mHealth Technology for High Blood Pressure in Bipolar Disorder

(iTAB-CV RCT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jennifer Levin, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Case Western Reserve University

Must be taking: Antihypertensives, Antidepressants

Disqualifiers: Psychotic, Suicidal, Non-English, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment iTAB-CV for high blood pressure in individuals with bipolar disorder?

Research shows that a similar intervention combining psychoeducation and automated text messaging (iTAB-CV) improved medication adherence in individuals with both hypertension and bipolar disorder. Additionally, a psychosocial intervention for bipolar patients at risk of cardiovascular disease showed improvements in medication adherence and symptoms, suggesting that such approaches can be effective. ^{1 2 3 4 5}

Is the mHealth technology for high blood pressure in bipolar disorder safe for humans?

The studies reviewed focus on the feasibility and acceptability of the mHealth intervention, but they do not report any specific safety concerns or adverse effects, suggesting it is generally safe for use in humans. ^{1 2 3 5 6}

How is the iTAB-CV treatment different from other treatments for high blood pressure in bipolar disorder?

The iTAB-CV treatment is unique because it uses personalized text messages to help people with bipolar disorder remember to take their blood pressure medication, which is different from traditional treatments that don't use technology to improve medication adherence. ^{1 2 3 5 7}

Research Team

Jennifer Levin, PhD

Principal Investigator

Case Western Reserve University

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• iTAB-CV (Behavioral Intervention)
• Self-Monitoring (Behavioral Intervention)

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.

Participant Groups

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+

Eric W. Kaler

Case Western Reserve University

Chief Executive Officer since 2021

PhD in Chemical Engineering from the University of Minnesota

Stanton L. Gerson

Case Western Reserve University

Chief Medical Officer since 2020

MD from Harvard Medical School

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Psychoeducation and a Text Messaging Adherence Intervention Among Individuals With Hypertension and Bipolar Disorder. [2020]

2. United States 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). [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

A technology-enabled adherence enhancement system for people with bipolar disorder: results from a feasibility and patient acceptance analysis. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Development of a Psychosocial Intervention to Promote Treatment Adherence in Patients with Bipolar Disorder at Risk of Cardiovascular Disease. [2021]

5. England 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. [2023]

6. United States 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. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

[Mobile applications and management of hypertension: possibilities, problems and perspectives]. [2021]