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.
Is the treatment iTAB-CV a promising treatment for high blood pressure in people with bipolar disorder?Yes, iTAB-CV is a promising treatment because it uses personalized text messages to help people remember to take their medication, which can improve their health by managing both high blood pressure and bipolar disorder more effectively.12457
What safety data exists for mHealth treatment for high blood pressure in bipolar disorder?The available research primarily focuses on the feasibility, acceptability, and preliminary efficacy of the mHealth intervention, specifically the iTAB-CV system, for improving medication adherence in individuals with hypertension and bipolar disorder. While these studies assess feasibility and patient satisfaction, they do not explicitly provide detailed safety data. The intervention is generally aimed at improving adherence and managing symptoms, but specific safety outcomes are not highlighted in the provided abstracts.23457
What data supports the idea that mHealth Technology for High Blood Pressure in Bipolar Disorder is an effective treatment?The available research shows that mHealth Technology, specifically the iTAB-CV system, is promising for improving medication adherence in individuals with both high blood pressure and bipolar disorder. One study found that participants using a technology-assisted system reported improvements in sticking to their medication schedules and had better knowledge about their condition. Another study highlighted that a similar intervention led to medium to large improvements in medication adherence and symptoms of mania. These findings suggest that mHealth Technology can help people manage their conditions more effectively compared to traditional methods.24567
Do I need to stop my current medications to join the trial?The trial does not specify if you need to stop your current medications. However, you must be on antihypertensive medication and, if you have MDD, an antidepressant. It seems likely you can continue your current medications.
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 on blood pressure medication for over 3 months.
I have been diagnosed with Bipolar Disorder through the MINI interview.
I am between 21 and 80 years old.
Exclusion Criteria
My upper arm is thicker than 50cm.
Treatment Details
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.
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
[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.
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.
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.
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.
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.
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.