Randomized Controlled Trial of E-Counseling for Hypertension

Introduction

The combination of pharmacotherapy with lifestyle counseling is recommended by international heart health organizations as the optimal strategy to reduce risk factors for cardiovascular disease.^1–3 In the context of hypertension, behavioral counseling programs for diet and exercise augment usual medical care with an incremental reduction in systolic blood pressure (SBP) of −4.5 mm Hg (95% confidence interval, −7.9 to −1.0) for periods <12 months and −2.3 mm Hg (95% confidence interval, −3.8 to −0.8) for 12 to 24 months.⁴ However, these results were obtained with programs of moderate-to-high intensity where counseling was provided in person and lasted from 30 minutes to ≥6 hours. This poses a major challenge to the feasibility of extending the reach of lifestyle programs to populations with hypertension—which includes 31% of American adults, 22% of Canadian adults, or 40% of the global adult population, as defined by the criteria of 140/90 mm Hg.^5–7

Systematic reviews⁸ and meta-analytic studies^9–11 have noted that e-based interventions for hypertension decrease blood pressure (BP) in a range that is comparable to conventional lifestyle programs. Nevertheless, heterogeneity in treatment effects is a frequently cited problem.^9–11 This variability is problematic because it impedes efforts to determine whether e-counseling offers a viable option as a complementary intervention. Technical reasons for this heterogeneity include the use of diverse technologies (eg, mobile text messaging, wearable monitoring devices) and the use of platforms that operate with different degrees of automation and user interaction. From a clinical perspective, heterogeneity may arise because of the application of variable theories of behavior change (eg, education, gaming, incentive reinforcement), and perhaps most importantly, the absence of a specified model of counseling that can organize the selection and use of e-based tools in the therapeutic program.

The present study used an automated and interactive protocol where the clinical content and method were standardized, evidence-based, and clinically organized by an explicit model of behavioral counseling. The protocol adapted key features from motivational interviewing¹² and cognitive-behavioral therapy¹³ to provide a collaborative, user-centered experience that was consistent with conventional face-to-face programs. We selected a 12-month endpoint as a clinically meaningful marker of treatment stability.

Methods

Data presented in this study are available from the corresponding author pending approval of the Research Ethics Boards of our host institutions and on reasonable request received from qualified researchers trained in human subject confidentiality protocols.

Participants

This trial was approved by the Research Ethics Boards of participating institutions. It was conducted between February 2012 and March 2016. All participants gave written informed consent. We recruited individuals when they accessed the website of Heart and Stroke Canada, which is widely known to the Canadian public. Before accessing educational materials, they were prompted to confirm if they would like to be contacted for a research project on high BP and whether they resided near our recruitment sites: Toronto, Vancouver, London, Grey Bruce region of Ontario, and Prince Edward Island province. Screening criteria included 35 to 74 years of age and diagnosis of stage 1 or 2 hypertension (SBP/diastolic BP [DBP], 130–159/85–99 mm Hg or 160–180/100–110 mm Hg, respectively). Among participants not prescribed medication, hypertension was confirmed by the family physician and a clinic assessment of SBP/DBP ≥140/90 mm Hg. Participants prescribed antihypertensive medications were required to have a baseline SBP/DBP ≥130/85 mm Hg. These participants were also required to have their prescription unchanged for at least 2 months before enrollment to ensure stability of their BP readings. Individuals with comorbidities were excluded if their condition resulted in a complex or atypical presentation of hypertension: for example, clinically significant sleep apnea, kidney disease, psychiatric illness, including depression, alcohol or drug dependence in the previous year, as well as institutional residence, or inability to comprehend English.

Study Design

The present study was registered with www.ClinicalTrials.gov as e-Counseling Promotes Blood Pressure Reduction and Therapeutic Lifestyle Change in Hypertension (REACH). REACH was a multicenter, 2 parallel group, double-blind, randomized controlled trial with repeated assessments at baseline, 4 months, and 12 months (Figure 1). During the 12-month intervention, our e-program proactively contacted participants by email weekly for months 1 to 4, biweekly for months 5 to 8, and monthly for months 9 to 12. Sessions were automated with interactive e-tools and forms that were provided exclusively by the internet (Figure 1).

