-care 19,20 . This research builds upon previous work by engaging clinicians and caregivers, in addition to patients, 19,20 in defining challenges to GDMT optimization and brainstorming solutions for integration into the digital toolkit. By including diverse stakeholders, we will be more likely to develop a solution that meets various end-user needs.…”

“…[15][16][17][18] Two recent studies engaged patients with HF in HCD to develop digital health tools for HF self-care. 19,20 However, there is further opportunity to engage additional stakeholders, such as clinicians and caregivers, in the HCD process as HF self-care and GDMT optimization require a team-based approach.…”

The Virtual Inclusive Digital Health Intervention Design to Promote Health Equity (iDesign) Framework for Atrial Fibrillation: Co-design and Development Study

“…To date, HCD concepts have been applied in the design of DHIs for management of diseases including diabetes, heart failure, and metabolic syndrome [ 10 , 38 , 39 ]. A company specializing in HCD was asked to design an app for Ascensia Diabetes Care Holdings AG with the goal of educating and monitoring patients with diabetes; however, a detailed description of the methods is not available [ 34 ].…”

“…While clinicians were engaged in the design process, patient-level input, which is critical to meeting the needs of end users, was missing. Zachari et al [ 39 ] designed a diabetes self-management app using participatory design, in which understanding patient challenges through empathy was at the center of the design process; however, clinician involvement was missing, as was the case for the design of a heart failure digital tool [ 10 ]. Ahmed et al [ 11 ] described an investigation targeting the need for development of an integrated care platform for individuals with neurodegenerative disease, incorporating feedback from patients, clinicians, and other stakeholders with a mixed methods approach; however, the ideation component of HCD was not reported in that study.…”

“…HCD methodology has been widely adopted in engineering and social sciences. More recently, HCD has been adopted for health care intervention development (eg, web-based health app co-design for refugee and migrant women, diabetes management app development, heart failure digital tool development, and personalized integrated care platform development for people with neurodegenerative disorders) [8][9][10][11][12]. To date, more than 100 design methodologies have been described that use different approaches to HCD, including participatory design and affinity diagramming, among other methodologies [9].…”