mHealth Technology for High Blood Pressure in Bipolar Disorder

(iTAB-CV RCT Trial)

Overseen By Martha Sajatovic, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must be taking: Antihypertensives, Antidepressants

Disqualifiers: Psychotic, Suicidal, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new technology, iTAB-CV (Individualized Texting for Adherence Building – Cardiovascular), combined with self-monitoring, can help individuals with high blood pressure and either Bipolar Disorder or Major Depressive Disorder adhere better to their medication routines. The goal is to improve medication adherence and lower blood pressure among those who struggle with following their treatment plans. Participants will either use iTAB-CV with self-monitoring or just self-monitoring to assess which method is more effective. Individuals who have difficulty taking their blood pressure medication as prescribed and have been diagnosed with either Bipolar Disorder or Major Depressive Disorder might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment strategies for individuals with complex health conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it seems you need to continue taking your prescribed antihypertensive and, if applicable, antidepressant medications.

What prior data suggests that this mHealth technology is safe for individuals with high blood pressure and bipolar disorder?

Research shows that iTAB-CV, a tech-based program using text reminders, is generally safe. This program does not involve any new drugs or chemicals and helps individuals remember to take their current medications.

Similar studies have found these types of programs well-received, with participants reporting no serious side effects. iTAB-CV sends text messages to remind patients to take their medication and check their blood pressure. This non-invasive approach has been safely used in other health studies.

Since this trial tests a method to help people take their medication regularly, rather than a new drug, the risk of harmful effects is very low. Overall, iTAB-CV is a safe option for those seeking better management of high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iTAB-CV treatment because it introduces a novel approach to managing high blood pressure in individuals with bipolar disorder. Unlike standard treatments that rely solely on medication, iTAB-CV integrates mobile health technology with self-monitoring, allowing patients to track their blood pressure and mood in real-time. This method empowers patients to actively participate in their care, potentially leading to better adherence and outcomes. Additionally, the inclusion of customizable reminders through high and low intensity boosters offers a personalized touch, tailoring the intervention to individual needs. This innovative combination of technology and self-management could transform how high blood pressure is managed in patients with bipolar disorder.

What evidence suggests that this trial's treatments could be effective for high blood pressure in bipolar disorder?

Research has shown that the iTAB-CV program, which uses personalized reminders and self-checks, may help people take their blood pressure medicine more regularly. This trial will evaluate the effectiveness of iTAB-CV combined with self-monitoring, as well as self-monitoring alone. The iTAB-CV method has shown promise in helping people adhere to their medication schedules. By making it easier to remember to take medicine, iTAB-CV could help lower high blood pressure in people with bipolar disorder or major depression. Early results suggest that using technology along with regular self-checks can lead to better health. This approach could be especially useful for managing high blood pressure, which is common in these conditions. ^{1 3 4 6 7}

Who Is on the Research Team?

Jennifer Levin, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have been diagnosed with high blood pressure for at least 6 months.

I own a cell phone capable of receiving text messages.

Exclusion Criteria

Unable/unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales

People who are at high risk for suicide will not be able to join the study because it might not be safe for them. This will be determined by asking questions and doing tests to understand their mental health and if they have any thoughts of hurting themselves. If someone is found to be at risk, they will not be able to join the study, and the study team will help keep them safe. If they are no longer at risk, they can be considered for the study again.

I speak English fluently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants receive an automated device (eCAP) to track their use of antihypertensive medication for 1 month until completing their baseline assessment

1 month

1 visit (in-person or virtual)

Stage 1 Treatment

Participants are randomized to either iTAB-CV + self-monitoring or self-monitoring alone for 2 months with an interim phone/video assessment for adherence

2 months

1 interim phone/video assessment, 1 final assessment (in-person or virtual)

Stage 2 Treatment

Participants in iTAB-CV are re-randomized to receive either a high intensity or low intensity booster + self-monitoring compared to self-monitoring alone

2 months

1 interim phone/video assessment, 1 final assessment (in-person or virtual)

Follow-up

Participants are monitored for adherence and health outcomes without intervention

6 months

1 interim phone/video assessment, 1 final assessment (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• iTAB-CV
• Self-Monitoring

Trial Overview

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.

How Is the Trial Designed?

Group I: iTAB-CV + Self Monitoring - Low Intensity Booster Experimental Treatment 1 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 Booster Experimental Treatment 1 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 Monitoring Experimental Treatment 1 Intervention

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

Group IV: Self Monitoring Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

A pilot study tested a culturally sensitive psychosocial intervention aimed at improving medication adherence and health behaviors in Puerto Rican patients with bipolar disorder and cardiovascular disease risk factors, showing that 71% of participants completed the intervention.

The intervention resulted in significant improvements in medication adherence and reduction in manic symptoms, with effect sizes ranging from medium to large (Cohen's d = 0.52-0.92), indicating its potential efficacy and acceptability among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Psychosocial Intervention to Promote Treatment Adherence in Patients with Bipolar Disorder at Risk of Cardiovascular Disease. Ralat, SI., Alicea-Cuprill, G., Arroyo, Y., et al.[2021]

A multicomponent technology-assisted system for enhancing medication adherence in bipolar disorder was found to be feasible and well-received by patients, with high usability scores reported over a 15-day trial involving five participants.

The system led to improvements in medication adherence, bipolar disorder knowledge, and symptoms, with a notable 40% increase in treatment knowledge scores, although challenges were noted in adapting the system for various pill container types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A technology-enabled adherence enhancement system for people with bipolar disorder: results from a feasibility and patient acceptance analysis. Sajatovic, M., Davis, MS., Cassidy, KA., et al.[2020]

This 5-year randomized controlled trial aims to improve hypertension medication adherence in individuals with bipolar disorder through an interactive text messaging intervention (iTAB-CV), involving 200 participants who will be monitored for 52 weeks.

The study will assess the effectiveness of this intervention on both blood pressure control and adherence to medications, with the potential for scaling up the approach to benefit other populations facing similar adherence challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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, JB., Moore, DJ., Depp, C., et al.[2023]

A focus group study with 13 participants revealed that forgetfulness and mood fluctuations related to bipolar disorder significantly hinder medication adherence for hypertension, highlighting the need for tailored interventions.

Participants responded positively to a proposed text messaging system for medication reminders, suggesting that patient engagement in developing m-health solutions could enhance adherence to treatments for both bipolar disorder and hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Participation in the Development of a Customized M-Health Intervention to Improve Medication Adherence in Poorly Adherent Individuals with Bipolar Disorder (BD) and Hypertension (HTN). Blixen, C., Sajatovic, M., Moore, DJ., et al.[2022]

The study involving 38 participants showed that combining psychoeducation with the automated text messaging intervention (iTAB-CV) significantly improved adherence to antihypertensive medications, reducing nonadherence from 43% to 21% over 12 weeks.

Participants also experienced a significant decrease in systolic blood pressure, from an average of 144.8 mmHg to 136.0 mmHg, indicating that the intervention not only improved adherence but also had a positive impact on health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Psychoeducation and a Text Messaging Adherence Intervention Among Individuals With Hypertension and Bipolar Disorder. Levin, JB., Sajatovic, M., Rahman, M., et al.[2020]

Smartphone applications can significantly enhance the management of hypertension by improving medication adherence, blood pressure control, and promoting lifestyle changes, especially among younger users.

While technology interventions show promise in reducing physical inactivity and obesity, further research is needed to identify the most effective components of these interventions and to make them more accessible for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mobile applications and management of hypertension: possibilities, problems and perspectives]. Becker, S., Mitchell, A., Königsmann, T., et al.[2021]

Latinos with bipolar disorder (BD) experience higher rates of nonadherence to psychiatric medications and treatment for cardiovascular disease (CVD) risk factors compared to non-Latinos, highlighting a significant health disparity.

Focus group discussions with 22 Latino adults revealed distinct barriers to adherence for BD medications versus CVD risk factors, indicating that tailored interventions are necessary to address these specific challenges in treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons for Nonadherence to Psychiatric Medication and Cardiovascular Risk Factors Treatment Among Latino Bipolar Disorder Patients Living in Puerto Rico: A Qualitative Study. Ralat, SI., Depp, CA., Bernal, G.[2019]

Citations

1.

psychiatryonline.org

psychiatryonline.org/doi/10.1176/appi.ps.201800482

Outcomes of Psychoeducation and a Text Messaging ...

This study evaluated the feasibility, acceptability, and preliminary efficacy of psychoeducation plus an automated text messaging ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04675593

Using mHealth to Improve Adherence and Reduce Blood ...

This proposed 2-stage randomized controlled trial (RCT) will evaluate a personalized patient-centered adherence intervention iTAB-CV + Self-Monitoring ...

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researchgate.net

researchgate.net/publication/361627436_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

study protocol for a 2-stage randomized clinical trial

The primary outcomes are systolic blood pressure and adherence to antihypertensive medication as determined by a self-reported questionnaire and ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35768875/

study protocol for a 2-stage randomized clinical trial - PubMed

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pmc.ncbi.nlm.nih.gov

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study protocol for a 2-stage randomized clinical trial - PMC

Using mHealth to improve adherence and reduce blood pressure in individuals with hypertension and bipolar disorder (iTAB-CV): study protocol for ...

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reporter.nih.gov

reporter.nih.gov/project-details/10837895

Project Details - NIH RePORTER

This project will be conducted as a 12-month prospective 2-stage randomized controlled trial comparing iTAB-CV + Self-Monitoring of blood pressure, mood, and ...

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uhhospitals.org

uhhospitals.org/uh-research/find-clinical-trials-and-studies/clinical-trials-search/itab-cv-rct-3309

iTAB-CV Study for Hypertension and Biopolar Disorder

The purpose of this research is to evaluate a brief, practical adherence intervention (iTAB-CV) delivered via interactive text messaging+ Self-Monitoring (SM)