Abstract
BACKGROUND
Blood pressure (BP) control was only 43.7% in the National Health and Nutrition Survey (NHANES) survey in 2017–2018. Scalable, nonclinic-based strategies to control BP are needed. We therefore conducted a pilot trial of a text-messaging intervention in a national network of retail outlet health kiosks with BP devices. All study procedures were conducted remotely.
METHODS
Eligible individuals (N = 140), based on average BP greater than or equal to 140/90 mm Hg at kiosks during the prior year, were randomized to intervention vs. usual care. Intervention consisted of tailored text messages providing educational information with embedded links to educational videos on topics related to BP control. BP measurements were obtained at kiosks at 3, 6, and 12 months following randomization; control was defined as BP < 140/90 mm Hg. Follow-up at 12 months was curtailed due to SARS-CoV-2. We therefore combined 12-month (N = 62) or carried forward 6-month (N = 61) data as the primary end point.
RESULTS
Participants were 51.4% male, 70.7% white/Caucasian, had mean age of 52.1 years, and mean baseline BP 145.5/91.8 mm Hg. At the end point, 37.7% intervention vs. 27.4% usual care subjects achieved BP control (difference, 10.3%, 95% confidence interval -6.2%, 26.8%). In an intention-to-treat analysis with multiple imputation of missing data, 12-month BP control was 29.0% vs. 19.8% favoring intervention (difference, 9.2%. 95% confidence interval -7.3%, 25.7%); intervention vs. control differences in adjusted mean BP levels were systolic BP: -5.4 mm Hg (95% confidence interval: -13.5, 2.7) and diastolic BP: +0.6 mm Hg (95% confidence interval: -4.2, 5.4).
CONCLUSIONS
These pilot results support the potential for a highly scalable text-messaging intervention to improve BP.
CLINICAL TRIALS REGISTRATION
Trial Number NCT03515681.
Keywords: clinical trial, hypertension, high blood pressure, m-health
Graphical Abstract
Graphical Abstract.
INTRODUCTION
Cardiovascular disease (CVD) remains the leading cause of death1 and health care cost in the United States.2 Hypertension is the leading remediable risk factor for CVD in the United States and globally,3-6 with prevalence of 32% in US adults.7 Blood pressure (BP) control, defined as <140/90 mm Hg in the National Health and Nutrition Survey (NHANES), improved between 2000 and 2010, flattened at a peak of 53.9% in 2013–2014, and then declined to only 43.7% in 2017–2018.7 Strategies to improve hypertension control in the United States have focused on the physician–patient interaction, system factors in the health care provider system, and extension beyond the traditionally defined health care system. Efforts related to physician–patient interactions focused on overcoming clinical inertia8-10 have had mixed success,11-13 as have pay-for-performance models using BP control benchmarks.14-16 The system approach is exemplified by the Kaiser Permanente of Northern California hypertension control program, which involved a registry, an evidence-based practice guideline, medical assistant visits for BP monitoring and medication adjustment, performance feedback, and promotion of single pill combination therapy. This program achieved a control rate of 80.4% compared with 64.1% in the national comparison group and 69.4% in the California comparison of commercially insured individuals.17 An uncontrolled evaluation of a similar program in the Veterans Administration system also found improved control.18 Others have reported improved BP control using telehealth-based interventions linked to clinical practice.19-21 Extension beyond the traditionally defined health care system is exemplified by the trial conducted by Victor et al. in barbershops in Los Angeles, in which pharmacists in the barbershops prescribed antihypertensive medications to African American men with hypertension with positive results.22 Similar efforts have been made in church settings.23-26 While these strategies have been found to be effective, each has limitations. Interventions directed at the physician–patient interaction and at system factors in clinical settings do not reach individuals who do not go to the doctor. Barber- and church-based community outreach programs have different limitations related to expense, scalability, sustainability, and breadth of reach. Self-monitoring alone has not been effective in lowering BP; with co-interventions, there are positive findings, but these trials have all been in the context of clinical practice.27
Retail outlet health kiosks are widely accessible, provide free BP measurements, and thereby have the potential to address these limitations by providing a platform for automated feedback to individuals outside the clinical setting and without requiring direct contact with the health care system. We therefore developed an M-health intervention for kiosk users and designed a pilot web-based randomized trial to demonstrate feasibility and to assess the preliminary effectiveness of a scalable text-messaging intervention in a nonclinic-based context where over 35,000,000 BP measurements per year occur.
METHODS
Setting
Higi is a private company that installs and supports more than 10,000 health kiosks in retail outlets in 49 states, with a kiosk within 5 miles of the residence of approximately 73% of the US population. Kiosks include a BP device and a seat that rests on a scale. A touch screen permits individuals to register by providing a contact e-mail address, so that sequential BP measurements can be linked and displayed. The BP devices are FDA cleared, standardized, and linked to the registration database, thereby providing a platform for intervention. The FDA clearance for the device is for a midarm circumference range of 25–40 cm, for both systolic and diastolic BP. In the 1-year period 1 January 2018 to 31 December 2018, a total of 36,104,964 BP measurements were obtained at Higi kiosks. Of these, 11,760,375 (33%) were greater than or equal to 140/90 mm Hg.
Participants, sample size, and randomization
Eligibility required individuals to be registered with Higi, so that an e-mail was available for contact and invitation to participate in the trial. Eligibility also required at least 2 BP measurements in the 12-month period 1 January 2018–31 December 2018 (the year prior to the study) with average greater than or equal to 140/90 mm Hg for all measurements in that year and at least one measurement greater than or equal to 140/90 mm Hg within 90 days of enrollment. Individuals with recorded weight > 300 pounds were excluded to avoid cuff size artifact.
Ineligible individuals were removed from the Higi database for the period 1 January 2018–31 December 2018; we then randomly sampled a total of 2,000 eligible individuals. These individuals were sent e-mails with a link to the study website inviting them to participate. Of these, 177 consented and 140 were randomized (Figure 1) to intervention plus usual care or usual care alone, allocated 1:1 within strata defined by age (18–49, 50–85 years), sex, and region of the country (Midwest, Northeast, Southeast, West) in which the kiosk was located, in block sizes of 4. The 33 subjects who were not randomized were excluded due to saturation of randomization strata. Randomization was generated probabilistically in real time at the trial data coordinating center under the direction of the trial statistician (J.L.P.T.). The sample size for the pilot trial was determined to establish feasibility of recruitment, implementation of the intervention and trial website, follow-up, and signal of intervention effect, but not to have power for statistical significance. The first subject was randomized on 6 March 2019 and the last subject on 17 April 19.
Figure 1.
Flow chart of randomization and follow-up.
Consent procedure and baseline questionnaire
Written informed consent was obtained electronically from all participants, and the trial was approved by the Institutional Review Board of Columbia University. The trial was registered at Clinicaltrials.gov (NCT03515681). Consent was obtained on the trial website. A baseline questionnaire was similarly administered remotely on the trial website prior to randomization. The baseline questionnaire included items related to demographics and to specific barriers to care and BP control. Subjects were asked to rank their top 3 barriers to hypertension control from a list of choices. The baseline BP was defined as the most recent kiosk BP value recorded before entry into the trial.
Intervention and usual care
Intervention.
General educational information messages about high BP were sent to all intervention subjects. These messages addressed topics such as the importance of following up for high BP, high BP can lead to health problems unless it is treated, a health care provider should be seen for treatment of high BP, medications lower BP effectively, and taking medications daily is necessary for medication to be effective. There were 10 separate message sequences, one for each of these priority topics. The order of the sets of messages to be sent was tailored based on the responses to the baseline questionnaire item asking which topics were of greatest interest and priority to the individual. In partnership with Mytonomy (Mytonomy.com), a private company that hosts remote access to libraries of brief (2–3 minute), health educational videos, we embedded live links to a library of BP videos in the intervention text messages. These videos addressed topics including: What is hypertension, How do different classes of BP drugs work, The role of diet and exercise, Medication adherence, What target BP should be on average, and Strategies for addressing obstacles to medication adherence, access to care, and goal BP achievement.
