Summary

Eligibility
for people ages 21-80 (full criteria)
Dates
study started
estimated completion

Description

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. 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.

Details

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 coming in for 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 assessment for adherence. At the end of this 2 month stage, participants will come in for an 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 (1 reminder per day) or low intensity (1 reminder per week) booster + self-monitoring compared to self-monitoring alone. Adherence will be assessed by phone at 5 months as an interim measurement and an 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 assessment and a final in-person assessment at 12 months.

Keywords

Bipolar Disorder Non-Adherence, Medication Hypertension iTAB-CV Self-Monitoring iTAB-CV + Self Monitoring Self Monitoring iTAB-CV + Self Monitoring - High Intensity Booster iTAB-CV + Self Monitoring - Low Intensity Booster

Eligibility

You can join if…

Open to people ages 21-80

  • Age range: from 21 to 80
  • Have a clinical diagnosis of Bipolar Disorder for at least 2 years duration as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)
  • Have elevated systolic blood pressure ≥130 at screening
  • Have received a diagnosis of hypertension per patient self-report at least 6 months prior to enrollment
  • Have been prescribed at least one regularly scheduled antihypertensive medicine for 3 or more months since diagnosis
  • Be poorly adherent (defined as missing 20% or more of medication within either the past week or past month) with prescribed antihypertensive medication
  • Have their own cellular phone in order to receive text messages as part of the intervention

You CAN'T join if...

  • Unable/unwilling to participate in psychiatric interviews. This will include individuals, 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 for suicide will be excluded from study participation. The suicide risk assessment will be informed by standardized assessments of psychiatric symptoms, the Mini-International Neuropsychiatric Interview (MINI), and the Montgomery Asberg Depression Rating Scale (MADRS). Individuals with active suicidal ideation and recent suicide attempt or current intent and plan will be excluded from study participation. Individuals who score a ≥ 5 on item 10 of the MADRS will be considered to be at high risk for suicide, although individuals with MADRS scores lower than 5 could potentially be excluded if either the psychologist or psychiatrist PIs believe that the individual is at high immediate risk for suicide based upon other input or information. In the event that a potential study participant is determined to be at high risk for suicide, that individual will not be enrolled and the study staff will immediately implement procedures for the safety of the individual. Once that individual is no longer at risk, they may be rescreened for possibility enrollment in the study
  • Individuals who are monolingual, non-English speaking will be excluded. Given the proposed sample sizes of the iTAB-CV + SM and SM alone treatment arms in the proposed study, it would not be practical to conduct sub-group analyses. Based upon our BD adherence work and RCT, which drew upon a population similar to the proposed trial, there were no potential subjects who were excluded from the studies due to inability to speak English. Hispanic individuals made up 3.6% of those enrolled

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Case Western Reserve University
ID
NCT04675593
Study Type
Interventional
Last Updated