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Randomization was blocked within 5 recruitment sites in Canada (noted above). The research design of this trial adhered to Consolidated Standards of Reporting Trials guidelines.¹⁴ The e-counseling and control groups were informed that they would receive e-messages for 12 months that would support a heart healthy lifestyle as an essential component of BP management. All subjects were unaware of whether they were allocated to the experimental intervention. They were asked to consent to allow the research team to monitor their BP, lifestyle, and medications at baseline, 4 months, and 12 months. Participants were told that REACH would complement rather than alter the medical treatment provided by their physician.

Randomization was conducted using an algorithm hosted by a secure website, www.randomize.net. Knowledge of treatment allocation was restricted to a research associate who was not part of the REACH team. Participants were instructed to not discuss details of their e-based treatment during assessments. Research personnel conducting assessments, data review, or statistical analyses were blinded to the treatment allocation of participants.

Study Interventions

Both the control and e-counseling arms of REACH were organized by sessions that included a URL that linked participants to their session content. For controls, each session included content from the resource section of the Blood Pressure Action Plan of the Heart and Stroke Foundation of Canada. This content was representative of the e-based support provided by heart health organizations at the inception of this trial. Each article included information aimed at improving self-help skills for managing BP. Topics included reviewing lifestyle and medications with healthcare professionals, monitoring BP, increasing exercise and dietary intake of fruit and vegetables, adhering to medications, decreasing dietary sodium and alcohol, and becoming smoke free. Controls were permitted to log into the Heart and Stroke Foundation website to access heart healthy recipes, as well as e-tools and self-monitoring forms to track BP and changes in self-care behaviors.

The e-counseling intervention was based on a combined protocol of motivational interviewing¹² and cognitive-behavioral therapy¹³ in keeping with guidelines to promote adherence to self-care behaviors¹⁵ (Table 1). The protocol initially guided participants to assess their stage of readiness to adhere to self-care according to the Transtheoretical Model.¹⁶ Participants selected their behavior change priority from a list that included exercise, diet, smoke-free living, and adherence to antihypertensive medications. In consonance with motivational interviewing,¹² e-counseling sessions were initially designed to resolve ambivalence about behavior change. Motivational components helped to build readiness for change by (1) validating the participant’s initial stage of readiness, (2) guiding them to select an intervention goal that was matched to their readiness stage, (3) reinforcing their active and collaborative role in the REACH intervention, and (4) helping them to resolve ambivalence for change by linking their behavior change goal to a salient personal priority.

For participants with elevated readiness, cognitive-behavioral strategies reinforced their efficacy for initiating and sustaining change by (1) educating them about how to set manageable behavioral goals for self-care adherence, (2) outlining progressive steps in the change plan for self-care, (3) facilitating performance-based feedback with self-monitoring tools for BP and self-care behavior, (4) providing rewarding feedback about progress in initiating or sustaining behavior change, (5) maintaining virtual peer support and positive behavioral modeling via video material, and (6) reviewing guidelines to manage stress to sustain therapeutic change in self-care.

The e-counseling intervention was fully automated, and it did not include supplemental contact with our team, outside of clinic assessments at baseline, 4 months, and 12 months (Figure 1). It promoted and reinforced the above motivational and cognitive-behavioral strategies by means of videos, online handouts, and monitoring forms. Extensive use was made of 14 original videos. The initial session included a 10-minute video trailer that oriented participants to the organization and content of their 12-month program. Members of our team introduced each section of the trailer. They also appeared individually in videos used in each session (up to 10 minutes duration) to teach self-care according to their respective expertise in diet, exercise, medications, and smoke-free living. This helped to build a (virtual) therapeutic relationship between participants and the REACH team.

Three types of videos were developed for the e-counseling sessions: (1) expert-type presentations with self-help guidelines for adhering to self-care behavior; (2) an unscripted discussion among peers that provided positive role modeling and guidance as they spoke about how heart healthy living was connected to their personal priorities and how they managed barriers to change; and (3) dramatic vignettes that reflected and validated participant experiences as fictional characters learned to accept the diagnosis of hypertension and then as they planned and carried out lifestyle changes with the support of a healthcare professional or peer. Each scheduled session included supplementary self-help resources, as noted for controls.

