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首页> 外文期刊>JMIR Research Protocols >An Internet-Based Counseling Intervention With Email Reminders that Promotes Self-Care in Adults With Chronic Heart Failure: Randomized Controlled Trial Protocol
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An Internet-Based Counseling Intervention With Email Reminders that Promotes Self-Care in Adults With Chronic Heart Failure: Randomized Controlled Trial Protocol

机译：基于Internet的电子邮件提醒心理咨询干预措施，可促进患有慢性心力衰竭的成年人的自我保健：随机对照试验协议

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Background Chronic heart failure (CHF) is a public health priority. Its age-standardized prevalence has increased over the past decade. A major challenge for the management of CHF is to promote long-term adherence to self-care behaviors without overtaxing available health care resources. Counseling by multidisciplinary health care teams helps to improve adherence to self-care behaviors and to reduce the rate of death and hospitalization. In the absence of intervention, adherence to self-care is below recommended standards. Objective This trial aims to establish and evaluate a Canadian e-platform that will provide a core, standardized protocol of behavioral counseling and education to facilitate long-term adherence to self-care among patients with CHF. Methods Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure (CHF-CePPORT) is a multi-site, double blind, randomized controlled trial with a 2 parallel-group (e-Counseling + Usual Care vs e-Info Control + Usual Care) by 3 assessments (baseline, 4-, and 12-month) design. We will identify subjects with New York Heart Association Class II or III systolic heart failure from collaborating CHF clinics and then recruit them (n=278) by phone. Subjects will be randomized in blocks within each site (Toronto, Montreal, and Vancouver). The primary outcome will be improved quality of life, defined as an increased number of subjects with an improvement of ≥5 points on the summary score of the Kansas City Cardiomyopathy Questionnaire. We will also assess the following secondary outcomes: (1) diet habits, depression, anxiety, smoking history, stress level, and readiness for change using self-report questionnaires, (2) physical activity level, current smoking status, and vagal-heart rate modulation by physiological tests, and (3) exercise capacity, prognostic indicators of cardiovascular functioning, and medication adherence through medical chart review. The primary outcome will be analyzed using generalized estimation equations with repeated measures on an intention-to-treat basis. Secondary outcomes will be analyzed using repeated-measures linear mixed models with a random effects intercept. All significant main effects or interactions in the statistical models will be followed up with post hoc contrasts using a Bonferroni correction with a 2-sided statistical significance criterion of P <.05. Results This 3.5-year, proof-of-principle trial will establish the e-infrastructure for a pan-Canadian e-platform for CHF that is comprised of a standardized, evidence-based protocol of e-Counseling. Conclusions CHF-CePPORT is designed to improve long-term adherence to self-care behaviors and quality of life among patients with CHF. It will demonstrate a distinct Canadian initiative to build capacity for preventive eHealth services for patients with CHF. Trial Registration ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01864369","term_id":"NCT01864369"}} NCT01864369 ; http://clinicaltrials.gov/ct2/show/ {"type":"clinical-trial","attrs":{"text":"NCT01864369","term_id":"NCT01864369"}} NCT01864369 (Archived by WebCite at http://www.webcitation.org/6Iiv6so7E).
机译：背景慢性心力衰竭（CHF）是公共卫生的重点。在过去的十年中，其年龄标准化的患病率有所增加。 CHF的管理面临的主要挑战是促进长期遵守自我保健行为，而又不会增加可用的保健资源的负担。多学科医疗保健团队的咨询有助于提高对自我保健行为的依从性，并降低死亡率和住院率。在没有干预的情况下，坚持自我护理低于推荐标准。目的该试验旨在建立和评估加拿大的电子平台，该平台将提供核心的标准化行为咨询和教育方案，以促进CHF患者长期坚持自我保健。方法加拿大电子平台在慢性心力衰竭中促进行为自我管理（CHF-CePPORT）是一项多站点，双盲，随机对照试验，其中有2个平行组（电子咨询+通常护理与电子信息控制） +日常护理），通过3个评估（基线，4个月和12个月）设计。我们将从合作的CHF诊所中识别出纽约心脏协会II级或III级收缩性心力衰竭的受试者，然后通过电话招募他们（n = 278）。在每个站点（多伦多，蒙特利尔和温哥华）内，受试者将被随机分组​​。主要结果将是生活质量的改善，生活质量的提高是指堪萨斯城心肌病调查问卷的总分提高≥5分。我们还将评估以下次要结果：（1）饮食习惯，抑郁，焦虑，吸烟史，压力水平和使用自我报告调查表准备改变的意愿;（2）身体活动水平，当前吸烟状况和迷走性心脏病通过生理测试调节心率，以及（3）运动能力，心血管功能的预后指标和通过病历表审查确定药物依从性。将使用广义估计方程对主要结果进行分析，并在意向性治疗的基础上进行重复测量。次要结果将使用具有随机效应截距的重复测量线性混合模型进行分析。统计模型中所有重要的主要影响或相互作用都将通过Bonferroni校正和2侧统计显着性标准P <.05进行事后对比。结果这项为期3.5年的原则验证试验将为CHF的泛加拿大电子平台建立电子基础设施，该平台由标准化的，基于证据的电子咨询协议组成。结论CHF-CePPORT旨在改善CHF患者的长期坚持自我护理行为和生活质量。它将展示加拿大的一项独特计划，旨在为CHF患者建立预防性eHealth服务的能力。试用注册ClinicalTrials.gov {“ type”：“ clinical-trial”，“ attrs”：{“ text”：“ NCT01864369”，“ term_id”：“ NCT01864369”}} NCT01864369; http://clinicaltrials.gov/ct2/show/ {“ type”：“ clinical-trial”，“ attrs”：{“ text”：“ NCT01864369”，“ term_id”：“ NCT01864369”}} NCT01864369（由WebCite存档在http://www.webcitation.org/6Iiv6so7E）。

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