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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.
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.
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.
Our study was funded in July 2020. As of May 2021, we have enrolled 6 participants.
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.
ClinicalTrials.gov NCT03596242; https://clinicaltrials.gov/ct2/show/NCT03596242
PRR1-10.2196/18984
The successful implementation of the American College of Cardiology/American Heart Association (ACC/AHA) hypertension guidelines based on the SPRINT (Systolic Blood Pressure Intervention Trial) findings will lead to improvements in the health of the American population and reduce the risks posed by heart disease and stroke [
Preliminary studies have shown that SMS text messaging and HBPM can be effective in promoting medication adherence and BP control [
Twenty-four participants aged 60 years and older will be randomized to either the monitoring intervention or to receive usual care and education; they will be followed-up for 12 weeks. See
Usual care patient flow. DBP: diastolic blood pressure; SBP: systolic blood pressure.
Study algorithm. BP: blood pressure; HBPM: home blood pressure monitoring; MAQ: Medication Adherence Questionnaire.
Participants will be randomized to the two study groups by using a computer-based random number generating algorithm. Baseline demographic characteristics of the participants will then be collected. All participants will receive a previously validated Omron Bp785n 10 Series arm blood BP monitor and printed instructions in English or Spanish (as per the AHA) on how to perform HBPM [
Adherence checkpoint:
“No” response:
Additional prompt: If no, alert to study coordinator to place phone call to determine barrier to filling BP medication.
Additional prompt: If yes, phone call to determine side effect from BP medication.
“Yes” response:
Self-monitoring phase:
If the participants report SBP below 90 mmHg and or above 180 mmHg and/or DBP below 50 mmHg and/or above 120 mmHg on more than one occasion, those numbers will be considered to be outside of the threshold range. These thresholds are made based on the recommendations by AHA/ACC hypertension guidelines, which designate a hypertensive urgency to be 180/120 mmHg or higher and hypotension urgency to be 90/50 mmHg or lower [
Patients who do not show up to the follow-up visit will be contacted via phone to assess adherence barriers. The study coordinator will create a telephone encounter in the patient’s electronic health record to document their discussion and route it to the patient’s primary care provider. Patients who refuse participation in the study will be asked for the reason, and their responses will be recorded to determine any barriers to participation. The study coordinator will attempt to contact patients who miss follow-up visits every week up to three times; if the patient still cannot be contacted after three attempts, the patient will be considered “lost to follow-up.” Participants will receive a stipend to compensate them for their time in participating in the study.
The personnel performing the outcome assessments will be blinded to the participants’ study assignments.
All statistical analyses will be performed using SAS 9.3 To accomplish Aim 1, we will examine the number of participants enrolled into the study at each study clinic by month over the course of recruitment phase, as well as the average and overall number of participants enrolled per month within each clinic. These rates will assist us in determining the feasibility of recruiting a sufficient sample for the larger trial, and it will potentially inform protocol adjustments. We will estimate additional indicators for feasibility throughout the trial, including measures of retention of participants through the 12 weeks and adherence to the protocol within each group, as well as acceptability of the intervention as measured by the questionnaire (
Evaluation and outcomes.
Outcome and evaluation | Method | Baseline | During the 12-week intervention | At week 12 | Expected outcome | ||||||
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Recruitment | Track number of enrolled participants per week | ✓ | ✓ |
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24 patients will be recruited in 4 months. |
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Protocol adherence | SMS response rate/week |
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Weekly |
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Monitoring of adherence to protocol | |||||
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Acceptability | Systems Usability Scale (SUS) questionnaire. Track participant discontinuation and loss to follow-up Track proportion of patients screened but excluded because they did not own a phone with SMS capability Track participant discontinuation and loss to follow-up Informal comments from participants |
✓ | Weekly | ✓ |
Monitoring of acceptability; |
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Systolic BP and diastolic BP change | BP will be measured per clinic protocols and extracted from the patient’s electronic medical record. The average change will be calculated and reported in mmHg. | ✓ |
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✓ | Systolic BP and diastolic BP will improve | |||||
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Medication adherence | 8-item Morisky Medication Adherence Questionnaire (MAQ) | ✓ |
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✓ | MAQ scores will improve |
aBP: blood pressure.
The proposed study presents small risks to participants. They will receive usual medical care. The principal investigator will be responsible for the overall monitoring of the data and safety of the study participants. We will use REDCap, a secure online platform designed for research, to collect all patient data. Participants’ demographics (including their education level), comorbidities, number of medications, number of BP medications prescribed, and BP measures will be extracted from Wake One records when available. The level of education will be confirmed verbally with each participant during consent process. Only one participant identifier will appear in the data collection forms.
Our study began recruitment in September 2020, and the anticipated completion date for the recruitment phase is March 31, 2021. This study is funded by CTSI Pilot funding from Wake Forest Baptist Health. This trial has been registered in ClinicalTrials.gov (Identifier: NCT03596242).
The proposed study will evaluate the feasibility of conducting a randomized controlled trial of a new patient-centric SMS delivery system tailored primarily for older adults of low socioeconomic status demonstrating nonadherence to antihypertensive medication. The SMS system was designed with the input of three focus groups composed of older minority patients with hypertension. The study is distinctive in its ability to recruit and test the implementation in a population particularly affected by medication nonadherence and uncontrolled hypertension. To engage patients in health care is considered a key strategy to improve patients' adherence, clinical outcomes, and satisfaction about the care received [
We intend to publish the findings of this study. If successful, we will plan to conduct a larger efficacy randomized controlled trial. The dissemination of these results will help improve BP control in this patient population. In addition, our long-term goal is to develop an automated patient-centric system that will improve monitoring of BP and medication adherence in other ambulatory clinics, to help improve BP control rates among older adults with uncontrolled hypertension who visit other primary care clinics at Wake Forest Baptist Health.
American College of Cardiology
American Heart Association
blood pressure
Research Electronic Data Capture
diastolic blood pressure
home blood pressure monitoring
Medication Adherence Questionnaire
systolic blood pressure
Systolic Blood Pressure Intervention Trial
None declared.