Key result
HEARTPA♀N digital health protocol launches to test feasibility and pain self-management in women.
Why the study?
More women experience cardiac pain related to coronary artery disease and cardiac procedures compared with men, necessitating tailored interventions to help them recognise and self-manage cardiac pain.
Does the HEARTPA♀N smartphone and web-based intervention improve pain and health-related quality of life in women with cardiac pain?
Does the HEARTPA♀N smartphone and web-based intervention improve pain and health-related quality of life in women with cardiac pain?
This protocol outlines the development and pilot testing of a digital health intervention to help women self-manage cardiac pain.
May inform sex-specific digital tools for cardiac pain self-management; leaves open efficacy pending prospective evaluation.
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.
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Parry et al. (2020) studied Cardiac pain (n=98). HEARTPA♀N vs. Usual care was evaluated on Feasibility (recruitment, retention, engagement, acceptability) and preliminary efficacy (pain and health-related quality of life). The HEARTPA♀N integrated smartphone and web-based intervention protocol describes a mixed-methods development phase and a planned 98-patient pilot randomized controlled trial to evaluate feasibility and preliminary efficacy for women with cardiac pain.
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