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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 9 and month 12

Awards & highlights

iTAB-CV RCT Trial Summary

This trial will compare a technology-based intervention to improve adherence to blood pressure medication in people with bipolar disorder to just monitoring 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.Check my eligibility

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.See study design

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.

iTAB-CV RCT Trial Eligibility Criteria

Inclusion Criteria

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

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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.

iTAB-CV RCT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Change in systolic blood pressure (SBP)

Change in the Tablet Routine Questionnaire (TRQ)

Secondary outcome measures

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

iTAB-CV RCT 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor

299 Previous Clinical Trials

259,897 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,836 Previous Clinical Trials

47,850,657 Total Patients Enrolled

University of California, San DiegoOTHER

1,120 Previous Clinical Trials

1,521,207 Total Patients Enrolled

Media Library

iTAB-CV Clinical Trial Eligibility Overview. Trial Name: NCT04675593 — N/A

High Blood Pressure Research Study Groups: iTAB-CV + Self Monitoring, Self Monitoring, iTAB-CV + Self Monitoring - High Intensity Booster, iTAB-CV + Self Monitoring - Low Intensity Booster

High Blood Pressure Clinical Trial 2023: iTAB-CV Highlights & Side Effects. Trial Name: NCT04675593 — N/A

iTAB-CV 2023 Treatment Timeline for Medical Study. Trial Name: NCT04675593 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are contributing to this clinical experiment?

"Affirmative, according to the information provided on clinicaltrials.gov this trial remains open for recruitment and was initially posted on March 15th 2021 with a last edit date of July 22nd 2022. The study is currently searching for 200 individuals to participate at one location."

Answered by AI

What are the aims of this clinical trial?

"This clinical trial will use the Tablet Routine Questionnaire (TRQ) to evaluate its primary objective. As a secondary measure of success, researchers are looking at changes in self-efficacy for medication taking behavior as measured by MASES-R, levels of depression via MADRS score, and BMQ scores which gauge patients' beliefs about medications over baseline and Month 4 timeframes."

Answered by AI

Is the research study recruiting individuals aged 45 or older?

"Patients aged between 21 and 80 are currently being sought for this medical trial."

Answered by AI

Do I satisfy the prerequisites to partake in this medical study?

"In order to be accepted into this clinical study, potential participants should have an existing history of nonadherence and are required to fall between the ages of 21-80. The trial is aiming for 200 enrollees in total."

Answered by AI

Are there vacancies available in this clinical trial?

"The clinical trial is actively enrolling participants. According to the information available on clinicaltrials.gov, recruitment commenced in mid-March 2021 and was last edited at the end of July 2022."

Answered by AI

Recent research and studies

TrialsJournal

Using Mhealth to Improve Adherence and Reduce Blood Pressure in Individuals with Hypertension and Bipolar Disorder (itab-cv): Study Protocol for a 2-stage Randomized Clinical Trial

Levin, Jennifer B., David J. Moore, Colin Depp, Jessica L. Montoya, Farren Briggs, Mahboob Rahman, Kurt C. Stange, et al.. 2022. “Using Mhealth to Improve Adherence and Reduce Blood Pressure in Individuals with Hypertension and Bipolar Disorder (itab-cv): Study Protocol for a 2-stage Randomized Clinical Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06449-9.

clinicaltrials.govStudy

Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Bipolar Disorder

Jennifer Levin 2021. "Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04675593.

All > Blood Pressure > Bipolar Disorder