Bidirectional Text Messaging for Measurement and Motivation of Medication Adherence in Hypertension, a Pilot Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The goal of this pilot study is to test different approaches to monitor medication adherence
      in hypertension patients, leveraging the NIH-funded Way to Health platform. Patients with
      poor blood pressure control will be recruited from the University of Pennsylvania Health
      System practices and offered remote monitoring with electronic pill bottles, bidirectional
      text messaging or usual care. Our aim is to analyze and compare the effects of remote
      monitoring with electronic pill bottles versus bidirectional messaging on blood pressure
      reduction after 4 months.
    

Detailed description: 
      The goal of this pilot study is to test different approaches to monitor medication adherence
      in hypertension patients, leveraging the NIH-funded Way to Health platform. Patients with
      poor blood pressure control will be recruited from the University of Pennsylvania Health
      System and offered remote monitoring with electronic pill bottles or bidirectional text
      messaging. Our aim is to analyze and compare the effects of remote monitoring with electronic
      pill bottles versus bidirectional messaging on blood pressure reduction after 4 months.

      Patients will be randomized 2:2:1 to Arm A (electronic pill bottle), Arm B (bidirectional
      messaging), and Arm C (usual care). A total of 150 participants will be enrolled in the
      study, with 60 in each intervention arm and 30 in the control. After 4 months all patients
      will complete an in-person follow-up blood pressure measurement and end of program survey. We
      will monitor all patient's medical records for an additional 8 months after the intervention
      to track blood pressure measurement and number of outpatient visits.

      Accrual: Participants in this study will be patients being treated within the UPHS health
      system. They will be identified via daily electronic medical records review by our study
      staff. The study staff will work with UPHS to create a filter for the electronic medical
      record system that will generate a monthly list of patients who may meet the study criteria.
      A study coordinator will review the list of patients to determine eligibility. If patients
      meet the minimal requirements they will be added to the study screening data base and
      contacted via recruitment letter and up to 3 follow-up phone calls. The intervention of the
      study will be 4 months from date of consent, and an additional 8 months of follow-up,
      passively monitoring visit utilization and blood pressure in the electronic medical record.
      After a patient enrolls a message will be sent to their PCP via EPIC to notify their
      physician that their patient is enrolled in our study. At the conclusion of the intervention,
      participants will complete an in-person blood pressure measurement and post-study survey.
      Information about BP measurements will be recorded in EPIC and message will be sent to the
      PCP with the research BP measurement included.

      Analysis Plan: The primary outcome will be the systolic blood pressure during the 4 month
      visit, controlling for the initial systolic blood pressure. Additional outcomes include,
      percent that are normotensive, recruitment and attrition rates, and patient perceptions about
      intervention from survey. We will also track BP measurements from the EMR that is obtained
      through usual care as well as utilization of PCP visits, MPM messaging, and phone calls. We
      will also compare medication adherence between patients with the electron pill bottles and
      the patients with bidirectional messaging. Assuming 5.3mmHg standard deviation of SBP (given
      variability of BP over time) and a two-sided significance level of 0.017 (to accommodate the
      three pairwise comparisons), our sample size of 60 in each intervention arm and 30 in the
      control arm provides 80% power to detect a difference in SBP reduction of 3.75 mmHg between
      either intervention and usual care, and a difference in SBP reduction of 3.1 mmHg between the
      electronic pill bottle and bidirectional text messaging arms.

      Data Safety: Paper-based records will be kept in a secure location and only be accessible to
      personnel involved in the study. Computer-based files will only be made available to
      personnel involved in the study through the use of access privileges and passwords.

      Prior to access to any study-related information, personnel will be required to sign
      statements agreeing to protect the security and confidentiality of identifiable information.

      Wherever feasible, identifiers will be removed from study-related information. Precautions
      are in place to ensure the data is secure by using passwords and encryption, because the
      research involves web-based surveys.
    

Intervention name(s): Electronic Pill Bottle; Bidirectional Text Messaging
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients receive electronic pill bottle for their blood pressure medication. Study team can monitor pill bottle openings. Patients also receive daily text reminders to take their blood pressure medication.; Patients receive daily text reminders to take their blood pressure medication. Patients are asked to text their adherence daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Automated Hovering; Remote Monitoring; Bidirectional Text Messaging