Clinical trial NCT04675593: Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Mood Disorders
Official title: Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Mood Disorders.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Non-Adherence, Medication
Hypertension
Major Depressive Disorder
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-12-19
Enrollment: 175
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The proposed 5-year project uses a 2-stage randomized controlled trial (RCT) design to evaluate a brief, practical adherence intervention (iTAB-CV) delivered via interactive text messaging+ Self-Monitoring (SM) compared to SM alone. 200 individuals with mood disorder and HTN who are nonadherent with HTN medicine will be enrolled from mental health and primary care settings and the community. The underlying premise is that improving adherence to antihypertensives in BD and MDD is likely to be an efficient path to improving health outcomes in a vulnerable population. Findings on the relationship between habit strength, medication attitudes, mood, and adherence in this project will be generalizable to other populations.

The entire observation duration will be 11 months. In stage 1, after consenting and passing screen, participants will receive an automated device (eCAP) to track their use of antihypertensive medication. Participants will use the eCAP for 1 month until completing their baseline assessment. At that time, they will be randomized to either Arm 1 (iTAB-CV + self-monitoring) or Arm 2 (self-monitoring alone). Both interventions will be provided for 2 months with an interim phone/video assessment for adherence. At the end of this 2 month stage, participants will be seen for either a virtual or in-person assessment.

In stage 2, following the 3-month assessment, those in iTAB-CV will be re-randomized to receive either a high intensity (starts off with 1 reminder per day and tapers down to 1 reminder per week over the course of 2 months) or low intensity (1 reminder per week) booster + self-monitoring compared to self-monitoring alone. Adherence will be assessed by phone/video at 4 months as an interim measurement and a virtual or in-person assessment will occur at 5 months. In stage 3, investigators will follow participants for another 6 months without intervention with 1 interim phone/video assessment and a final virtual or in-person assessment at 11 months.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in the Tablet Routine Questionnaire (TRQ)
timeFrame: Baseline and Month 4
measure: Change in systolic blood pressure (SBP)
timeFrame: Baseline and Month 4
measure: Change in Adherence based on the Electronic Monitoring Device (eCAP)
timeFrame: Baseline and Month 4
Secondary outcomes:
measure: Change in Montgomery Asberg Rating Scale (MADRS) score
timeFrame: Month 4 and Month 6
measure: Change in engagement with iTAB intervention
timeFrame: Month 4 and Month 6
measure: Change in Beliefs About Medicines Questionnaire (BMQ) score
timeFrame: Month 4 and Month 6
measure: Change in Attitude towards Medication Questionnaire (AMSQ) score
timeFrame: Month 4 and Month 6
measure: Change in Self-efficacy for Medication Taking Behavior (MASES-R)
timeFrame: Month 4 and Month 6
measure: Change in Self-Report Habit Index (SRHI)
timeFrame: Month 9 and Month 12
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Jennifer Levin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.