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

NCT ID: NCT05293756

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-14
• Study Completion Date: 2026-05-31

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.

Detailed Description

OPTIMA-BP investigates the effectiveness of a technology-based intervention (TBI) for hypertension self-management and to improve blood pressure (BP) control.

The investigators aims to:

1. To test the effects of OPTIMA-BP over a 12-month period vs. a 6 month waitlist control (WL) on systolic BP and health-related quality of life (HRQOL) in African American older adults with HTN in a prospective, randomized control trial.

2. To test if the attitudinal/knowledge mechanisms of self-management (HTN knowledge, self-efficacy, perceived social support) and proximal behavioral target mechanisms (taking medications to reduce systolic BP, diet, exercise) mediate OPTIMA-BP vs. WL's impact on the primary and secondary outcomes (systolic BP, diastolic BP, HRQOL, serum lipids, and at least 62% of the sample with BP <130/80 mmHg) over a 12-month period.

The investigator also aims to:

3. Utilize qualitative evaluation to confirm self-management barriers and perceived strengths or limitations of the intervention, which will inform future refinements should these randomized controlled trial (RCT) findings be positive

Conditions

Hypertension; Self-Management; Technology; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention: OPTIMA-BP Implementation

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

Group Type: EXPERIMENTAL

OPTIMA-BP Intervention

Intervention Type: 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.

Waitlist: OPTIMA-BP implementation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Carolyn Still

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn Still, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University, School of Nursing

Locations

Case Western Reserve University

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carolyn Still, PhD

Role: CONTACT

carolyn.still@case.edu

216-368-6338

Facility Contacts

Carolyn Still

Role: primary

cwh11@case.edu

216-368-6338

Other Identifiers

1R01NR019585-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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