Recruiting

OPTIMA-BP

Sponsor:

Case Western Reserve University

Code:

NCT05293756

Conditions

Hypertension

Self-Management

Technology

Quality of Life

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

OPTIMA-BP Intervention

Study Details

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

Study ID

NCT05293756

Start date

Feb 14, 2021

Status verified date

Mar, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Self-identify as African American
2. 50 years of age or older
3. Diagnosed with hypertension, with a systolic blood pressure≥ 130 mmHg but less than 170 mmHg
4. Prescribed at least two hypertensive, one of which is a diuretic/thiazide and or calcium channel blocker antihypertensive medication
5. Own a smartphone with a data plan, the capability to download the Medisafe app, or view videos
6. Able to read/understand English

Exclusion Criteria:

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

Study Design

Enrollment

208 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention: OPTIMA-BP Implementation

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

no intervention: Waitlist: OPTIMA-BP implementation

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

Interventions

OPTIMA-BP Intervention

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.

Primary outcome measure

  • Blood Pressure Control [ Time Frame: Baseline - 6 months ]
  • Health Related Quality of Life (HRQOL) [ Time Frame: Baseline - 6 months ]

Central Contacts and Locations

Central contacts

Locations

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44143

Contacts

Mahbooh Rahman, MD

216-844-3798

Principal Investigator:

Mahboob Rahman, MD

More Information

Sponsor

Case Western Reserve University

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Keywords

  • Hypertension
  • Self-Management
  • Home Blood Pressure Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-04-03.