Medication Adherence in Hypertensive Individuals With Bipolar Disorder

Status Completed

Clinical Trial Summary

Clinical Trial Description

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.

All study participants will be followed for a 3-month period. iTAB-CV, delivered via mobile phone, is intended to be a brief adjunct to standard primary care and mental health treatment. All individuals will continue to receive treatment as usual with their regular provider(s). Individuals who meet eligibility criteria will have a 30 day run-in period in which their medication adherence will be measured with TRQ and MEMS but without an additional intervention. Following the run-in period, Stage 1 of the iTAB-CV intervention will be introduced. Researchers will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month of iTAB-CV, participants will receive alternating daily texts with psychoeducational and motivational content once daily and a daily mood rating request to both monitor their mood and to determine engagement with the iTAB-CV intervention. In the second stage of iTAB-CV, participants will receive daily texts which will include medication reminders, contextual cues, and immediate reinforcement for medication taking behavior in addition to the content from stage 1.

Assessments that include evaluation of treatment adherence, psychiatric symptoms, self-efficacy for medication taking behavior, illness beliefs, medication attitudes, and habit strength for both antihypertensive and BD medications will be conducted at four time points over a 3-month time period (screening, baseline/week 4, week 8, and week 12). Blood pressure will be measured at each of the four contacts. Individuals who drop out of the intervention, and who agree, will be followed up with outcomes assessments over the same 3-month time period that they would have been evaluated had they remained in the study.

About one month after study completion, a member of the research team will call each participant and ask questions about their bipolar and blood pressure medication taking habits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02983877
Study type	Interventional
Source	Case Western Reserve University
Contact
Status	Completed
Phase	N/A
Start date	March 13, 2017
Completion date	June 28, 2018

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04591808` - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia	Phase 3
Recruiting	`NCT04515303` - Digital Intervention Participation in DASH
Completed	`NCT05433233` - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension	N/A
Completed	`NCT05491642` - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses	Phase 1
Completed	`NCT03093532` - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT05529147` - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting	`NCT06363097` - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Recruiting	`NCT05976230` - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Completed	`NCT06008015` - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers	Phase 1
Completed	`NCT05387174` - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period	N/A
Completed	`NCT04082585` - Total Health Improvement Program Research Project
Recruiting	`NCT05121337` - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension	N/A
Withdrawn	`NCT04922424` - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men	Phase 1
Active, not recruiting	`NCT05062161` - Sleep Duration and Blood Pressure During Sleep	N/A
Not yet recruiting	`NCT05038774` - Educational Intervention for Hypertension Management	N/A
Completed	`NCT05087290` - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed	`NCT05621694` - Exploring Oxytocin Response to Meditative Movement	N/A
Completed	`NCT05688917` - Green Coffee Effect on Metabolic Syndrome	N/A
Recruiting	`NCT05575453` - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure	N/A

Medication Adherence in Hypertensive Individuals With Bipolar Disorder — iTAB-CV

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms