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Randomized Controlled Trial of E-Counseling for Hypertension: REACH.
Nolan, RP, Feldman, R, Dawes, M, Kaczorowski, J, Lynn, H, Barr, SI, MacPhail, C, Thomas, S, Goodman, J, Eysenbach, G, et al
Circulation. Cardiovascular quality and outcomes. 2018;(7):e004420
Abstract
BACKGROUND The efficacy of internet-based interventions to improve hypertension management is not established. We evaluated the therapeutic benefit of e-counseling by adapting best evidence guidelines for behavioral counseling. METHODS AND RESULTS This multicenter double-blind randomized controlled trial included assessments at baseline, 4 months, and 12 months. Participants were 35 to 74 years of age and diagnosed with hypertension: systolic/diastolic blood pressure (BP) 130 to 180/85 to 110 mm Hg. BP was assessed by automated office measurement. E-Counseling used multimedia and interactive tools to increase motivation and skill for self-care (exercise, diet, medication adherence, and smoking cessation). Control used self-care education. Frequency of contact by our e-platform was equal for both trial arms. Primary end points were change at 4 and 12 months in systolic BP, diastolic BP, pulse pressure, total lipoprotein cholesterol, low-density lipoprotein cholesterol, total lipoprotein cholesterol/high-density lipoprotein cholesterol ratio, non-high-density lipoprotein cholesterol, and Framingham 10-year cardiovascular risk index. Intention-to-treat analysis used generalized linear models adjusted for baseline measures, sex, and medications. Among 264 participants, mean age was 57.6 years (SE, 0.6), 58% were women, with 83% on antihypertensive medications. At 12 months, e-counseling versus control evoked greater reduction in systolic BP (-10.1 mm Hg [95% confidence interval (CI), -12.5, -7.6] versus -6.0 mm Hg [95% CI, -8.5, -3.5]; P=0.02); pulse pressure (-5.2 mm Hg [95% CI, -6.9, -3.5] versus -2.7 mm Hg [95% CI, -4.5, -0.9]; P=0.04), and Framingham risk index (-1.9% [95% CI, -3.3, -0.5] versus -0.02% [95% CI, -1.2, 1.7]; P=0.02), respectively. Among males in e-counseling versus control, 12-month end points included lower diastolic BP (P=0.01), non-high-density lipoprotein cholesterol (P=0.04), total lipoprotein cholesterol (P=0.03), and a trend for total lipoprotein cholesterol/high-density lipoprotein cholesterol ratio (P=0.07). CONCLUSIONS To our knowledge, this is the first double-blind randomized trial of e-counseling for hypertension. Added benefit for medical therapy was achieved by combining available technology with a clinically organized protocol of motivational and cognitive-behavioral counseling. CLINICAL TRIAL REGISTRATION https://www.clinicaltrials.gov; Unique identifier: NCT01541540.
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Effectiveness of User- and Expert-Driven Web-based Hypertension Programs: an RCT.
Liu, S, Brooks, D, Thomas, SG, Eysenbach, G, Nolan, RP
American journal of preventive medicine. 2018;(4):576-583
Abstract
INTRODUCTION The effectiveness of self-guided Internet-based lifestyle counseling (e-counseling) varies, depending on treatment protocol. Two dominant procedures in e-counseling are expert- and user-driven. The influence of these procedures on hypertension management remains unclear. The objective was to assess whether blood pressure improved with expert-driven or user-driven e-counseling over control intervention in patients with hypertension over a 4-month period. STUDY DESIGN This study used a three-parallel group, double-blind randomized controlled design. SETTING/PARTICIPANTS In Toronto, Canada, 128 participants (aged 35-74 years) with hypertension were recruited. Participants were recruited using online and poster advertisements. Data collection took place between June 2012 and June 2014. Data were analyzed from October 2014 to December 2016. INTERVENTION Controls received a weekly e-mail newsletter regarding hypertension management. The expert-driven group was prescribed a weekly exercise and diet plan (e.g., increase 1,000 steps/day this week). The user-driven group received weekly e-mail, which allowed participants to choose their intervention goals (e.g., [1] feel more confident to change my lifestyle, or [2] self-help tips for exercise or a heart healthy diet). MAIN OUTCOME MEASURES Primary outcome was systolic blood pressure measured at baseline and 4-month follow-up. Secondary outcomes included cholesterol, 10-year Framingham cardiovascular risk, daily steps, and dietary habits. RESULTS Expert-driven groups showed a greater systolic blood pressure decrease than controls at follow-up (expert-driven versus control: -7.5 mmHg, 95% CI= -12.5, -2.6, p=0.01). Systolic blood pressure reduction did not significantly differ between user- and expert-driven. Expert-driven compared with controls also showed a significant improvement in pulse pressure, cholesterol, and Framingham risk score. The expert-driven intervention was significantly more effective than both user-driven and control groups in increasing daily steps and fruit intake. CONCLUSIONS It may be advisable to incorporate an expert-driven e-counseling protocol in order to accommodate participants with greater motivation to change their lifestyle behaviors, but more studies are needed. TRIAL REGISTRATION This study is registered at www.clinicaltrials.gov NCT03111836.
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Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster randomised controlled trial using health coaches.
