Behavioural Cardiology Research Unit, University Health Network, Toronto, Ontario, Canada.
BMJ Open. 2013 Aug 21;3(8):e003547. doi: 10.1136/bmjopen-2013-003547.
Web-based lifestyle counselling designed to improve adherence to self-management behaviours for diet, exercise and medication has been shown to reduce blood pressure (BP). However, the long-term clinical outcome of these interventions is not established. Our aim was to establish whether an e-counselling program is independently associated with improved clinical outcomes over a 12-month period, as defined by the following criteria: (1) reduction of systolic BP, diastolic BP, pulse pressure and associated risk factors for cardiovascular events; and (2) adherence to self-management behaviour (diet, exercise, smoke-free living and prescribed medication).
Reducing risk with e-based support for adherence to lifestyle change in hypertension is a two-parallel group, double-blind randomised controlled trial that will utilise a two (Groups: e-counselling vs control) by three (assessment intervals: baseline, 4-month and 12-month outcome) design. BP, lipoprotein cholesterol, physical activity and dietary behaviours and psychological distress will be measured at each assessment. We plan to recruit 528 participants (35-74 years of age) diagnosed with stage 1 or 2 hypertension (systolic BP, 140-180 mm Hg; diastolic BP 90-110 mm Hg) from three major cities (Toronto, London, Vancouver) and one rural area (Grey Bruce region) across Canada between February 2012 and July 2015. Controls will receive general educational e-messages on heart healthy living and the e-counselling group will receive tailored e-messages that are matched to their stage of readiness for change. For both groups, e-messages will be sent proactively on a weekly basis during months 1-4, then bi-weekly during months 5-8 and then monthly during months 9-12.
Ethical approval has been obtained from all recruitment sites. This will be one of the first studies to evaluate the long-term efficacy of preventive e-counselling strategies for cardiovascular disease prevention in patients with hypertension. Findings from this study will be used to guide the ongoing development of e-counselling services.
Clinicaltrial.gov NCT01541540; http://clinicaltrials.gov/ct2/show/NCT01541540.
基于网络的生活方式咨询旨在改善饮食、运动和药物治疗的自我管理行为的依从性，已被证明可降低血压（BP）。 然而，这些干预措施的长期临床结果尚不确定。 我们的目的是确定电子咨询计划是否与 12 个月期间的临床改善结果独立相关，其定义如下：（1）收缩压、舒张压、脉压和心血管事件相关危险因素的降低； （2） 自我管理行为（饮食、运动、无烟生活和规定的药物）的依从性。
通过基于网络的支持来降低高血压患者对生活方式改变的依从性的风险是一项两平行组、双盲随机对照试验，将采用两（组：电子咨询与对照组）三（评估间隔：基线、4 个月和 12 个月的结果）设计。在每次评估时，将测量血压、脂蛋白胆固醇、身体活动和饮食行为以及心理困扰。我们计划在 2012 年 2 月至 2015 年 7 月期间，从加拿大三个主要城市（多伦多、伦敦、温哥华）和一个农村地区（格雷布鲁斯地区）招募 528 名年龄在 35-74 岁之间的诊断为 1 期或 2 期高血压（收缩压 140-180mmHg；舒张压 90-110mmHg）的患者。对照组将收到关于心脏健康生活的一般教育电子信息，而电子咨询组将收到与他们的改变准备阶段相匹配的定制电子信息。对于两组，电子信息将在第 1-4 个月期间每周主动发送，然后在第 5-8 个月期间每两周发送一次，然后在第 9-12 个月期间每月发送一次。
所有招募地点均已获得伦理批准。这将是评估预防电子咨询策略在高血压患者中预防心血管疾病的长期疗效的首批研究之一。本研究的结果将用于指导电子咨询服务的持续发展。
Clinicaltrial.gov NCT01541540; http://clinicaltrials.gov/ct2/show/NCT01541540.
