University of Toronto Lawrence S Bloomberg Faculty of Nursing, Toronto, Ontario, Canada
University of Toronto Lawrence S Bloomberg Faculty of Nursing, Toronto, Ontario, Canada.
BMJ Open. 2020 Mar 9;10(3):e033092. doi: 10.1136/bmjopen-2019-033092.
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.
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 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.
NCT03800082.
与男性相比，更多的女性经历与冠状动脉疾病和心脏手术相关的心脏疼痛。本研究计划的总体目标是开发一种集成的智能手机和基于网络的干预措施（HEARTPA♀N），以帮助女性识别和自我管理心脏疼痛。
本方案概述了用于开发 HEARTPA♀N 内容/核心功能集（第 2A 阶段）、可用性测试（第 2B 阶段）和使用试点随机对照试验（RCT）进行评估（第 3 阶段）的混合方法策略。我们正在使用个体和家庭自我管理理论、移动设备功能和移动健康干预措施的普遍信息架构，并遵循医学研究委员会推荐的顺序分阶段方法来开发 HEARTPA♀N。第 3 阶段的试点 RCT 将使我们能够改进原型，为更大的多地点 RCT（第 4 阶段，未来工作）提供信息并计算样本量。患者合作伙伴一直积极参与设定 HEARTPA♀N 的研究议程，包括为试点 RCT 定义患者报告的结果测量指标：疼痛和健康相关生活质量（HRQoL）。因此，使用纳入患者报告结局的临床试验方案指南（SPIRIT-PRO）来报告试点 RCT 方案（第 3 阶段）。定量数据（例如，人口统计学和临床信息）将使用描述性统计数据进行总结（第 2AB 和 3 阶段），并使用内容分析来识别主题（第 2AB 阶段）。将进行过程评估以评估干预措施实施的可行性，并进行初步疗效评估，重点关注疼痛和 HRQoL 的结果（第 3 阶段）。
多伦多大学已获得伦理批准（36415；2018 年 11 月 26 日）。我们将通过出版物、会议演讲和国家公共论坛（科学咖啡馆），以及通过情况说明书、推文和网络研讨会来传播 HEARTPA♀N 的知识。
NCT03800082。
