Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Mood Disorders

NCT04675593 | Active Not Recruiting DMC

• 2 other identifiers: STUDY202003301R01HL149409-01A1
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

This proposed 2-stage randomized controlled trial (RCT) will evaluate a personalized patient-centered adherence intervention iTAB-CV + Self-Monitoring (iTAB-CV + SM) vs. Self-Monitoring (SM) alone in poorly adherent hypertensive persons with BD or MDD. This practical, technology-facilitated intervention has potential to improve adherence to antihypertensive medication and reduce SBP among high-risk individuals. The intervention is suitable for primary care or mental health settings and has potential for broad scale-up.

Conditions

Bipolar Disorder; Non-Adherence, Medication; Hypertension; Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• Change in the Tablet Routine Questionnaire (TRQ)

  The TRQ item is a subject report of the percentage of prescribed medications not taken within the past month.

  Baseline and Month 4

• Change in systolic blood pressure (SBP)

  Systolic blood pressure indicates how much pressure your blood is exerting against your artery walls when the heart beats. Higher reading implies more pressure

  Baseline and Month 4

• Change in Adherence based on the Electronic Monitoring Device (eCAP)

  Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used for the antihypertensive medication that the patient missed the most frequently in the past week (in the case of multiple antihypertensive medications missed the same proportion of times, the medication dosed most often will be chosen). A dose will be counted as "taken" if the bottle is opened within six hours of the prescribed time. We will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.

  Baseline and Month 4

Secondary Outcomes (6)

• Change in Montgomery Asberg Rating Scale (MADRS) score

  Month 4 and Month 6

• Change in engagement with iTAB intervention

  Month 4 and Month 6

• Change in Beliefs About Medicines Questionnaire (BMQ) score

  Month 4 and Month 6

• Change in Attitude towards Medication Questionnaire (AMSQ) score

  Month 4 and Month 6

• Change in Self-efficacy for Medication Taking Behavior (MASES-R)

  Month 4 and Month 6

Study Arms (4)

iTAB-CV + Self Monitoring

EXPERIMENTAL

Receives iTAB-CV intervention plus self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating

Behavioral: iTAB-CV

Self Monitoring

ACTIVE COMPARATOR

Receives self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating

Behavioral: Self-Monitoring

iTAB-CV + Self Monitoring - High Intensity Booster

EXPERIMENTAL

Following the 4-month assessment, subjects in the iTAB-CV group will be re-randomized to receive either a high intensity booster or low intensity booster. Those in the high intensity booster group will start off receiving 1 reminder per day and taper down to 1 reminder per week over 2 months, in addition to self monitoring.

Behavioral: iTAB-CV

iTAB-CV + Self Monitoring - Low Intensity Booster

EXPERIMENTAL

Following the 4-month assessment, subjects in the iTAB-CV group will be re-randomized to receive either a high intensity booster or low intensity booster. Those in the low intensity booster group will receive 1 reminder per week for 2 months, in addition to self monitoring.

Behavioral: iTAB-CV

Interventions

iTAB-CV BEHAVIORAL

Individualized Texting for Adherence Building - Cardiovascular (iTAB-CV): a personalized patient-centered text message-based adherence intervention

iTAB-CV + Self Monitoring; iTAB-CV + Self Monitoring - High Intensity Booster; iTAB-CV + Self Monitoring - Low Intensity Booster

Self-Monitoring BEHAVIORAL

The Self-Monitoring (control) group will monitor their medication adherence, take their blood pressure weekly with a home blood pressure monitor provided by the study after being trained by the study staff, and rate their mood weekly in response to a text reminder.

Self Monitoring

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: from 21 to 80
• Have a clinical diagnosis of either Bipolar Disorder or Major Depressive Disorder as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)
• Have elevated systolic blood pressure ≥130 at screening at least 2 different times during the screening period
• Have received a diagnosis of hypertension per patient self-report at least 6 months prior to enrollment
• Have been prescribed at least one regularly scheduled antihypertensive medicine for 3 or more months since diagnosis
• Have difficulty with adherence to prescribed antihypertensive medication currently or in the past based on one of the following questions: Do you ever miss doses of your prescribed medications for high blood pressure? Or b. Do you ever try to manage your high blood pressure on your own without medication?
• For those with MDD, currently being prescribed an antidepressant medication
• Have their own cellular phone in order to receive text messages as part of the intervention

You may not qualify if:

• Unable/unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
• Unable/unwilling to give written, informed consent to study participation
• 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, the Mini-International Neuropsychiatric Interview (MINI), and the Montgomery Asberg Depression Rating Scale (MADRS). Individuals with active suicidal ideation and recent suicide attempt or current intent and plan will be excluded from study participation. Individuals who score a ≥ 5 on item 10 of the MADRS will be considered to be at high risk for suicide, although individuals with MADRS scores lower than 5 could potentially be excluded if either the psychologist or psychiatrist PIs believe that the individual is at high immediate risk for suicide based upon other input or information. 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 that individual is no longer at risk, they may be rescreened for possibility enrollment in the study
• Individuals who are monolingual, non-English speaking will be excluded. Given the proposed sample sizes of the iTAB-CV + SM and SM alone treatment arms in the proposed study, it would not be practical to conduct sub-group analyses. Based upon our BD adherence work and RCT, 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. Hispanic individuals made up 3.6% of those enrolled
• Upper arm circumference \> 50cm

Sponsors & Collaborators

• Case Western Reserve University: lead
• University of California, San Diego: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Levin JB, Moore DJ, Depp C, Montoya JL, Briggs F, Rahman M, Stange KC, Einstadter D, Weise C, Conroy C, Yala J, Radatz E, Sajatovic M. Using mHealth to improve adherence and reduce blood pressure in individuals with hypertension and bipolar disorder (iTAB-CV): study protocol for a 2-stage randomized clinical trial. Trials. 2022 Jun 29;23(1):539. doi: 10.1186/s13063-022-06449-9.

  PMID: 35768875 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Medication Adherence; Hypertension; Depressive Disorder, Major

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases; Depressive Disorder

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Jennifer Levin, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: December 19, 2020
• Study Start: March 15, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (1)