Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT04675593
Brief 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.
Study:
NCT04675593
Study Brief:
Protocol Section:
NCT04675593