Medication Adherence in Hypertensive Individuals With Bipolar Disorder

NCT02983877 | Completed Results DMC

• 1 other identifier: HL132364
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

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

  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.

  change from Screen (Week 0) to V2 (week 12)

Secondary Outcomes (3)

• 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)

• Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP)

  change from Baseline (Week 4) to V2 (week 12)

Study Arms (1)

iTAB-CV

EXPERIMENTAL

In the Individualized Texting for Adherence Building-CV (iTAB-CV) Stage 1, participants will receive alternating daily texts with educational and motivational content on treatment for high blood pressure and bipolar disorder, and a daily mood rating request to both monitor their mood and to determine adherence to iTAB-CV intervention. Stage 1 will last one month. In the Individualized Texting for Adherence Building-CV (iTAB-CV) Stage 2, 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. Stage 2 will last one month.

Behavioral: iTAB-CV

Interventions

iTAB-CV BEHAVIORAL

Stage 1 of the 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, participants will receive alternating daily texts with educational and motivational content and a daily mood rating request to both monitor their mood and to determine adherence to the intervention. In the second stage for the following month, 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.

Also known as: Individualized Texting for Adherence Building-CV

iTAB-CV

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

University Hospitals Cleveland Medical Center and Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Levin JB, Sajatovic M, Rahman M, Aebi ME, Tatsuoka C, Depp C, Cushman C, Johnston E, Cassidy KA, Blixen C, Eskew L, Klein PJ, Fuentes-Casiano E, Moore DJ. Outcomes of Psychoeducation and a Text Messaging Adherence Intervention Among Individuals With Hypertension and Bipolar Disorder. Psychiatr Serv. 2019 Jul 1;70(7):608-612. doi: 10.1176/appi.ps.201800482. Epub 2019 Apr 17.

  PMID: 30991908 DERIVED

MeSH Terms

Conditions

Hypertension; Bipolar Disorder

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jennifer Levin
• Organization: Case Western Reserve University

jennifer.levin@uhhospitals.org

2168445057

Study Officials

• Jennifer Levin, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Following a 30 day run-in period, Stage 1 of the iTAB-CV intervention will be introduced. A member of the study team 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.

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 6, 2016
• Study Start: March 13, 2017
• Primary Completion: June 4, 2018
• Study Completion: June 28, 2018
• Last Updated: December 9, 2019
• Results First Posted: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)