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Principal Investigator: Jennifer Beth Levin
Organization: CASE WESTERN RESERVE UNIVERSITY
Fiscal Year: 2024
Award: $714,215
Funding agency: National Heart Lung and Blood Institute
PROJECT SUMMARY
While cardiovascular disease remains a significant burden in the U.S., effects are particularly pronounced in
people with mental disorders such as bipolar disorder (BD). Medical complications and early mortality in those
with BD and hypertension is often associated with poor medication adherence and sub -optimal engagement in
care. However, medication non-adherence among such individuals and its negative impact on both
cardiovascular and mental health is a potentially modifiable problem of critical public health importance. The
proposed study, written in response to PA-18-722: Improving Patient Adherence to Treatment and Prevention
Regimens to Promote Health, will evaluate the effects of a personalized patient-centered adherence m-Health
intervention called Individualized Texting for Adherence Building-Cardiovascular; iTAB-CV (iTAB-CV) on
adherence to antihypertensive medications and systolic blood pressure in people with BD.
In common with many individuals with mood symptoms, BD patients have cognitive and functional
impairment that need adherence approaches that go above and beyond standard education. Effective
approaches should help engagement in care for both physical and mental health. iTAB-CV is delivered on a
mobile phone via Short Message Service (SMS) and is based on a modified version of the Attitude -Social
Influence-Efficacy (ASE) model to target both intentional and non-intentional non-adherence. To change and
sustain adherence in this and similar populations, one must address attitudes, self-efficacy, and prospective
memory deficits to form the habit of medication taking. In a pilot trial of iTAB-CV, participants were highly
engaged, with 100% retention over 3 months and showed significant improvement in adherence, reduction in
systolic blood pressure (SBP), and improved psychiatric symptoms. 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 medication taking (n=100) to Self-Monitoring alone (n=100). The primary outcome is adherence to
antihypertension medication as measured by the self-reported Tablets Routine Questionnaire (TRQ) and
validated with objective automated pill caps (eCAP) and systolic blood pressure while secondary outcomes
include adherence to psychiatric medication and psychiatric symptoms. iTAB-CV participants will be re-
randomized to low and high frequency booster sessions to explore whether dose (frequency of text) moderates
longer-term outcome, to investigate habit strength as a mediator of adherence and identify variables that
enhance or impede adherence. We will also employ an advisory board made up of key stakeholders including
patients, family members, providers, and administrative staff who can help inform how the intervention might fit
into existing clinical workflows. iTAB-CV has potential to advance care for people with poorly controlled
hypertension and mental health comorbidity. The practical, m-Health delivery format will enhance suitability for
broad scale-up in future hybrid implementation-effectiveness trials.
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