OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP)

NCT05293756 | Recruiting DMC

• 1 other identifier: 1R01NR019585-01A1
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension (HTN) has a greater impact on African Americans (AA) than any other U.S. racial group. Uncontrolled blood pressure (BP) contributes to higher rates of disability, death, and health resource use among AA. HTN is the single most influential risk factor for cardiovascular disease (CVD), as well as a risk factor for the incidence of stroke, diabetes, chronic kidney disease, and dementia. Importantly, older adults account for 15% of the U.S. population, and two-thirds of older adults over age 60 have HTN, with higher rates observed in AA older adults. Strategies to support self-managing HTN and BP control are crucial as the older population is projected to age considerably and become more racially and ethnically diverse. Research has documented the negative effects on health and health outcomes of poorly controlled BP and is one of the most important modifiable CVD risk factors. Lower BP targets will require aggressive management and an increase in antihypertensive medications. Therefore, to achieve lower targets in this population, greater efforts, including patient-centered methods will be needed to support self-managing HTN, especially in terms of medication adherence. As we shifted into the digital age, the use of mHealth technologies (smart phones, applications, SMS or text messaging) has been a powerful approach and mechanism for the treatment and management of chronic diseases. However, behavioral interventions that incorporate technology do not reach minorities or disadvantaged AA older adults with HTN. OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP) will leverage existing knowledge of effective technology-based components for HTN self-management to support and improve BP control using unique aspects of mHealth platforms in AA older adults. Findings from this study, if confirmed, will improve BP control and support self-managing HTN, as well as has the potential to close the health disparity gap between AA and non-AA older adults with HTN.

Conditions

Hypertension; Self-Management; Technology; Quality of Life

Keywords

Hypertension; Self-Management; Home Blood Pressure Monitoring

Outcome Measures

Primary Outcomes (2)

• Blood Pressure Control

  Systolic BP \< 130 mmHg or Diastolic BP \< 80 mmHg, represents improved blood pressure control, measured digitally using a standard automatic BP device (Omron HEM-907 XL).

  Baseline - 6 months

• Health Related Quality of Life (HRQOL)

  Assess HRQOL using PROMIS Global Health-10. (Raw score range from 4-20, higher score represents better health

  Baseline - 6 months

Secondary Outcomes (2)

• Controlled BP (<130/80 mmHg)

  Baseline - 6 months

• Biological risk markers

  Baseline - 6 months

Study Arms (2)

Intervention: OPTIMA-BP Implementation

EXPERIMENTAL

Participants randomized to OPTIMA-BP intervention for 6 months then observed for a 6 month follow up period

Behavioral: OPTIMA-BP Intervention

Waitlist: OPTIMA-BP implementation

NO INTERVENTION

Participants randomized to waitlist for 6 months, then offered the OPTIMA-BP intervention for 6 months.

Interventions

OPTIMA-BP Intervention BEHAVIORAL

Participants will continue their regular medical care, supplemented by the OPTIMA-BP intervention: 1. Six weekly web-based education sessions on hypertension management. 2. Access to Medisafe, a medication management application (app) with a personalized medication adherence support (SMS reminder messages, adherence feedback, etc.) for 6 months. 3. Home Blood Pressure Monitoring (Omron series 10 home BP monitor). Participants will be asked to monitor and record their BP, 2x daily (AM and PM), twice a week, in a tracking log for 6 months. 4. Nurse Counseling Session with a research nurse for informal counseling, social support, and follow-up sessions regarding progress. 5. Optimizing HTN Treatment with 208 AA participants, in conjunction with their physician to maintain treatment goal BP: \< 130/80 mmHg. based on current HTN guidelines and study recommendations including chlorthalidone 12.5-25 mg/day or amlodipine 5-10 mg/day or as chosen by their doctor.

Intervention: OPTIMA-BP Implementation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identify as African American
• years of age or older
• Diagnosed with hypertension, with a systolic blood pressure≥ 130 mmHg but less than 170 mmHg
• Prescribed at least two hypertensive, one of which is a diuretic/thiazide and or calcium channel blocker antihypertensive medication
• Own a smartphone with a data plan, the capability to download the Medisafe app, or view videos
• Able to read/understand English

You may not qualify if:

• Unable to give informed consent or judged to have impaired cognitive ability or severe memory
• Currently using a medication management application (app)
• Experienced a major CVD event or procedure (e.g., myocardial infarction, stroke, heart surgery) within the past year
• Patients with a diagnosis of chronic kidney disease (defined as estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2) and/or receiving dialysis.

Sponsors & Collaborators

• Case Western Reserve University: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44143, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Carolyn Still, PhD

  Case Western Reserve University, School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Still, PhD

CONTACT

216-368-6338; carolyn.still@case.edu

Study Design

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

Model Details: Randomized controlled trial (RCT)

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 24, 2022
• Study Start: February 14, 2021
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)