In addition, interactive text messages were sent specific to the subject’s most recent kiosk BP level, which was interfaced to the study data coordinating center. If the BP was ≥140/90 mm Hg at a measurement occasion, text messages were sent advising them to see a health care provider to receive care for high BP, that the minimal goal is <140/90 mm Hg for people with hypertension, and to return to a Higi kiosk in 2 weeks to measure the BP again. A reminder to return was sent both one week and 2 days prior to the 2-week due date. For the reminder 2 days before, subjects were asked to respond whether they saw or spoke to a health care provider for their elevated BP. If the subject did not return for repeat BP measurement, a text message was sent weekly with gentle reminders to seek care and to return for re-measurement, in addition to other messages related to specific topics. If the kiosk BP level remained elevated on return to the health kiosk, the text message loop continued, while if the BP was <140/90 mm Hg, positive messages were sent for improving their BP, reminding them to maintain contact with their health care provider for BP management, and asking them to return in one month for a recheck.
Usual care.
Individuals randomized to usual care received health information routinely provided to individuals measuring their BP at a Higi health kiosk. The device provides the BP measurement and a graphical statement that the BP level falls into one of five categories: normal BP: <120/80 mm Hg; elevated BP: 120–129/<80 mm Hg; high BP (hypertension stage 1): 130–139 mm Hg systolic or 80–89 mm Hg diastolic; high BP (hypertension stage 2): greater than or equal to 140 mm Hg systolic or greater than or equal to 90 mm Hg diastolic; hypertensive crisis: greater than or equal to 180 mm Hg systolic and/or greater than or equal to 120 mm Hg diastolic, with advice for those in this category to consult a doctor immediately or seek emergency medical care. The intervention group also received these messages.
Both groups received usual care. Thus, the trial compared intervention plus usual care to usual care. Participants were not blinded to group assignment. All study materials including the consent form, questionnaire, text messages, and videos were available in English and Spanish. Participants indicated language preference for messages and video by text.
Follow-up
Follow-up BP measurements were obtained at kiosks at 3, 6, and 12 months after randomization with a window for completion of plus or minus 30 days. Participants in both groups were sent the same text reminders beginning when the follow-up window opened and until completion of the BP measurement or close of the window.
Statistical analysis
The prespecified primary outcome was the difference between intervention and control in proportion of subjects with controlled BP defined as systolic BP < 140 mm Hg and diastolic BP < 90 mm Hg, at 12 months. The ratio of these proportions (relative risk) was calculated with adjustment for stratification variables. Secondary outcomes included mean systolic (SBP) and diastolic (DBP) levels at 12-month follow-up in the 2 groups, which were compared using t-tests, and the proportions achieving the primary end point at 3 and 6 months. Many kiosks were closed in March 2020, due to SARS-CoV-2, during the 12-month follow-up window. The pilot trial was ended on 30 July 2020, with DSMB approval, when it became apparent that the kiosks would not reopen in the foreseeable future. At that time, 123/140 of the randomized subjects (88%) had completed the 6-month follow-up, of whom 62 also completed the 12-month follow-up. All individuals who completed the 12-month follow-up also completed the 6-month follow-up. We therefore conducted the primary analysis using the 12-month data point for those with 12-month follow-up (N = 62) and the 6-month data point for those who had 6-month follow-up, but not 12-month follow-up (N = 61) (Figure 1). All analyses were completed using SAS ONDEMAND FOR ACADEMICS 3.8 and SAS version 9.4 (for multiple imputation).
