NCT04675593

Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Mood Disorders

Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Mood Disorders.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This proposed 2-stage randomized controlled trial (RCT) will evaluate a personalized patient-centered adherence intervention iTAB-CV + Self-Monitoring (iTAB-CV + SM) vs. Self-Monitoring (SM) alone in poorly adherent hypertensive persons with BD or MDD. This practical, technology-facilitated intervention has potential to improve adherence to antihypertensive medication and reduce SBP among high-risk individuals. The intervention is suitable for primary care or mental health settings and has potential for broad scale-up.

Detailed description

The proposed 5-year project uses a 2-stage randomized controlled trial (RCT) design to evaluate a brief, practical adherence intervention (iTAB-CV) delivered via interactive text messaging+ Self-Monitoring (SM) compared to SM alone. 200 individuals with mood disorder and HTN who are nonadherent with HTN medicine will be enrolled from mental health and primary care settings and the community. The underlying premise is that improving adherence to antihypertensives in BD and MDD is likely to be an efficient path to improving health outcomes in a vulnerable population. Findings on the relationship between habit strength, medication attitudes, mood, and adherence in this project will be generalizable to other populations. The entire observation duration will be 11 months. In stage 1, after consenting and passing screen, participants will receive an automated device (eCAP) to track their use of antihypertensive medication. Participants will use the eCAP for 1 month until completing their baseline assessment. At that time, they will be randomized to either Arm 1 (iTAB-CV + self-monitoring) or Arm 2 (self-monitoring alone). Both interventions will be provided for 2 months with an interim phone/video assessment for adherence. At the end of this 2 month stage, participants will be seen for either a virtual or in-person assessment. In stage 2, following the 3-month assessment, those in iTAB-CV will be re-randomized to receive either a high intensity (starts off with 1 reminder per day and tapers down to 1 reminder per week over the course of 2 months) or low intensity (1 reminder per week) booster + self-monitoring compared to self-monitoring alone. Adherence will be assessed by phone/video at 4 months as an interim measurement and a virtual or in-person assessment will occur at 5 months. In stage 3, investigators will follow participants for another 6 months without intervention with 1 interim phone/video assessment and a final virtual or in-person assessment at 11 months.

Conditions

• Bipolar Disorder
• Non-Adherence, Medication
• Hypertension
• Major Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	iTAB-CV	Individualized Texting for Adherence Building - Cardiovascular (iTAB-CV): a personalized patient-centered text message-based adherence intervention
BEHAVIORAL	Self-Monitoring	The Self-Monitoring (control) group will monitor their medication adherence, take their blood pressure weekly with a home blood pressure monitor provided by the study after being trained by the study staff, and rate their mood weekly in response to a text reminder.

Timeline

• Start date: 2021-03-15
• Primary completion: 2026-05-31
• Completion: 2026-06-01
• First posted: 2020-12-19
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States