Study End points

Primary end points were SBP, DBP, pulse pressure (PP), non–high-density lipoprotein cholesterol (non–HDL-C), total lipoprotein cholesterol (TC), low-density lipoprotein cholesterol, TC/HDL-C ratio, and the Framingham 10-year absolute risk index for cardiovascular disease (FRI). End points were assessed at 4 and 12 months using a method that was consistent with baseline procedures. Each assessment took place at the participant’s local clinic. SBP, DBP, and PP were measured by a validated protocol for automated office BP measurement with the BpTRU device.² Participants were seated for 5 minutes. The BP cuff of appropriate size was applied to the nondominant arm. The nurse/research assistant activated the BpTRU to ensure an accurate reading before exiting the room. The initial recording was discarded. The BpTRU then completed 5 automated BP recordings at 1-minute intervals, of which the mean BP was the recorded value at each assessment. Blood samples were taken by the hospital/clinic laboratory using conventional procedures to assess the 12-hour fasting lipoprotein cholesterol profile. The above-noted data along with a questionnaire were used to compute the FRI.¹⁷

Statistical Analysis

The principal investigator (R.P.N.) had full access to all the data in this trial study, and he is responsible for the integrity of the data analysis. Group means on background characteristics were examined with ANOVA for continuous variables and with χ² tests for categorical variables. Sample size estimation was based on a meta-analysis by Neubeck et al,¹⁰ who reported that the weighted mean difference between e-based interventions versus control in SBP was −4.69 mm Hg, with a pooled SD of 18.81. A total sample required to replicate this outcome with a 2-parallel group design, type 1 error=5% and power=80%, was 528 participants. We estimated a 23% attrition rate for a low contact e-based trial.¹⁸ This resulted in a total sample estimate of 624 participants.

Primary end points were analyzed using an intention-to-treat approach. We examined baseline values for key dependent variables among participants with versus without complete data across end points to determine whether data for these variables were missing at random. Once this was established, generalized linear models evaluated if change from baseline to 4 months and from baseline to 12 months for primary end points was independently associated with e-counseling versus control. Each generalized linear model assessed the independent therapeutic benefit attributable to e-counseling by including the baseline value of each dependent variable, sex, and medications as predictors. Generalized linear models predicting change for SBP, DBP, and PP adjusted for the sum of antihypertensive medications as the medication covariate. Predictors of change in indices of lipoprotein cholesterol included lipid-lowering agents (0=not prescribed, 1=prescribed) as the medication covariate. Predictors of change in the FRI used both antihypertensive and lipid-lowering medications while excluding participants with established cardiovascular disease. If a main effect was not observed in each generalized linear model for e-counseling versus control, as hypothesized, then we examined the treatment-by-sex interaction as a planned analysis with adjustment for baseline values of our dependent variable and medications. Treatment effects were evaluated for significance, P<0.05, 2-sided. Bonferroni correction was used to determine statistical significance for treatment-by-sex interactions.

Results

Patients and Procedures

We enrolled 264 participants who were invited to attend a clinic assessment to confirm their eligibility for REACH (Figure 2).

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Background features for the 2 randomized groups in REACH are presented in Table 2. Mean BP was clinically elevated at baseline. Lipoprotein cholesterol (non–HDL-C, TC, low-density lipoprotein cholesterol, and TC/HDL-C ratio) was within the normal range. The 10-year FRI was in the moderate range.

During the 12-month interval, 83% of participants were taking at least 1 antihypertensive medication, and only 22% of participants were taking a lipid-lowering agent (Table 3). Change in medication prescriptions across assessment intervals was minimal, and treatment groups did not differ in the prevalence of antihypertensive or lipid-lowering medications at baseline (P=0.47 and P=0.57, respectively), 4 months (P=0.77 and P=0.84, respectively), or 12 months (P=0.89 and P=0.70, respectively).

Primary End points

Participants in both control and e-counseling groups significantly decreased SBP and DBP from baseline at 4 and 12 months (Table 4). The magnitude of SBP reduction did not differ between groups at 4 months, but there was significantly greater reduction for e-counseling at 12 months. The magnitude of change in DBP did not differ significantly between e-counseling versus control at either 4 or 12 months (Table 4).

PP reduction from baseline was significant for e-counseling and control at 4 and 12 months. However, PP decreased to a greater degree for e-counseling at both of these end points (Table 4).

At 4 and 12 months, lipoprotein cholesterol (non–HDL-C, TC, low-density lipoprotein cholesterol, and TC/HDL-C ratio) did not deviate significantly from the nonelevated values at baseline for e-counseling and control. Nevertheless, significantly lower non–HDL-C and a trend toward significantly lower TC at 4 months was observed for e-counseling versus control. No other significant group differences in lipoprotein cholesterol were observed at 4 or 12 months (Table 4).

Among participants without established cardiovascular disease (e-counseling, n=128; control, n=122), the FRI decreased significantly from baseline at both 4 and 12 months for e-counseling but not for control. The magnitude of FRI reduction was significantly greater for e-counseling versus control at both 4 and 12 months (Table 4). Supplemental examination of 12-month FRI change confirmed that overall 10-year risk reduction was associated with a decrease in modifiable risk factors: total lipoprotein cholesterol, SBP, and smoking status (Table I in the Data Supplement).

Treatment-by-Sex Interaction Effect

Table II in the Data Supplement presents data for exploratory treatment-by-sex interactions for all primary end points Table 5 presents the influence of sex on treatment for end points where a significant main effect for treatment was absent.

At 12 months, DBP decreased significantly from baseline among women in both e-counseling and control. Among men, DBP decreased significantly only for e-counseling, resulting in lower DBP for e-counseling versus control (Table 5).

At 4 months, low-density lipoprotein cholesterol was significantly lower among men in e-counseling versus control, but there was no group difference among women. At 12 months, men in e-counseling versus control demonstrated significantly lower non–HDL-C and TC, and a statistical trend toward lower TC/HDL-C ratio. No significant group differences were observed among women (Table 5).

Discussion

To our knowledge, REACH is the first double-blind, randomized controlled trial of e-counseling for individuals with hypertension. Therapeutic benefits of e-counseling were observed at 12 months, which suggests stability in the improved outcomes for SBP, PP, and the FRI. A similar 12-month benefit for men in e-counseling was evident for DBP, non–HDL-C, TC, and TC/HDL-C ratio; however, it is important to recall that lipoprotein cholesterol at baseline was not elevated for our sample. The e-counseling protocol in REACH was standardized and evidence based, and key features have been described to increase the opportunity to replicate or improve on its design in keeping with recommendations from previous reviews.^9,11,20 The clinical content of the protocol was based on cognitive-behavioral and motivational models of behavioral counseling.^12,13 In terms of the clinical method, the protocol was clinically organized to guide participants through a 12-month program in a user-centered manner, in keeping with the patient-centered approach recommended for lifestyle counseling in clinic settings.^3,21

Findings of REACH may be timely at this point in the development of e-based interventions for individuals with many chronic medical conditions. Internet access is nearing saturation in developed countries, with a prevalence of household access at 84% while the worldwide estimate for internet household access is 52%.²² Individual internet protocol traffic is projected to increase from 2015 to 2020 at a compounded annual growth rate of 22%,²³ which suggests that it will be increasingly feasible to provide lifestyle interventions that are scalable to individuals throughout both developed and developing nations. But over and above the issue of the technical ability to deliver scalable e-based interventions, there is an acute need to disseminate e-counseling programs with demonstrated efficacy to promote self-care for heart health. Health information seeking is the third most popular online activity, and it is practiced by 72% of internet users.²⁴ However, survey data indicates that 91% of health information seekers with a chronic health condition express the need for guidance to locate and navigate websites that can support their effort to improve self-care knowledge or skill.²⁵ This suggests that there is a fundamental need in e-health to develop protocols that are clinically organized to guide patients for a long-term interval in sustaining self-care behavior. This objective was intrinsic to the clinical methodology used in REACH.

Scientific statements and practice guidelines in North America and Europe recommend the use of a patient-centered counseling model that can educate, support, and collaboratively guide patients in lifestyle change.^3,21 These guidelines draw from evidence-based models of counseling, chiefly motivational interviewing¹² and cognitive-behavioral therapy.¹³ The current findings add further support for these clinical practice models that have historically achieved therapeutic outcomes by (1) actively engaging participants in a collaborative intervention, (2) building motivation and commitment for change, and (3) strengthening efficacy by guiding the patient to develop a repertoire of skills necessary to sustain lifestyle change over the long term. A notable feature of REACH is that it achieved a therapeutic effect similar to conventional programs of lifestyle counseling with minimal demands on the time of study personnel to administer this automated virtual intervention. Furthermore, the technology used in REACH was modest by current standards. This suggests that the evidence-based principles of behavioral counseling used in REACH may be a necessary foundation for e-counseling programs. It is foreseeable that clinical research on promoting self-care behavior will, in the near future, be obliged to evaluate whether these principles are indeed necessary as progress continues toward the goal of using intelligent platforms that can modify e-counseling protocols through machine learning.²⁶

