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

OPtimizing Technology to Improve Medication Adherence and Blood Pressure Control

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Hypertension; Technology; Self-Management
• Intervention / Treatment: Behavioral: OPTIMA-BP Intervention

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

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolyn Still, PhD; Phone Number: 216-368-6338; Email: carolyn.still@case.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44143
      • Recruiting
      • Case Western Reserve University
      • Contact: Carolyn Still; Phone Number: 216-368-6338; Email: cwh11@case.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: OPTIMA-BP Implementation; Participants randomized to OPTIMA-BP intervention for 6 months then observed for a 6 month follow up period	Behavioral: OPTIMA-BP Intervention; Participants will continue their regular medical care, supplemented by the OPTIMA-BP intervention: Six weekly web-based education sessions on hypertension management.; Access to Medisafe, a medication management application (app) with a personalized medication adherence support (SMS reminder messages, adherence feedback, etc.) for 6 months.; 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.; Nurse Counseling Session with a research nurse for informal counseling, social support, and follow-up sessions regarding progress.; 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.
No Intervention: Waitlist: OPTIMA-BP implementation; Participants randomized to waitlist for 6 months, then offered the OPTIMA-BP intervention for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline - 6 months
Biological risk markers	Measured serum cholesterol (mg/dL); high-density lipoprotein (mg/dL); low density lipoprotein (mg/dL) and cholesterol (mg/dL)	Baseline - 6 months

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Carolyn Still, PhD, Case Western Reserve University, School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; Self-Management; Home Blood Pressure Monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 1R01NR019585-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No