Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and… (NCT04675593) | Clinical Trial Compass
CompletedNot Applicable
Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Mood Disorders
United States176 participantsStarted 2021-03-15
Plain-language 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.
Who can participate
Age range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age range: from 21 to 80
* Have a clinical diagnosis of either Bipolar Disorder or Major Depressive Disorder as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)
* Have elevated systolic blood pressure ≥130 at screening at least 2 different times during the screening period
* 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
* Have difficulty with adherence to prescribed antihypertensive medication currently or in the past based on one of the following questions: Do you ever miss doses of your prescribed medications for high blood pressure? Or b. Do you ever try to manage your 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 the intervention
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on people with both hypertension and a mood disorder like bipolar disorder or major depressive disorder — given my specific diagnoses, would the approach studied here, using a smartphone app to improve medication-taking habits, be something worth trying in my care plan?
2The trial tracked medication adherence using an electronic monitoring device called eCAP as well as a questionnaire called the Tablet Routine Questionnaire — do you know whether the results showed meaningful improvements in how consistently participants took their medications, and how does that compare to what I'm currently doing?
3Since this trial is completed and was listed as Phase NA, meaning it was more of a behavioral or technology-based study than a drug trial, are the mHealth tools or strategies tested here already available to me, and could we incorporate something similar into my treatment?
4The study measured changes in systolic blood pressure alongside medication adherence — does the evidence from this kind of study suggest that improving how regularly I take my medications could make a real difference in controlling my blood pressure, given that I'm also managing a mood disorder?
5Managing both a mood disorder and hypertension can be complicated, especially when it comes to staying on top of multiple medications — are there other approaches, like pharmacy support, behavioral coaching, or reminders, that you'd recommend alongside or instead of a smartphone-based tool like the one in this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Tablet Routine Questionnaire (TRQ)
Timeframe: Baseline and Month 4
2
Change in systolic blood pressure (SBP)
Timeframe: Baseline and Month 4
3
Change in Adherence based on the Electronic Monitoring Device (eCAP)