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

Primary Purpose

Hypertension, Self-Management, Technology

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OPTIMA-BP Intervention
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension focused on measuring Hypertension, Self-Management, Home Blood Pressure Monitoring

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Case Western Reserve UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention: OPTIMA-BP Implementation

Waitlist: OPTIMA-BP implementation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2022
Last Updated
April 12, 2023
Sponsor
Case Western Reserve University
Collaborators
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05293756
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2021 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Self-Management, Technology, Quality of Life
Keywords
Hypertension, Self-Management, Home Blood Pressure Monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial (RCT)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention: OPTIMA-BP Implementation
Arm Type
Experimental
Arm Description
Participants randomized to OPTIMA-BP intervention for 6 months then observed for a 6 month follow up period
Arm Title
Waitlist: OPTIMA-BP implementation
Arm Type
No Intervention
Arm Description
Participants randomized to waitlist for 6 months, then offered the OPTIMA-BP intervention for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
OPTIMA-BP Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Pressure Control
Description
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
Title
Health Related Quality of Life (HRQOL)
Description
Assess HRQOL using PROMIS Global Health-10. (Raw score range from 4-20, higher score represents better health
Time Frame
Baseline - 6 months
Secondary Outcome Measure Information:
Title
Controlled BP (<130/80 mmHg)
Description
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
Title
Biological risk markers
Description
Measured serum cholesterol (mg/dL); high-density lipoprotein (mg/dL); low density lipoprotein (mg/dL) and cholesterol (mg/dL)
Time Frame
Baseline - 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Self-identify as African American 50 years of age or older Diagnosed with hypertension, with a blood pressure≥ 130/80 mmHg) but less than 160/90 mmHg Prescribed at least two hypertensive, one of which is a diuretic/thiazide and or calcium channel blocker antihypertensive medication Own a smartphone with a data plan, the capability to download the Medisafe app, or view videos Able to read/understand English Exclusion Criteria: Unable to give informed consent or judged to have impaired cognitive ability or severe memory Currently using a medication management application (app) Screening visit-to-visit BP variability ≥ 10 mmHg 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolyn Still, PhD
Phone
216-368-6338
Email
carolyn.still@case.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Still, PhD
Organizational Affiliation
Case Western Reserve University, School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Still
Phone
216-368-6338
Email
cwh11@case.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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