In view of the positive findings of REACH, it is important to consider the generalizability of the present findings. Participants in REACH were recruited as they sought self-help information on heart health from a public website. Our sample was indeed similar to adults who seek health information via the internet in terms of their mean age, educational background, and interest in obtaining support and guidance for self-help.^24,25 Although we successfully enrolled individuals across a wide age range (35–74 years), the mean age of the REACH sample is lower than the population segment of ≥65 years where the prevalence of hypertension is greatest.⁶ The age range for REACH was set with the awareness that hypertension is associated with an increased prevalence of comorbidities when it is expressed among young adults²⁷ and among the elderly.²⁸ Our aim was to recruit subjects who were less likely to have a complicated presentation of hypertension and who were thereby better able to respond to an automated, internet-based behavioral intervention. In working toward scalable interventions of e-counseling, it will be necessary to ensure that automated e-counseling programs that focus on adherence to self-care are well-integrated with conventional medical care to optimize program efficacy for the considerable population of hypertensive individuals with complex medical needs.

Finally, a best evidence guideline based on systematic review with meta-analysis of 123 BP-lowering trials, with 613,815 participants, indicates that every 10 mm Hg decrease in SBP is associated with a reduction of 20% in the risk for cardiovascular events, 17% for coronary heart disease, 27% for stroke, 28% for heart failure, and 13% for all-cause mortality.²⁹ It is noteworthy that e-counseling in the REACH trial facilitated a meaningful decrease of 10 mm Hg in SBP, and it appeared to optimize the efficacy of usual medical care with pharmacotherapy. This finding supports the clinical utility of our e-counseling protocol as a complementary treatment for hypertension. It also indicates that a scalable e-counseling intervention is warranted within the context of a phase III trial, providing that there is fidelity with core features of behavioral counseling that comprised the clinical method and content used in the REACH protocol.

Study Limitations

A limitation of REACH includes the risk of sampling bias. The findings in REACH are generalizable to adults who actively seek health information. This activity is common to ≈3 of 4 internet users.²⁴ Nevertheless, our participants were primarily white with a postsecondary level of education. It is important to determine whether our findings can be replicated with a sample that is more diverse in background characteristics. Funding limitations led to the necessity of stopping recruitment when we had enrolled only 264 (42%) of the target sample of 624 participants. The target sample estimate was based on a meta-analysis of diverse telehealth interventions for hypertension.¹⁰ It is likely that REACH detected significant group differences in our SBP end points with less statistical power as a result of decreased variability in SBP change because of uniform procedures in our intervention and measurement of BP, as well as greater homogeneity in the characteristics of our sample.

The attrition rate of ≈25% is of concern although it may represent a normative response when the intervention is not delivered through the participant’s medical clinic, and contact is limited to 3 assessments for 12 months. There is a need to evaluate whether a multifunctional e-counseling platform can proactively support participants who may require greater assistance to remain engaged with their e-based program.²⁰ In regard to the ability to detect changes in primary outcomes, it bears noting that participants were screened for elevated BP but not for an elevation in lipoprotein cholesterol. It is likely that the REACH trial failed to detect a 12-month treatment effect for lipoprotein cholesterol indices because participants did not present with an elevation at baseline (hence, a floor effect). Resolution of this issue requires a follow-up study where the REACH protocol can be provided to participants with dyslipidemia.

Conclusions

Historically, clinical trials of e-counseling for hypertension have yielded heterogenous treatment effects. This has hampered the ability to determine if an e-based intervention offers a viable complementary strategy for lowering BP and reducing cardiovascular risk. REACH was designed to address this issue by adopting an automated protocol of e-counseling for hypertension that was standardized, evidence-based, and clinically organized by an explicit model of behavioral counseling. REACH demonstrated that e-counseling added independent, long-term therapeutic benefit for reducing BP and cardiovascular risk. This trial demonstrates that e-counseling for hypertension can provide added therapeutic benefit to medical treatment when available technology is combined with a best evidence guideline for behavioral counseling. These findings support the development of a population-based e-counseling strategy that can be evaluated by a phase III clinical trial.

Acknowledgments

We are grateful to George Tomlinson, PhD, Heather Krause, MSc, and Ella Huszti, PhD, for their assistance with statistical analyses and to Ahmad Zbib, MD, CPHIMS-CA, for facilitating recruitment for REACH.

Footnotes