mHealth Technology for High Blood Pressure in Bipolar Disorder
(iTAB-CV RCT Trial)
Recruiting in Palo Alto (17 mi)
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.12345
Is the mHealth technology for high blood pressure in bipolar disorder safe for humans?
How is the iTAB-CV treatment different from other treatments for high blood pressure in bipolar disorder?
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.
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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.
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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 OverviewThe 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
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Case Western Reserve UniversityCleveland, OH
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Who Is Running the Clinical Trial?
Case Western Reserve UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
University of California, San DiegoCollaborator
References
Outcomes of Psychoeducation and a Text Messaging Adherence Intervention Among Individuals With Hypertension and Bipolar Disorder. [2020]This study evaluated the feasibility, acceptability, and preliminary efficacy of psychoeducation plus an automated text messaging intervention (Individualized Texting for Adherence Building-Cardiovascular [iTAB-CV]) to improve adherence to antihypertensives and bipolar disorder medication.
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]Individuals living with bipolar disorder (BD) have poorer management of chronic medical conditions such as hypertension (HTN), and worse treatment adherence than the general population. The study objective was to obtain information from patients with both BD and HTN that would inform the development of an m-Health intervention to improve medication adherence for poorly adherent individuals living with both these chronic illnesses.
A technology-enabled adherence enhancement system for people with bipolar disorder: results from a feasibility and patient acceptance analysis. [2020]As poor medication adherence is common in bipolar disorder (BD), technology-assisted approaches may help to monitor and enhance adherence. This study evaluated preliminary feasibility, patient satisfaction and effects on adherence, BD knowledge, and BD symptoms associated with the use of a multicomponent technology-assisted adherence enhancement system.
Development of a Psychosocial Intervention to Promote Treatment Adherence in Patients with Bipolar Disorder at Risk of Cardiovascular Disease. [2021]Nonadherence to treatment is a serious concern that affects the successful management of bipolar disorder (BD) patients. The aim of this study was to pilot test a psychosocial intervention (previously developed by this team) intended to increase adherence to medication and health behaviors targeting cardiovascular disease (CVD) risk factors in BD patients. An open, single-group design was used to assess the feasibility and acceptability of the intervention. The participants had BD, type I/II or unspecified, and CVD risk factors. Baseline demographic measures were taken. We also obtained preliminary effect sizes related to pre-post changes on measures of self-reported adherence to psychiatric medication, depressive and manic symptoms, and pharmacy records. At baseline, 29% of the participants reported recent adherence to psychiatric medications. A total of 71% of the participants completed the intervention. Pre-post improvements by medium and large effect sizes (Cohen's d = 0.52-0.92) were seen in medication adherence, attitudes toward medication, and mania symptoms. The participants reported high levels of satisfaction with the intervention. A culturally sensitive psychosocial intervention for Puerto Rican BD patients who are at risk of CVD was found to be feasible and acceptable. Improvements in the key outcomes were seen in this small, preliminary study. Further research is needed with a larger sample size.
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]Cardiovascular disease in individuals with mental health conditions such as bipolar disorder is highly prevalent and often poorly managed. Individuals with bipolar disorder face significant medication adherence barriers, especially when they are prescribed multiple medications for other health conditions including hypertension. Poor adherence puts them at a disproportionate risk for poor health outcomes. As such, there is a need for effective interventions to improve hypertension medication adherence, particularly in patients that struggle with adherence due to mental health comorbidity.
Reasons for Nonadherence to Psychiatric Medication and Cardiovascular Risk Factors Treatment Among Latino Bipolar Disorder Patients Living in Puerto Rico: A Qualitative Study. [2019]Latinos with bipolar disorder (BD) have a high rate of nonadherence to psychiatric medication and treatment for other medical conditions such as cardiovascular disease (CVD) risk factors than non-Latinos with BD. The aim of this study is to identify patients' perspectives on the reasons for nonadherence to psychiatric medication and for CVD risk factors conditions in outpatients with BD. Three focus group sessions were held for a total of 22 adults ranging from 23 to 60 years old. Participants had BD, Type I/II and CVD risk factors. Audio-recordings of focus groups were transcribed and a content analysis was performed. Reasons identified as barriers to adherence were somewhat different for BD medications in comparison to CVD risk factors suggesting the need for integrated interventions targeting these barriers to adherence for both BD and CVD risk factors.
[Mobile applications and management of hypertension: possibilities, problems and perspectives]. [2021]Via the internet smartphones allow the download of applications ("Apps") that can address various requirements of daily life. These technical advances create new opportunities to better meet needs of patients suffering from hypertension. This may apply particularly for medication adherence, blood pressure control and lifestyle-changing activities. At the moment younger users in particular are interested in such technology. From other clinical contexts it is known that text messages via cell phones improve medication adherence. A combination of a smartphone and a blood pressure measurement device with the possibility to electronically collect data is promising as the quality of data may improve. Technology interventions by mobile applications that are supported by education or an additional intervention demonstrate a beneficial impact for the reduction of physical inactivity and/or overweight and obesity. However, it is not clear what parts of the technology or interventions are effective. For future developments it will be important to reduce costs and better meet hardware and software requirements of elderly users.