Clinical trial NCT05293756: OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP)
Official title: OPtimizing Technology to Improve Medication Adherence and Blood Pressure Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Self-Management
Technology
Quality of Life
Keywords: Hypertension
Self-Management
Home Blood Pressure Monitoring
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2022-03-24
Enrollment: 208
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (RCT)
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Blood Pressure Control
timeFrame: Baseline - 6 months
measure: Health Related Quality of Life (HRQOL)
timeFrame: Baseline - 6 months
Secondary outcomes:
measure: Controlled BP (<130/80 mmHg)
timeFrame: Baseline - 6 months
measure: Biological risk markers
timeFrame: Baseline - 6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University, School of Nursing
name: Carolyn Still, PhD
role: PRINCIPAL_INVESTIGATOR
References: