Dataset Information

Text Messaging and Home Blood Pressure Monitoring for Patients with Uncontrolled Hypertension: Proposal for a Feasibility Pilot Randomized Controlled Trial.

ABSTRACT:

Background

A decrease in blood pressure, even modestly (ie, 2 mmHg), lowers cardiovascular morbidity and mortality. Low patient adherence to antihypertensive medication is the most significant modifiable patient-related barrier to achieving controlled blood pressure. Preliminary studies have shown that SMS text messaging and home blood pressure monitoring (HBPM) can be effective in promoting medication adherence and blood pressure control. The best strategy to engage with older patients of low socioeconomic status who are low adopters of technology and disproportionally affected by uncontrolled hypertension is still unknown.

Objective

The objective of this study is to improve blood pressure control in the older, low socioeconomic status population. The study will test two aims: First, we aim to evaluate the feasibility of conducting a randomized controlled trial by using an SMS-based approach among nonadherent, older patients of low socioeconomic status who have uncontrolled hypertension. Feasibility will be assessed in terms of recruitment rates per month (primary outcome); patient acceptability will be evaluated by monitoring retention rates and SMS response rates and using the validated Systems Usability Scale (secondary outcomes). Second, we aim to estimate the effects of the SMS approach on lowering blood pressure and adherence to antihypertensive medications.

Methods

We will recruit 24 patients of low socioeconomic status with uncontrolled hypertension (systolic BP>140 mmHg or diastolic BP>90 mmHg) showing low medication adherence and taking at least two antihypertensives, who have presented to two outpatient clinics of Wake Forest Baptist Health (Winston Salem, North Carolina, USA). Participants will be randomly assigned to either SMS and HBPM (n=12) or usual care and HBPM (n=12) intervention. Clinicians adjusting the patients' medications will be blinded to the study assignment. Text messages will be sent from a secure platform to assess medication adherence and HBPM on a weekly basis. The content and delivery frequency of the proposed SMS intervention are based on input from three focus groups conducted in Spring 2019. Participants in both study arms will receive education on HBPM and using an HBPM device. We hypothesize that we will successfully recruit 24 participants and the intervention will be acceptable to the participants. It will also improve medication adherence (assessed by question Medication Adherence Questionnaire scores) and blood pressure control.

Results

Our study was funded in July 2020. As of May 2021, we have enrolled 6 participants.

Conclusions

Our findings will help design a larger efficacy trial to advance the field of eHealth delivery systems particularly for older adults of low socioeconomic status. This study addresses a highly significant topic and targets a population of high morbidity and mortality that has been traditionally underrepresented in clinical trials.

Trial registration

ClinicalTrials.gov NCT03596242; https://clinicaltrials.gov/ct2/show/NCT03596242.

International registered report identifier (irrid)

PRR1-10.2196/18984.

SUBMITTER: Campos CL

PROVIDER: S-EPMC8164117 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundAlthough most patients with SARS-CoV-2 infection can be safely managed at home, the need for hospitalization can arise suddenly.ObjectiveTo determine whether enrollment in an automated remote monitoring service for community-dwelling adults with COVID-19 at home ("COVID Watch") was associated with improved mortality.DesignRetrospective cohort analysis.SettingMid-Atlantic academic health system in the United States.ParticipantsOutpatients who tested positive for SARS-CoV-2 between 23 March and 30 November 2020.InterventionThe COVID Watch service consists of twice-daily, automated text message check-ins with an option to report worsening symptoms at any time. All escalations were managed 24 hours a day, 7 days a week by dedicated telemedicine clinicians.MeasurementsThirty- and 60-day outcomes of patients enrolled in COVID Watch were compared with those of patients who were eligible to enroll but received usual care. The primary outcome was death at 30 days. Secondary outcomes included emergency department (ED) visits and hospitalizations. Treatment effects were estimated with propensity score-weighted risk adjustment models.ResultsA total of 3488 patients enrolled in COVID Watch and 4377 usual care control participants were compared with propensity score weighted models. At 30 days, COVID Watch patients had an odds ratio for death of 0.32 (95% CI, 0.12 to 0.72), with 1.8 fewer deaths per 1000 patients (CI, 0.5 to 3.1) (P = 0.005); at 60 days, the difference was 2.5 fewer deaths per 1000 patients (CI, 0.9 to 4.0) (P = 0.002). Patients in COVID Watch had more telemedicine encounters, ED visits, and hospitalizations and presented to the ED sooner (mean, 1.9 days sooner [CI, 0.9 to 2.9 days]; all P < 0.001).LimitationObservational study with the potential for unobserved confounding.ConclusionEnrollment of outpatients with COVID-19 in an automated remote monitoring service was associated with reduced mortality, potentially explained by more frequent telemedicine encounters and more frequent and earlier presentation to the ED.Primary funding sourcePatient-Centered Outcomes Research Institute.