The fully conditional specification method of multiple imputation28 was used to address missing follow-up data for N = 7 at 3 months, N = 17 at 6 months, and N = 78 subjects at 12 months. The imputation model included date of enrollment (since those enrolled later were much more likely to have missed the 12-month follow-up), assignment group (intervention + usual care vs. usual care only), stratum, the baseline, 3-month, and 6-month systolic and diastolic BP, and other variables that were independently associated with missingness and/or the 12-month systolic or diastolic BP. Using predictive mean matching, 200 complete data data sets were generated, the above-specified analysis was performed on each, and results from the 200 analyses were aggregated using the MIANALYZE procedure in SAS (version 9.4).
RESULTS
Participants were 51.4% male, 70.7% white or Caucasian, and had a mean age of 52.1 years and mean baseline BP of 145.5/91.8 mm Hg. Baseline characteristics of the intervention and control groups are shown in Table 1. Of the 140 subjects randomized, 131 completed follow-up at month 3, 123 at month 6, and 62 at month 12 (Table 2). There were no adverse events; one subject dropped out.
Table 1.
Demographic and other baseline characteristics of participants in ROKHYT
| Intervention | Control | Total | P-value | ||||
|---|---|---|---|---|---|---|---|
| N | (%) | N | (%) | N | (%) | ||
| Sex | 0.866 | ||||||
| Male | 36 | (51.4) | 37 | (52.9) | 73 | (52.1) | |
| Female | 34 | (48.6) | 33 | (47.1) | 67 | (47.9) | |
| Race | 0.868 | ||||||
| American Indian or Alaska Native | 0 | (0) | 0 | (0) | 0 | (0) | |
| Asian or South Asian | 4 | (5.7) | 3 | (4.3) | 7 | (5.0) | |
| Native Hawaiian or other Pacific Islander | 0 | (0) | 0 | (0) | 0 | (0) | |
| Black or African American | 9 | (12.9) | 8 | (11.4) | 17 | (12.1) | |
| White or Caucasian | 51 | (72.9) | 48 | (68.6) | 99 | (70.7) | |
| More than one race | 2 | (2.8) | 2 | (2.8) | 4 | (2.9) | |
| Other, unknown, or not reported | 4 | (5.7) | 9 | (12.9) | 13 | (9.3) | |
| Ethnicity | 0.746 | ||||||
| Hispanic/Latino/Latina | 8 | (11.4) | 9 | (12.8) | 17 | (12.1) | |
| Non-Hispanic/Latino/Latina | 61 | (87.2) | 58 | (82.9) | 119 | (85.0) | |
| Unknown or not reported | 1 | (1.4) | 3 | (4.3) | 4 | (2.9) | |
| Educational experience | 0.778 | ||||||
| Less than high school | 1 | (1.4) | 0 | (0.0) | 1 | (0.7) | |
| High school diploma or GED | 6 | (8.6) | 5 | (7.1) | 11 | (7.9) | |
| Some college | 21 | (30.0) | 22 | (31.4) | 43 | (30.7) | |
| College graduate | 41 | (58.6) | 40 | (57.1) | 81 | (57.9) | |
| Did not respond | 1 | (1.4) | 3 | (4.3) | 4 | (2.9) | |
| Current health insurance | 0.950 | ||||||
| Yes | 61 | (87.1) | 59 | (84.3) | 120 | (85.7) | |
| No | 8 | (11.4) | 8 | (11.4) | 16 | (11.4) | |
| Did not respond | 1 | (1.4) | 3 | (4.3) | 4 | (2.9) | |
| Regular health care provider | 0.370 | ||||||
| Yes | 57 | (81.4) | 59 | (84.3) | 116 | (82.9) | |
| No | 12 | (17.1) | 8 | (11.4) | 20 | (14.3) | |
| Did not respond | 1 | (1.4) | 3 | (4.3) | 4 | (2.9) | |
| Mean | (SD) | Mean | (SD) | Mean | (SD) | ||
| Age (years) | 52.8 | (12.2) | 51.4 | (11.2) | 52.1 | (11.7) | 0.504 |
| Systolic blood pressure ( mm Hg) | 146.7 | (20.6) | 144.4 | (17.0) | 145.5 | (18.9) | 0.462 |
| Diastolic blood pressure ( mm Hg) | 92.2 | (12.2) | 91.3 | (12.7) | 91.8 | (12.4) | 0.695 |
Table 2.
