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| Name | Class |
|---|---|
| University Hospitals Cleveland Medical Center | OTHER |
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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: OPTIMA-BP Implementation | Experimental | Participants randomized to OPTIMA-BP intervention for 6 months then observed for a 6 month follow up period |
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| Waitlist: OPTIMA-BP implementation | No Intervention | Participants randomized to waitlist for 6 months, then offered the OPTIMA-BP intervention for 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPTIMA-BP Intervention | Behavioral | Participants will continue their regular medical care, supplemented by the OPTIMA-BP intervention:
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Still, PHD | Contact | 216-368-6338 | carolyn.still@case.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carolyn Still, PhD | Case Western Reserve University, School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Recruiting | Cleveland | Ohio | 44143 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized controlled trial (RCT)
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Measured serum cholesterol (mg/dL); high-density lipoprotein (mg/dL); low density lipoprotein (mg/dL) and cholesterol (mg/dL)
| Baseline - 6 months |