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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Case Western Reserve University
RECRUITING
Cleveland
Contact Information
Primary
Jennifer Levin, PhD
jennifer.levin@case.edu
216-844-5057
Time Frame
Start Date: 2021-03-15
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 175
Treatments
Experimental: iTAB-CV + Self Monitoring
Receives iTAB-CV intervention plus self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating
Active_comparator: Self Monitoring
Receives self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating
Experimental: iTAB-CV + Self Monitoring - High Intensity Booster
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.
Experimental: iTAB-CV + Self Monitoring - Low Intensity Booster
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of California, San Diego, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Case Western Reserve University

This content was sourced from clinicaltrials.gov