Number and proportion of participants with blood pressure controlleda at each follow-up
| N randomized | Intervention (N = 70) | Control (N = 70) | Difference (95% CI) |
|---|---|---|---|
| 3 Months | 24/67 (35.8%) | 20/64 (31.3%) | 4.6% (−11.6%, 20.7%) |
| 6 Months | 22/61 (36.1%) | 19/62 (30.6%) | 5.4% (−11.2%, 22.1%) |
| 12 Months | 13/37 (35.1%) | 7/25 (28.0%) | 7.1% (−16.2%, 30.5%) |
| 6 or 12 Months | 23/61 (37.7%) | 17/62 (27.4%) | 10.3% (−6.2%, 26.8%) |
Numerators of fractions are numbers controlled; denominators are numbers completing each follow-up blood pressure measurement. Abbreviation: CI, confidence interval.
aSystolic blood pressure < 140 mm Hg and diastolic blood pressure < 90 mm Hg.
At the combined 6- and 12-month end point, 23 of 61 subjects in the intervention group (37.7%) achieved BP control compared with 17 of 62 (27.4%) in the usual care group (difference in proportions, 10.3%, 95% confidence interval [CI]: −6.2%, 26.8%). The proportions in each group achieving control at each follow-up are shown in Table 2. Mean systolic BP was 5.8 mm Hg lower in the intervention than the control group (95% CI: 0.9, 12.5 mm Hg), while the difference in mean diastolic BP was less than 1 mm Hg (Table 3).
Table 3.
Mean blood pressure at final measurement (6 or 12 months)
| Intervention | Control | Difference (95% CI) | |
|---|---|---|---|
| Mean (SD) | Mean (SD) | ||
| Systolic blood pressure (mm Hg) | 141.2 (17.91) | 147.0 (19.65) | 5.8 (−0.9, 12,5) |
| Diastolic blood pressure (mm Hg) | 88.0 (11.90) | 88.8 (12.73) | 0.8 (−3.6, 5.2) |
Abbreviation: CI, confidence interval.
In the intention-to-treat analysis with multiple imputation of missing data, the overall 12-month BP control rate was 29.0% in the intervention group and 19.8% in the control group; difference = 9.2% (95% CI −7.3%, 25.7%). The Mantel–Haenszel relative risk was 1.49 (95% CI: 0.72, 3.06), P = 0.28. The intervention vs. control differences in adjusted mean BP levels at 12-month follow-up were as follows: SBP: −5.4 mm Hg (95% CI: −13.5, 2.7), P = 0.19 and DBP: +0.6 mm Hg (95% CI: –4.2, 5.4), P = 0.80.
The numbers of participants with SBP < 140 mm Hg and DBP < 90 mm Hg by stratum are presented in Supplementary Table 1.
DISCUSSION
We conducted a pilot randomized trial based in a national network of retail outlet health kiosks in which 140 individuals were randomized to an automated text message intervention plus usual vs. usual care to improve BP control. The proportion achieving the primary end point of BP control, defined as <140/90 mm Hg, was greater in the intervention group vs. usual care by 9.2% in the intention-to-treat analysis with imputation for missing data. SBP was reduced in this analysis by 5.4 mm Hg more in the intervention group. These differences did not reach statistical significance, consistent with expectations for a pilot trial.
Analysis of shortfalls in recent public health initiatives to reduce CVD, specifically the Million Hearts Initiative,29 has highlighted the importance of BP control as having the potential to save more lives on a population basis than any other clinical intervention.29 As noted in this analysis, while lack of access to care remains an issue, nearly 90% of those with uncontrolled hypertension have health insurance.29 Thus, although improved health system performance remains an important goal, nonoffice-based interventions have the potential to reach individuals who may not go to the medical office or who go infrequently.
