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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Apr 5, 2020
Date Accepted: Feb 24, 2021

The final, peer-reviewed published version of this preprint can be found here:

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

Campos C, Jones D, Snively B, Rocco M, Pedley C, Atwater S, Moore J

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

JMIR Res Protoc 2021;10(5):e18984

DOI: 10.2196/18984

PMID: 33988513

PMCID: 8164117

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

SMS system for patients with uncontrolled hypertension: a randomized controlled pilot study

  • Claudia Campos; 
  • Deanna Jones; 
  • Beverly Snively; 
  • Michael Rocco; 
  • Carolyn Pedley; 
  • Sara Atwater; 
  • Justin Moore

ABSTRACT

Background:

Decreasing blood pressure numbers even modestly (2mmHg) lowers cardiovascular morbidity and mortality. Low patient adherence to antihypertensive medication is the most significant modifiable patient-related barrier to achieving controlled blood pressure. The Medication Adherence Questionnaire (MAQ) has been well-validated to identify adherence in hypertension and scores have been shown to correlate well with a range of objective adherence measures. Preliminary studies have shown that short message service (SMS) and home blood pressure monitoring (HBPM) can be effective in promoting medication adherence and bloop pressure control. The best strategy to engage with older low socioeconomic status patients who are low adopters of technology and disproportionately affected by uncontrolled hypertension is still unknown.

Objective:

The objective of this proposal is to improve blood pressure control in the older low socioeconomic status population. The study will test two aims: Aim 1) feasibility of conducting a randomized controlled trial utilizing SMS system in non-adherent old low socioeconomic patients with uncontrolled hypertension. Feasibility will be assessed in terms of recruitment rates per month (primary outcome) and patient acceptability by monitoring their retention rates, SMS response rates and with a validated systems usability survey (secondary outcomes); Aim 2) estimate the effects of the SMS approach on blood pressure lowering and adherence to antihypertensive medications.

Methods:

we will recruit 24 low socioeconomic status low adherent patients with uncontrolled hypertension (SBP>140 or DBP>90) and who are taking at least two antihypertensives who present to two outpatient clinics of Wake Forest Baptist Health in Winston Salem, NC. Using a computerized sequence, participants will be randomly assigned to either SMS and HBPM intervention (n=12) vs usual care (n=12). Clinicians who will be adjusting medications will be blinded to study assignment The SMS messages will inquire about medication adherence and HBPM weekly and originate from a secured platform. The content and delivery frequency of the proposed SMS intervention were based on input from three focus groups conducted in the Spring of 2019. Both arms will receive education on HBPM. The control group will also receive a HBPM device at the end of the study. Our hypotheses are that the study will successfully recruit 24 participants and that the intervention will be acceptable to participants. It will also improve medication adherence (by MAQ scores) and blood pressure control (in mmHg).

Results:

Our study is scheduled to begin recruitment in September 2020 and the anticipated completion date is March 31st 2021.

Conclusions:

Our findings will help design a larger efficacy trial to advance the field of eHealth delivery systems particularly for low socioeconomic status older adults. The study addresses a highly-significant topic and targets a high morbidity/mortality population traditionally underrepresented in clinical trials. Clinical Trial: ClinicalTrials.gov Identifier: NCT03596242


 Citation

Please cite as:

Campos C, Jones D, Snively B, Rocco M, Pedley C, Atwater S, Moore J

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

JMIR Res Protoc 2021;10(5):e18984

DOI: 10.2196/18984

PMID: 33988513

PMCID: 8164117

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