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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT05293756
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Feb 14, 2021
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
208 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Blood Pressure Control [ Time Frame: Baseline - 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Western Reserve UniversityClevelandOhio44143
Carolyn Still
[email protected]
216-368-6338
Mahbooh Rahman, MD
216-844-3798
Mahboob Rahman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Case Western Reserve University· Cleveland, OH

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