Context
Approximately 97% of American adults own a cell phone.30 This percentage is similar across gender, race/ethnicity, education level, income, urban/suburban/rural, and age with the exception of those 65 and over, where the rate is 80%. Mobile health (mHealth) has the potential to increase access, improve health literacy, promote adherence and engagement, link to self-monitoring, and thereby to improve health outcomes.31 A recent review of evidence related to mHealth concluded, however, that the evidence base is relatively weak.31 Results have been reported from only a small number of trials of text messaging to improve BP control. One of these studies was conducted in South Africa32 and the second in a small US sample.33 These results support the use of text messaging to improve hypertension control but have limitations. Text messages have also been shown to be effective as reminders encouraging patients to record BP measurements34 and to improve adherence to medication.35-37 A recent review of randomized trials of text messaging in chronic disease management found mixed results.38 The ROKHYT pilot trial adds new data to this limited but emerging evidence base.
Limitations
First, ROKHYT was designed as a pilot study and therefore was underpowered to find statistically significant differences between groups or to provide precise estimates of intervention effects. Second, it was not possible to blind participants to the behavioral intervention. This was addressed in part by using an automated BP measurement method at the health kiosk and the same follow-up intervals in both groups. Analysts were blinded to study group. Third, the BP measurements were obtained at health kiosks in retail outlets rather than under fully standardized research conditions.39 Thus, observed BP levels may not correspond precisely to what might have been observed in a clinic-based trial. However, such differences are likely to be random rather than differential in the intervention vs. the control group and were unavoidable in the context of the pragmatic trial we conducted. Fourth, individuals enrolled in the ROKHYT pilot trial tended to be better educated than the overall US population. Fifth, the kiosk BP device has been cleared by FDA but has not been validated according to an accepted protocol. Sixth, the trial was interrupted by closure of the kiosks due to SARS-CoV-2 during the interval between the 6- and 12-month follow-up, and attrition was lower at 12 months in the intervention vs. control group. We combined data from the 6- and 12-month follow-up time points, whichever was later, and in addition performed an analysis using multiple imputation methods for missing data, with very similar results.
Strengths
The ROKHYT pilot trial was pragmatic in that the eligibility criteria were broad; recruitment was outside the clinical setting; the intervention was highly acceptable, low cost, and scalable; intensity of follow-up was low and targeted specifically to the trial end point; and the trial outcome was directly relevant to participants.40 Second, the trial was entirely conducted remotely, without study or clinical staff present at the point of BP measurement, through a secure web portal and using texting. Third, loss to follow-up was low, taking into account the closure of the health kiosks due to SARS-CoV-2 at the time of the 12-month follow-up. Fourth, ROKHYT is unique is using retail outlet health kiosks as a platform for an intervention to improve BP control. Fifth, the favorable findings for achieving BP control and reduction in SBP, while as expected not reaching statistical significance, were of large enough magnitude to have clinical and public health importance if replicated in a larger trial.
In conclusion, the randomized ROKHYT pilot trial showed the potential for a highly scalable and potentially cost-effective intervention to improve BP control. The pilot trial also showed the feasibility of conducting such a trial remotely. The next step would be to conduct a fully powered randomized trial.
Supplementary Material
FUNDING
The study was supported by National Heart, Lung, and Blood Institute (R34HL137659) to S.S.
DISCLOSURE
Dr. Siddiqui was Founder & Chief Medical Officer at Higi from 2012 to 2019. He is presently a member of Higi’s Clinical Advisory Council and holds equity in Higi. None of the other authors have conflicts.
DATA AVAILABILITY
Interested investigators may access the data through the ROKHYT Data Coordinating Center (J.L.P.T.). Use of the data will be based on appropriate assurance that participant consents are honored.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
Interested investigators may access the data through the ROKHYT Data Coordinating Center (J.L.P.T.). Use of the data will be based on appropriate assurance that participant consents are honored.