Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Bipolar Disorder
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bipolar Disorder
- Hypertension
- Non-Adherence, Medication
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 80 years
- Gender
- Both males and females
Description
The proposed 5-year project uses a 2-stage randomized controlled trial (RCT) design (Figure 2) to evaluate a brief, practical adherence intervention (iTAB-CV) delivered via interactive text messaging+ Self-Monitoring (SM) compared to SM alone. 200 individuals with BD and HTN who are < 80% adherent w...
The proposed 5-year project uses a 2-stage randomized controlled trial (RCT) design (Figure 2) to evaluate a brief, practical adherence intervention (iTAB-CV) delivered via interactive text messaging+ Self-Monitoring (SM) compared to SM alone. 200 individuals with BD and HTN who are < 80% adherent 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 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 12 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 2 months 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 4-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 5 months as an interim measurement and a virtual or in-person assessment will occur at 6 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 12 months.
Tracking Information
- NCT #
- NCT04675593
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- University of California, San Diego
- Investigators
- Principal Investigator: Jennifer Levin, PhD Case Western Reserve University