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
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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|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||208 participants|
|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|
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:
No Intervention: Waitlist: OPTIMA-BP implementation
Participants randomized to waitlist for 6 months, then offered the OPTIMA-BP intervention for 6 months.
- 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).
- 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
- 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
- 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)
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|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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
|Contact: Carolyn Still, PhDfirstname.lastname@example.org|
|United States, Ohio|
|Case Western Reserve University||Recruiting|
|Cleveland, Ohio, United States, 44143|
|Contact: Carolyn Still 216-368-6338 email@example.com|
|Principal Investigator:||Carolyn Still, PhD||Case Western Reserve University, School of Nursing|
|Responsible Party:||Carolyn Still, Assistant Professor, Case Western Reserve University|
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Home Blood Pressure Monitoring