Medication Adherence in Hypertensive Individuals With Bipolar Disorder

Completed · Not applicable

Conditions studied: Hypertension, Bipolar Disorder

In brief

This study will test an adherence intervention (iTAB-CV) delivered via interactive text messaging which first targets behavioral intent and then adds cues/reminders and reinforcement to form the habit of taking antihypertensives in non-adherent individuals with BD. Thirty eight individuals with BD and HTN being treated with evidence-based antihypertensive agents and mood stabilizing or antipsychotic medications who are non-adherent with their HTN medicine will be enrolled. This study uses a prospective cohort design with participants serving as their own control. Investigators will test the iTAB-CV intervention quantitatively for feasibility and acceptability as well as for efficacy in increasing adherence to antihypertensives, decreasing systolic blood pressure, and increasing adherence to BD medication.

Key facts

Study ID

NCT02983877

Run by

Case Western Reserve University

People needed

38

Starts

2017-03-13

Expected to finish

2018-06-28

Last updated by the study team

2019-12-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants will have a clinical diagnosis of BD for at least 2 years as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI) (52)
• Have stage 1 or 2 HTN with a systolic pressure ≥130
• Carry a diagnosis of HTN per patient self-report ≥ 6 months prior to enrollment
• Have been prescribed at least one regularly scheduled antihypertensive medication for ≥ 3 months since diagnosis
• Have self-reported poor adherence to antihypertensive medication defined as at least 20% of days with missed doses for at least one antihypertensive in either the past week or past month as identified by the Tablets Routine Questionnaire (TRQ).
• Be able to participate in psychiatric interviews

You may not qualify if…

• Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
• Unable or unwilling to give written, informed consent to study participation
• Under the age of 21
• In the interest of patient safety, individuals who are at high immediate risk for suicide will be excluded from study participation. The suicide risk assessment will be informed by standardized assessments of psychiatric symptoms and the Mini-International Neuropsychiatric Interview (MINI). In the event that a potential study participant is determined to be at high risk for suicide, that individual will not be enrolled and the study staff will immediately implement procedures for the safety of the individual. Once such individuals are deemed stable, they may be once again considered for inclusion in the research.
• Individuals who are monolingual, non-English speaking will be excluded. Given the relatively small sample size in the proposed study, it would not be practical to conduct sub-group analyses. Also, the study assessment tools and the texting intervention are not available in other languages and would be impractical to develop. Based upon our BD adherence work, which drew upon a population similar to the proposed trial, there were no potential subjects who were excluded from the studies due to inability to speak English.
• Illiterate participants will be excluded because reading is an essential skill required to complete self-report questionnaires administered during the study as well as to respond to the text messages which make up the intervention.

Where it is running

• University Hospitals Cleveland Medical Center and Case Western Reserve University — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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