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.

BACKGROUND: 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. METHODS: This 5-year project uses a 2-stage randomized controlled trial design to evaluate a brief, practical adherence intervention delivered via interactive text messaging (iTAB-CV) along with self-monitoring of medication taking, mood, and home blood pressure (N = 100) compared to self-monitoring alone (N = 100). Prior to randomization, all participants will view an educational video that emphasizes the importance of medication for the treatment of hypertension and bipolar disorder. Those randomized to the texting intervention will receive daily text messages with predetermined content to address 11 salient domains as well as targeted customized messages for 2 months. This group will then be re-randomized to receive either a high (gradual taper from daily to weekly texts) or low booster (weekly texts) phase for an additional 2 months. All participants will be monitored for 52 weeks. The primary outcomes are systolic blood pressure and adherence to antihypertensive medication as determined by a self-reported questionnaire and validated with an automated pill-monitoring device. Secondary outcomes include adherence to bipolar disorder medications, psychiatric symptoms, health status, self-efficacy for medication-taking behavior, illness beliefs, medication attitudes, and habit strength. DISCUSSION: This study specifically targets blood pressure and mental health symptom control in people with bipolar and includes implementation elements in the study design intended to inform future scale-up. Promising pilot data and a theoretical model, which views sustained medication-taking behavior in the context of habit formation, suggests that this remotely delivered intervention may help advance care for this high-risk population and is amenable to both scale up and easy adaptation for other groups with poor medication adherence. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov ( NCT04675593 ) on December 19, 2020.

Effective engagement of a stakeholder advisory board in severe mental illness (SMI) research: A case study of a clinical trial to improve adherence among people with SMI and hypertension.

Objective: Poor adherence to antihypertensive medication occurs in 50-80% of patients. An ongoing randomized controlled trial (RCT) is evaluating a personalized mobile-health intervention in poorly adherent hypertensive persons with bipolar disorder. To enhance efficacy, the ongoing trial elicited guidance from a Stakeholder Advisory Board (SAB) comprised of patients, family members, clinicians, and health system administrators. Our goal is to describe the formation, role, decision-making process, and key contributions of the SAB as a means of demonstrating meaningful community engagement in mental health research. Methods: Using models and measures from the field of implementation science, eleven SAB members convened across three meetings followed by quantitative surveys that assessed SAB member satisfaction and engagement during the meeting. Results: Significant suggestions from the SAB included 1) expanding inclusion/exclusion criteria, and 2) operationalizing remote implementation of the RCT. Primary study implementation challenges identified by the SAB were 1) participant difficulty engaging in the mHealth intervention, and 2) identification of procedures for monitoring participant adherence to the RCT protocol and contacting under-engaged participants. Quantitative surveys indicated that all SAB members believed that the objectives of the meetings were clear, perceived that they were able to participate in the discussions, and that they were heard. Conclusions: Increasing evidence demonstrates the feasibility of engaging with SABs in clinical research and that this process improves intervention design, increases participant engagement, reduces mental health-related stigma, and produces more effective implementation strategies. We encourage future investigators to use an implementation science framework in partnership with SABs to refine their proposed interventions and improve clinical outcomes.