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Clinical Trials/NCT02983877
NCT02983877
Completed
Not Applicable

Improving Medication Adherence in Hypertensive Individuals With Bipolar Disorder

Case Western Reserve University1 site in 1 country38 target enrollmentMarch 13, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Case Western Reserve University
Enrollment
38
Locations
1
Primary Endpoint
Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 13, 2017
End Date
June 28, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Levin

Associate Professor

Case Western Reserve University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ)

Time Frame: change from Screen (Week 0) to V2 (week 12)

This self-report measure identifies non-adherence for the past 7 days (Scott \& Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence will be assessed for each regularly scheduled antihypertensive that has been prescribed for ≥ 3 months. For individuals who are on more than one medication, an average TRQ will be calculated for all antihypertensive medications. PRN medications will not be included.

Secondary Outcomes

  • Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP)(change from Baseline (Week 4) to V2 (week 12))
  • Change in Systolic Blood Pressure(change from Screen (Week 0) to V2 (week 12))
  • Change in Adherence to Bipolar Medication Based on the Tablets Routine Questionnaire (TRQ)(change from Screen (Week 0) to V2 (week 12))

Study Sites (1)

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