Browning, C, Chapman, A, Yang, H, Liu, S, Zhang, T, Enticott, JC, Thomas, SA
BMJ open. 2016;(3):e009319
Abstract
OBJECTIVE To assess the effectiveness of a coach-led motivational interviewing (MI) intervention in improving glycaemic control, as well as clinical, psychosocial and self-care outcomes of individuals with type 2 diabetes mellitus (T2DM) compared with usual care. DESIGN Pragmatic cluster randomised controlled trial (RCT). SETTING Community Health Stations (CHSs) in Fengtai district, Beijing, China. PARTICIPANTS Of the 41 randomised CHSs (21 intervention and 20 control), 21 intervention CHSs (372 participants) and 18 control CHSs (296 participants) started participation. INTERVENTION Intervention participants received telephone and face-to-face MI health coaching in addition to usual care from their CHS. Control participants received usual care only. Medical fees were waived for both groups. OUTCOME MEASURES Outcomes were assessed at baseline, 6 and 12 months. Primary outcome measure was glycated haemoglobin (HbA1c). Secondary outcomes included a suite of anthropometric, blood pressure (BP), fasting blood, psychosocial and self-care measures. RESULTS At 12 months, no differential treatment effect was found for HbA1c (adjusted difference 0.02, 95% CI -0.40 to 0.44, p=0.929), with both treatment and control groups showing significant improvements. However, two secondary outcomes: psychological distress (adjusted difference -2.38, 95% CI -4.64 to -0.12, p=0.039) and systolic BP (adjusted difference -3.57, 95% CI -6.08 to -1.05, p=0.005) were robust outcomes consistent with significant differential treatment effects, as supported in sensitivity analyses. Interestingly, in addition to HbA1c, both groups displayed significant improvements in triglycerides, LDL cholesterol and HDL cholesterol. CONCLUSIONS In line with the current Chinese primary healthcare reform, this study is the first large-scale cluster RCT to be implemented within real-world CHSs in China, specifically addressing T2DM. Although a differential treatment effect was not observed for HbA1c, numerous outcomes (including HbA1c) improved in both groups, supporting the establishment of regular, free clinical health checks for people with T2DM in China. TRIAL REGISTRATION NUMBER ISRCTN01010526; Pre-results.
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E-counseling as an emerging preventive strategy for hypertension.
Nolan, RP, Liu, S, Payne, AY
Current opinion in cardiology. 2014;(4):319-23
Abstract
PURPOSE OF REVIEW Lifestyle counseling that includes exercise training, diet modification, and medication adherence is critical to hypertension management. This article summarizes the efficacy of lifestyle counseling interventions in face-to-face, telehealth, and e-counseling settings. It also discusses the therapeutic potential of e-counseling as a preventive strategy for hypertension. RECENT FINDINGS The recent proliferation of telehealth and e-counseling programs increases the reach of preventive counseling for patients with cardiovascular disorders. Blood pressure reduction following these interventions is comparable to face-to-face interventions. However, the effectiveness of e-counseling varies depending on the design features of the core protocol. An evidence-based guideline needs to be established that identifies e-counseling components which are independently associated with blood pressure reduction. As the Internet becomes more sophisticated, e-counseling is demonstrating a therapeutic advantage in comparison with other telehealth interventions. SUMMARY Current evidence supports further development of preventive e-counseling programs for hypertension. A pressing challenge for investigators is to specify key evidence-based components of e-counseling that are essential to the core protocol. In order to achieve this goal, it will be necessary to ensure that e-counseling programs are also clinically organized, in order to guide patients through the process of initiating and sustaining therapeutic behavior change.
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Therapeutic benefit of internet-based lifestyle counselling for hypertension.
Nolan, RP, Liu, S, Shoemaker, JK, Hachinski, V, Lynn, H, Mikulis, DJ, Wennberg, RA, Moy Lum-Kwong, M, Zbib, A
The Canadian journal of cardiology. 2012;(3):390-6
Abstract
BACKGROUND Preventive electronic (e)-counselling has been shown to reduce cardiovascular risk factors. However, heterogeneity in outcomes is commonly reported due to differences in e-protocols. We incorporated key features of an established behavioural therapy, motivational interviewing, to help standardize e-counselling in order to reduce blood pressure in patients with hypertension. METHODS Subjects (n = 387, mean age = 56 years, 59% female, 72% taking ≥ 1 antihypertensive drug) were diagnosed with stage 1 or 2 hypertension. Subjects were randomized to a 4-month protocol of e-counselling (beta version of the "Blood Pressure Action Plan", Heart and Stroke Foundation of Canada) vs waitlist control (general e-information on heart-healthy living). Outcomes were systolic, diastolic, and pulse pressures, and total lipoprotein cholesterol after treatment. RESULTS Intention to treat analysis did not find a significant group difference in outcomes due to contamination across the 2 arms of this trial. However, per protocol analysis indicated that subjects receiving ≥ 8 e-counselling messages (a priori therapeutic dose) vs 0 e-counselling messages (control) demonstrated greater reduction in systolic blood pressure (mean, -8.9 mm Hg; 95% confidence interval [CI], -11.5 to -6.4 vs -5.0 mm Hg; 95% CI, -6.7 to -3.3, P = 0.03), pulse pressure (-6.1 mm Hg; 95% CI, -8.1 to -4.1 vs -3.1 mm Hg; 95% CI, -4.3 to -1.8, P = 0.02) and total cholesterol (-0.24 mmol/L; 95% CI, -0.43 to -0.06 vs 0.05 mmol/L; 95% CI, -0.06 to 0.16, P = 0.03), but not diastolic blood pressure. CONCLUSIONS These findings support the merit of evaluating whether e-counselling can improve blood pressure control and reduce cardiovascular risk over the long-term.