What side effects are associated with this type of intervention?

Common treatments for high blood pressure include ACE inhibitors, ARBs, calcium channel blockers, beta-blockers, and diuretics. ACE inhibitors and ARBs can cause cough, elevated blood potassium levels, and kidney dysfunction. Calcium channel blockers may lead to swelling in the lower extremities, dizziness, and constipation. Beta-blockers can cause fatigue, cold extremities, and bradycardia. Diuretics often result in increased urination, electrolyte imbalances, and dehydration. These side effects can impact patient adherence, which is a focus of the iTAB-CV trial aiming to improve medication adherence through personalized, technology-facilitated interventions.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure, including ACE inhibitors, ARBs, calcium channel blockers, and beta-blockers. These medications are commonly used to manage hypertension and reduce cardiovascular risk. In addition to pharmacologic treatments, technology-facilitated interventions like the iTAB-CV trial, which focuses on personalized patient-centered adherence through digital health tools, are being studied to improve medication adherence and blood pressure control. While specific FDA approvals for such digital interventions are not detailed, their use is gaining recognition in chronic disease management.

What other types of research exist?

Promising alternatives to iTAB-CV for high blood pressure patients include: 1) mHealth applications that integrate self-monitoring with personalized feedback, 2) Fixed-dose combination (FDC) therapies to simplify medication regimens and improve adherence, 3) Bedtime hypertension chronotherapy (BTCT) which targets normalization of asleep blood pressure, and 4) Telehealth platforms for continuous monitoring and management of blood pressure.

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mHealth Technology for High Blood Pressure in Bipolar Disorder (iTAB-CV RCT Trial)

N/A

Recruiting

Led By Jennifer Levin, PhD

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Have a clinical diagnosis of Bipolar Disorder as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)

Must not have

Upper arm circumference > 50cm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 9 and month 12

Awards & highlights

Summary

This trial tests if text message reminders combined with self-checks can help people with high blood pressure and Bipolar Disorder take their medicine more regularly. The goal is to see if this method works better than just doing self-checks alone.

Who is the study for?

This trial is for adults aged 21-80 with high blood pressure and bipolar disorder who have trouble sticking to their blood pressure medication. They must own a cell phone, have been diagnosed with hypertension at least 6 months ago, and be on antihypertensive meds for over 3 months. People can't join if they're unable or unwilling to do psychiatric interviews, are at high risk of suicide, have an upper arm circumference >50cm, or don't speak English.

What is being tested?

The study tests whether a personalized adherence intervention using mobile health technology (iTAB-CV + Self-Monitoring) is more effective than self-monitoring alone in improving medication adherence and reducing systolic blood pressure among those poorly adherent to antihypertensive drugs.

What are the potential side effects?

Since the interventions involve mHealth technology and self-monitoring rather than medications or invasive procedures, side effects may not be as common as in drug trials. However, potential issues could include stress or anxiety from regular monitoring and data privacy concerns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been on blood pressure medication for over 3 months.

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I have been diagnosed with Bipolar Disorder through the MINI interview.

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I am between 21 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My upper arm is thicker than 50cm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 9 and month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 9 and month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 9 and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Adherence based on the Electronic Monitoring Device (eCAP)

Change in systolic blood pressure (SBP)

Change in the Tablet Routine Questionnaire (TRQ)

Secondary study objectives

Change in Attitude towards Medication Questionnaire (AMSQ) score

Change in Beliefs About Medicines Questionnaire (BMQ) score

Change in Montgomery Asberg Rating Scale (MADRS) score

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: iTAB-CV + Self Monitoring - Low Intensity BoosterExperimental Treatment1 Intervention

Following the 4-month assessment, subjects in the iTAB-CV group will be re-randomized to receive either a high intensity booster or low intensity booster. Those in the low intensity booster group will receive 1 reminder per week for 2 months, in addition to self monitoring.

Group II: iTAB-CV + Self Monitoring - High Intensity BoosterExperimental Treatment1 Intervention

Following the 4-month assessment, subjects in the iTAB-CV group will be re-randomized to receive either a high intensity booster or low intensity booster. Those in the high intensity booster group will start off receiving 1 reminder per day and taper down to 1 reminder per week over 2 months, in addition to self monitoring.

Group III: iTAB-CV + Self MonitoringExperimental Treatment1 Intervention

Receives iTAB-CV intervention plus self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating

Group IV: Self MonitoringActive Control1 Intervention

Receives self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

iTAB-CV

2017

N/A

~40

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include ACE inhibitors, ARBs, calcium channel blockers, and thiazide diuretics. ACE inhibitors and ARBs work by relaxing blood vessels through the inhibition of the renin-angiotensin system, reducing blood pressure. Calcium channel blockers prevent calcium from entering heart and blood vessel cells, leading to relaxed vessels and lower blood pressure. Thiazide diuretics help the kidneys remove excess sodium and water, decreasing blood volume and pressure. Effective management of high blood pressure is crucial to prevent complications such as stroke and heart disease. Interventions like iTAB-CV, which use technology to enhance medication adherence, are vital as they ensure patients consistently take their medications, thereby maintaining optimal blood pressure control and reducing the risk of adverse cardiovascular events.

Determinants of hypertension treatment adherence among a Chinese population using the therapeutic adherence scale for hypertensive patients.Understanding the quality chasm for hypertension control in diabetes: a structured review of "co-maneuvers" used in clinical trials.Meta-analysis of interventions for medication adherence to antihypertensives.