Background: Growing evidence supports the benefits of eHealth interventions to increase patient engagement and improve outcomes for a range of conditions. However, ineffective program delivery and usage attrition limit exposure to these interventions and may reduce their effectiveness. Objective: This study aims to evaluate the delivery fidelity of an eHealth intervention, describe use patterns, compare outcomes between low and high users, and identify mediating factors on intervention delivery and receipt. Methods: This is a mixed methods study of an internet-based intervention being evaluated for effectiveness in a randomized controlled trial (RCT). The intervention comprised medication and cardiovascular disease (CVD) risk data uploaded from the primary care electronic health record (EHR); interactive, personalized CVD risk score estimation; goal setting and self-monitoring; an interactive social forum; and optional receipt of heart health messages. Fidelity was assessed over 12 months. Trial outcomes were compared between low and high users. Data sources included program delivery records, web log data, trial data, and thematic analysis of communication records. Results: Most participants in the intervention group (451/486, 93%) had an initial training session conducted by telephone (413/447, 92.4% of participants trained), with a mean duration of 44 minutes (range 10-90 minutes). Staff conducted 98.45% (1776/1804) of the expected follow-ups, mostly by telephone or email. Of the 451 participants who commenced log-ins, 46.8% (211) were categorized as low users (defined as at least one log-in in 3 or fewer months of follow-up), 40.4% (182) were categorized as high users (at least one log-in in more than 3 months of follow-up), and 12.8% (58) were nonadopters (no log-ins after their training session). The mean log-in frequency was 3-4 per month in ongoing users. There was no significant difference between the groups in the primary trial outcome of adherence to guideline-recommended medications (P=.44). In unadjusted analyses, high users had significantly greater eHealth literacy scores (P=.003) and were more likely to meet recommended weekly targets for fruit (P=.03) and fish (P=.004) servings; however, the adjusted findings were not significant. Interactive screen use was highest for goal tracking and lowest for the chat forum. Screens with EHR-derived data held only an early interest for most users. Fidelity measures (reach, content, dose delivered, and dose received) were influenced by the facilitation strategies used by staff, invisible qualities of staff-participant communication, and participants’ responsiveness to intervention attributes. Conclusions: A multifeature internet-based intervention was delivered with high fidelity to the RCT protocol and was regularly used by 40.4% (182/451) of users over 12 months. Higher log-in frequency as an indicator of greater intervention exposure was not associated with statistically significant improvements in eHealth literacy scores, lifestyle changes, or clinical outcomes. Attributes of the intervention and individualized support influenced initial and ongoing use. Trial Registration:

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中文翻译：

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基于互联网的心血管疾病管理干预与初级保健电子健康记录相结合：实施保真度和用户参与度的混合方法评估

背景：越来越多的证据支持电子医疗干预的好处，以增加患者参与度并改善一系列条件的结果。然而，无效的计划交付和使用损耗限制了对这些干预措施的接触，并可能降低其有效性。目标：本研究旨在评估电子医疗干预的交付保真度，描述使用模式，比较低用户和高用户之间的结果，并确定干预交付和接收的中介因素。方法：这是一项基于互联网的干预的混合方法研究，正在随机对照试验 (RCT) 中评估其有效性。干预包括从初级保健电子健康记录 (EHR) 上传的药物和心血管疾病 (CVD) 风险数据；交互式、个性化的 CVD 风险评分评估；目标设定和自我监控；一个互动的社交论坛；和可选的心脏健康信息接收。保真度在 12 个月内进行了评估。在低用户和高用户之间比较了试验结果。数据来源包括程序交付记录、网络日志数据、试验数据和通信记录的专题分析。结果：干预组的大多数参与者 (451/486, 93%) 接受了通过电话进行的初始培训课程 (413/447, 92.4% 的参与者接受了培训)，平均持续时间为 44 分钟（范围 10-90 分钟） . 工作人员进行了 98.45% (1776/1804) 的预期跟进，主要是通过电话或电子邮件。在开始登录的 451 名参与者中，46.8% (211) 被归类为低用户（定义为在 3 个月或更短的随访期内至少登录一次），40。4% (182) 被归类为高用户（在超过 3 个月的随访中至少登录一次），12.8% (58) 是非采用者（培训课程后未登录）。持续用户的平均登录频率为每月 3-4 次。在遵守指南推荐药物的主要试验结果方面，两组之间没有显着差异（P=0.44）。在未经调整的分析中，高用户的电子健康素养得分显着更高 (P=.003)，并且更有可能达到水果 (P=.03) 和鱼类 (P=.004) 建议的每周目标；然而，调整后的结果并不显着。目标跟踪的交互式屏幕使用率最高，而聊天论坛的使用率最低。带有 EHR 衍生数据的屏幕仅对大多数用户产生了早期兴趣。保真度测量（范围、内容、剂量传递、和接受的剂量）受到工作人员使用的促进策略、工作人员与参与者沟通的无形质量以及参与者对干预属性的响应的影响。结论：一项基于互联网的多功能干预对 RCT 协议具有高保真度，并且在 12 个月内被 40.4% (182/451) 的用户定期使用。较高的登录频率作为更大干预暴露的指标与电子健康素养分数、生活方式改变或临床结果的统计学显着改善无关。干预和个性化支持的属性影响了初始和持续使用。试用注册：和参与者对干预属性的反应。结论：一项基于互联网的多功能干预对 RCT 协议具有高保真度，并且在 12 个月内被 40.4% (182/451) 的用户定期使用。较高的登录频率作为更大干预暴露的指标与电子健康素养分数、生活方式改变或临床结果的统计学显着改善无关。干预和个性化支持的属性影响了初始和持续使用。试用注册：和参与者对干预属性的反应。结论：一项基于互联网的多功能干预对 RCT 协议具有高保真度，并且在 12 个月内被 40.4% (182/451) 的用户定期使用。较高的登录频率作为更大干预暴露的指标与电子健康素养分数、生活方式改变或临床结果的统计学显着改善无关。干预和个性化支持的属性影响了初始和持续使用。试用注册：较高的登录频率作为更大干预暴露的指标与电子健康素养分数、生活方式改变或临床结果的统计学显着改善无关。干预和个性化支持的属性影响了初始和持续使用。试用注册：较高的登录频率作为更大干预暴露的指标与电子健康素养分数、生活方式改变或临床结果的统计学显着改善无关。干预和个性化支持的属性影响了初始和持续使用。试用注册：

这只是摘要。阅读 JMIR 网站上的完整文章。JMIR 是互联网时代电子健康和医疗保健领域领先的开放获取期刊。