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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorCase Western Reserve University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Self-identify as African American

50 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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: Intervention: OPTIMA-BP ImplementationExperimental treatment 1 intervention
Group B: Waitlist: OPTIMA-BP implementationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline - 6 months
2

Health Related Quality of Life (HRQOL)

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

Time frame
Baseline - 6 months

Secondary outcomes

1

Controlled BP (<130/80 mmHg)

Assess the Change in systolic BP/diastolic BP. Goal of 62% of Study sample with SBP \<130 mmHg. Systolic BP \<130 mmHg represents better BP control

Time frame
Baseline - 6 months
2

Biological risk markers

Measured serum cholesterol (mg/dL); high-density lipoprotein (mg/dL); low density lipoprotein (mg/dL) and cholesterol (mg/dL)

Time frame
Baseline - 6 months

Other outcomes

Sponsors and contacts

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Case Western Reserve University

Lead sponsor

University Hospitals Cleveland Medical Center

Collaborator