Project description:Importance:Mobile applications (apps) may help improve hypertension self-management. Objective:To investigate the effect of an artificial intelligence smartphone coaching app to promote home monitoring and hypertension-related behaviors on systolic blood pressure level compared with a blood pressure tracking app. Design, Setting, and Participants:This was a 2-group, open, randomized clinical trial. Participants with uncontrolled hypertension were recruited in 2016 and 2017 and were followed up for 6 months. Data analysis was performed from April 2019 to December 2019. Interventions:Intervention group participants received a smartphone coaching app to promote home monitoring and behavioral changes associated with hypertension self-management plus a home blood pressure monitor. Control participants received a blood pressure tracking app plus a home blood pressure monitor. Main Outcomes and Measures:The primary study outcome was systolic blood pressure at 6 months. Secondary outcomes included self-reported antihypertensive medication adherence, home monitoring and self-management practices, measures of self-efficacy associated with blood pressure, weight, and self-reported health behaviors. Results:There were 333 participants randomized, and 297 completed the follow-up assessment. Among the participants who completed the study, the mean (SD) age was 58.9 (12.8) years, 182 (61.3%) were women, and 103 (34.7%) were black. Baseline mean (SD) systolic blood pressure was 140.6 (12.2) mm Hg among intervention participants and 141.8 (13.4) mm Hg among control participants. After 6 months, the corresponding mean (SD) systolic blood pressures were 132.3 (15.0) mm Hg and 135.0 (13.9) mm Hg, with a between-group adjusted difference of -2.0 mm Hg (95% CI, -4.9 mm Hg to 0.8 mm Hg; P = .16). At 6 months, self-confidence in controlling blood pressure was greater in the intervention group (0.36 point on a 5-point scale; 95% CI, 0.18 point to 0.54 point; P < .001). There were no significant differences between the 2 groups in other secondary outcomes. The adjusted difference in self-reported physical activity was 26.7 minutes per week (95% CI, -5.4 minutes per week to 58.8 minutes per week; P = .10). Subgroup analysis raised the possibility that intervention effects differed by age. Conclusions and Relevance:Among individuals with uncontrolled hypertension, those randomized to a smartphone coaching app plus home monitor had similar systolic blood pressure compared with those who received a blood pressure tracking app plus home monitor. Given the direction of the difference in systolic blood pressure between groups and the possibility for differences in treatment effects across subgroups, future studies are warranted. Trial Registration:ClinicalTrials.gov Identifier: NCT03288142.

Project description:Although skin cancer is largely preventable, it affects nearly 1 of 5 US adults. There is a need for research on how to optimally design persuasive public health indoor tanning prevention messages.The objective of our study was to examine whether framed messages on indoor tanning behavioral intentions delivered through short message service (SMS) text messaging would produce (1) positive responses to the messages, including message receptivity and emotional response; (2) indoor tanning efficacy beliefs, including response efficacy and self-efficacy; and (3) indoor tanning risk beliefs.We conducted a pilot study of indoor tanning prevention messages delivered via mobile phone text messaging in a sample of 21 young adult women who indoor tan. Participants completed baseline measures, were randomly assigned to receive gain-, loss-, or balanced-framed text messages, and completed postexposure outcome measures on indoor tanning cognitions and behaviors. Participants received daily mobile phone indoor tanning prevention text messages for 1 week and completed the same postexposure measures as at baseline.Over the 1-week period there were trends or significant changes after receipt of the text messages, including increased perceived susceptibility (P<.001), response efficacy beliefs (P<.001), and message receptivity (P=.03). Ordinary least squares stepwise linear regression models showed an effect of text message exposure on self-efficacy to quit indoor tanning (t6=-2.475, P<.02). Ordinary least squares linear regression including all measured scales showed a marginal effect of SMS texts on self-efficacy (t20=1.905, P=.08). Participants endorsed highly favorable views toward the text messaging protocol.This study supports this use of mobile text messaging as an indoor tanning prevention strategy. Given the nature of skin cancer risk perceptions, the addition of multimedia messaging service is another area of potential innovation for disseminating indoor tanning prevention messages.

Project description:BackgroundHypertension is a leading cause of cardiovascular and kidney disease in the United States, yet blood pressure (BP) control at a population level is poor and worsening. Systematic home BP monitoring (HBPM) programs can lower BP, but programs supporting HBPM are not routinely used. The MyBP program deploys automated bidirectional text messaging for HBPM and disease self-management support.ObjectiveWe aim to produce a qualitative analysis of input from providers and staff regarding implementation of an innovative HBPM program in primary care practices.MethodsSemistructured interviews (average length 31 minutes) were conducted with physicians (n=11), nurses, and medical assistants (n=6) from primary care settings. The interview assessed multiple constructs in the Consolidated Framework for Implementation Research domains of intervention characteristics, outer setting, inner setting, and characteristics of individuals. Interviews were transcribed verbatim and analyzed using inductive coding to organize meaningful excerpts and identify salient themes, followed by mapping to the updated Consolidated Framework for Implementation Research constructs.ResultsHealth care providers reported that MyBP has good ease of use and was likely to engage patients in managing their high BP. They also felt that it would directly support systematic BP monitoring and habit formation in the convenience of the patient's home. This could increase health literacy and generate concrete feedback to raise the day-to-day salience of BP control. Providers expressed concern that the cost of BP devices remains an encumbrance. Some patients were felt to have overriding social or emotional barriers, or lack the needed technical skills to interact with the program, use good measurement technique, and input readings accurately. With respect to effects on their medical practice, providers felt MyBP would improve the accuracy and frequency of HBPM data, and thereby improve diagnosis and treatment management. The program may positively affect the patient-provider relationship by increasing rapport and bidirectional accountability. Providers appreciated receiving aggregated HBPM data to increase their own efficiency but also expressed concern about timely routing of incoming HBPM reports, lack of true integration with the electronic health record, and the need for a dedicated and trained staff member.ConclusionsIn this qualitative analysis, health care providers perceived strong relative advantages of using MyBP to support patients. The identified barriers suggest the need for corrective implementation strategies to support providers in adopting the program into routine primary care practice, such as integration into the workflow and provider education.Trial registrationClinicalTrials.gov NCT03650166; https://tinyurl.com/bduwn6r4.