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

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ClinicalTrials.gov Identifier: NCT05293756
Recruitment Status : Recruiting
First Posted : March 24, 2022
Last Update Posted : March 24, 2022
Sponsor:
Collaborator:
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Carolyn Still, Case Western Reserve University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypertension Self-Management Technology Quality of Life Behavioral: OPTIMA-BP Intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial (RCT)
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: OPtimizing Technology to Improve Medication Adherence and Blood Pressure Control
Actual Study Start Date : February 14, 2021
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : May 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:

  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.
No Intervention: Waitlist: OPTIMA-BP implementation
Participants randomized to waitlist for 6 months, then offered the OPTIMA-BP intervention for 6 months.


Outcome Measures
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Primary Outcome Measures :
  1. Blood Pressure Control [ Time Frame: Baseline - 6 months ]
    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).

  2. Health Related Quality of Life (HRQOL) [ Time Frame: Baseline - 6 months ]
    Assess HRQOL using PROMIS Global Health-10. (Raw score range from 4-20, higher score represents better health


Secondary Outcome Measures :
  1. Controlled BP (<130/80 mmHg) [ Time Frame: Baseline - 6 months ]
    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

  2. Biological risk markers [ Time Frame: Baseline - 6 months ]
    Measured serum cholesterol (mg/dL); high-density lipoprotein (mg/dL); low density lipoprotein (mg/dL) and cholesterol (mg/dL)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Self-identify as African American
  2. 50 years of age or older
  3. Diagnosed with hypertension, with a blood pressure≥ 130/80 mmHg) but less than 160/90 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. Screening visit-to-visit BP variability ≥ 10 mmHg
  4. Experienced a major CVD event or procedure (e.g., myocardial infarction, stroke, heart surgery) within the past year
  5. Patients with a diagnosis of chronic kidney disease (defined as estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2) and/or receiving dialysis.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05293756


Contacts
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Contact: Carolyn Still, PhD 216-368-6338 carolyn.still@case.edu

Locations
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United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44143
Contact: Carolyn Still    216-368-6338    cwh11@case.edu   
Sponsors and Collaborators
Case Western Reserve University
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Carolyn Still, PhD Case Western Reserve University, School of Nursing
More Information
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Responsible Party: Carolyn Still, Assistant Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT05293756    
Other Study ID Numbers: 1R01NR019585-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2022    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolyn Still, Case Western Reserve University:
Hypertension
Self-Management
Home Blood Pressure Monitoring
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases