ACTIVE_NOT_RECRUITING

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

Conditions

Bipolar Disorder Non-Adherence, Medication Hypertension Major Depressive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-03-15

Study Completion:2026-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04675593

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Jennifer Levin, PhD

PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Study Locations (Sites)

Case Western Reserve University

Cleveland, Ohio, 44106

United States

Collaborators and Investigators

Sponsor: Case Western Reserve University

Jennifer Levin, PhD, PRINCIPAL_INVESTIGATOR, Case Western Reserve University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-15

Study Completion Date2026-06-01

Study Record Updates

Study Start Date2021-03-15

Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

Bipolar Disorder
Non-Adherence, Medication
Hypertension
Major Depressive Disorder