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

Last updated: April 5, 2025
Sponsor: Case Western Reserve University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mood Disorders

Vascular Diseases

Stress

Treatment

iTAB-CV

Self-Monitoring

Clinical Study ID

NCT04675593
STUDY20200330
1R01HL149409-01A1
  • Ages 21-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age range: from 21 to 80

  • Have a clinical diagnosis of either Bipolar Disorder or Major Depressive Disorder asdetermined by a standardized diagnostic interview, the Mini-InternationalNeuropsychiatric Interview (MINI)

  • Have elevated systolic blood pressure ≥130 at screening at least 2 different timesduring the screening period

  • Have received a diagnosis of hypertension per patient self-report at least 6 monthsprior to enrollment

  • Have been prescribed at least one regularly scheduled antihypertensive medicine for 3 or more months since diagnosis

  • Have difficulty with adherence to prescribed antihypertensive medication currentlyor in the past based on one of the following questions: Do you ever miss doses ofyour prescribed medications for high blood pressure? Or b. Do you ever try to manageyour high blood pressure on your own without medication?

  • For those with MDD, currently being prescribed an antidepressant medication

  • Have their own cellular phone in order to receive text messages as part of theintervention

Exclusion

Exclusion Criteria:

  • Unable/unwilling to participate in psychiatric interviews. This will includeindividuals, who may be too psychotic to participate in interviews/rating scales

  • Unable/unwilling to give written, informed consent to study participation

  • In the interest of patient safety, individuals who are at high immediate risk forsuicide will be excluded from study participation. The suicide risk assessment willbe informed by standardized assessments of psychiatric symptoms, theMini-International Neuropsychiatric Interview (MINI), and the Montgomery AsbergDepression Rating Scale (MADRS). Individuals with active suicidal ideation andrecent suicide attempt or current intent and plan will be excluded from studyparticipation. Individuals who score a ≥ 5 on item 10 of the MADRS will beconsidered to be at high risk for suicide, although individuals with MADRS scoreslower than 5 could potentially be excluded if either the psychologist orpsychiatrist PIs believe that the individual is at high immediate risk for suicidebased upon other input or information. In the event that a potential studyparticipant is determined to be at high risk for suicide, that individual will notbe enrolled and the study staff will immediately implement procedures for the safetyof the individual. Once that individual is no longer at risk, they may be rescreenedfor possibility enrollment in the study

  • Individuals who are monolingual, non-English speaking will be excluded. Given theproposed sample sizes of the iTAB-CV + SM and SM alone treatment arms in theproposed study, it would not be practical to conduct sub-group analyses. Based uponour BD adherence work and RCT, which drew upon a population similar to the proposedtrial, there were no potential subjects who were excluded from the studies due toinability to speak English. Hispanic individuals made up 3.6% of those enrolled

  • Upper arm circumference > 50cm

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: iTAB-CV
Phase:
Study Start date:
March 15, 2021
Estimated Completion Date:
June 01, 2026

Study 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.

Connect with a study center

  • Case Western Reserve University

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

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