Background: Cardiac pain has been widely considered to be the primary indicator of coronary artery disease. The presentation of cardiac pain and associated symptoms vary in women, making it challenging to interpret as cardiac, possibly cardiac, or noncardiac. Women prefer to consult with family and friends instead of seeking immediate medical care. Objective: This study aimed to assess the user performance (ie, ease of use, efficiency, and errors) and user satisfaction (System Usability Scale; SUS) of a progressive web application for women with cardiac pain. Methods: Following ethics approval, a purposive sample of women aged >18 years with cardiac pain or associated symptoms lasting >3 months and able to speak and read English was recruited to participate in 2 iterative usability testing cycles. The first cycle assessed the performance of and satisfaction with at heart using a web application, and the second cycle assessed the performance of and satisfaction with at heart across various Android and iOS devices. In total, 2 investigators recorded user comments and documented problems. At the end of the testing session, the participants completed the SUS and 4 semistructured interview questions. Results: In total, 10 eligible women participated in usability testing from March 31, 2020, to April 17, 2020 (cycle 1), and from November 17, 2020, to November 30, 2020 (cycle 2). Women across usability testing cycles had a mean age of 55.6 (SD 7.3) years, and most (9/10, 90%) were well educated. In total, 50% (5/10) were employed full or part time, and 60% (6/10) earned >CAD $70,000 (US $48,881.80) annually. Participants across 2 testing cycles reported the overall usability of the at heart progressive web application as highly acceptable (mean SUS score 81.75, SD 10.41). In total, 90% (9/10) of participants rated the user-friendliness of at heart as good or excellent. All participants (10/10, 100%) thought at heart was easy to use and efficient. Only 2 testing errors were noted as high priority; these were low contrast or small font and clarification that the chatbot was not a real person. User satisfaction was assessed using themes that emerged from the debrief and 4 semistructured interview questions; at heart was engaging, comprehensive, understandable, credible, relevant, affirming, personalized, and innovative. Conclusions: This study provides initial support for the at heart progressive web application for women living with cardiac pain and symptoms. Ongoing evaluations in phases 3 and 4 should aim to examine the feasibility and acceptability of and the extent of engagement with the at heart core feature set: Heart Check, Wellness Check, and the library. In addition to assessing effectiveness in the phase-4 effectiveness-implementation hybrid trial (type I), describing and better understanding the context for implementation (eg, race and ethnicity and geography) will be necessary.
Introduction More women experience cardiac pain related to coronary artery disease and cardiac procedures compared with men. The overall goal of this programme of research is to develop an integrated smartphone and web-based intervention (HEARTPA♀N) to help women recognise and self-manage cardiac pain. Methods and analysis This protocol outlines the mixed methods strategy used for the development of the HEARTPA♀N content/core feature set (phase 2A), usability testing (phase 2B) and evaluation with a pilot randomised controlled trial (RCT) (phase 3). We are using the individual and family self-management theory, mobile device functionality and pervasive information architecture of mHealth interventions, and following a sequential phased approach recommended by the Medical Research Council to develop HEARTPA♀N. The phase 3 pilot RCT will enable us to refine the prototype, inform the methodology and calculate the sample size for a larger multisite RCT (phase 4, future work). Patient partners have been actively involved in setting the HEARTPA♀N research agenda, including defining patient-reported outcome measures for the pilot RCT: pain and health-related quality of life (HRQoL). As such, the guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols (SPIRIT-PRO) are used to report the protocol for the pilot RCT (phase 3). Quantitative data (eg, demographic and clinical information) will be summarised using descriptive statistics (phases 2AB and 3) and a content analysis will be used to identify themes (phase 2AB). A process evaluation will be used to assess the feasibility of the implementation of the intervention and a preliminary efficacy evaluation will be undertaken focusing on the outcomes of pain and HRQoL (phase 3). Ethics and dissemination Ethics approval was obtained from the University of Toronto (36415; 26 November 2018). We will disseminate knowledge of HEARTPA♀N through publication, conference presentation and national public forums (Café Scientifique), and through fact sheets, tweets and webinars. Trial registration number [NCT03800082][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03800082&atom=%2Fbmjopen%2F10%2F3%2Fe033092.atom