HypertensionNCT05293756
OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP)
A study testing OPTIMA-BP Intervention in people with Hypertension and Self-Management, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hypertension, Self-Management, Technology
- What is being tested?
- OPTIMA-BP Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2021to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as African American
- 50 years of age or older
- Diagnosed with hypertension, with a systolic blood pressure≥ 130 mmHg but less than 170 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
Who cannot join
- Unable to give informed consent or judged to have impaired cognitive ability or severe memory
- Currently using a medication management application (app)
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44143
Carolyn Still, 216-368-6338, cwh11@case.edu
Mahbooh Rahman, MD, 216-844-3798
About this study
Official title: OPtimizing Technology to Improve Medication Adherence and Blood Pressure Control
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.
Read the 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:
- 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
- Conditions
- Hypertension, Self-Management, Technology, Quality of Life
- Being tested
- OPTIMA-BP Intervention
- Keywords
- Hypertension, Self-Management, Home Blood Pressure Monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMA-BP InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: OPTIMA-BP Implementation | Experimental | Participants randomized to OPTIMA-BP intervention for 6 months then observed for a 6 month follow up period Receives: Behavioral: OPTIMA-BP Intervention |
| Waitlist: OPTIMA-BP implementation | No intervention | Participants randomized to waitlist for 6 months, then offered the OPTIMA-BP intervention for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Baseline - 6 months
Secondary outcomes (2)
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
Measured: Baseline - 6 months
Biological risk markers
Measured serum cholesterol (mg/dL); high-density lipoprotein (mg/dL); low density lipoprotein (mg/dL) and cholesterol (mg/dL)
Measured: Baseline - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start14 Feb 2021
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (RCT)
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Responsible party
- Principal investigator, Carolyn Still, Case Western Reserve University
- Investigators
- Carolyn Still, PhD, Principal investigator, Case Western Reserve University, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293756
- Sponsor's protocol ID
- 1R01NR019585-01A1
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2022
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimizing Technology to Improve Medication Adherence and Blood Pressure Control
- ClinicalTrials.gov ID
- NCT05293756
- Acronym / sponsor ID
- 1R01NR019585-01A1
- Conditions
- Hypertension, Self-Management, Technology, Quality of Life
- Keywords
- Hypertension, Self-Management, Home Blood Pressure Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Study start
- 14 Feb 2021 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Intervention: OPTIMA-BP Implementation | Experimental | Behavioral: OPTIMA-BP InterventionParticipants randomized to OPTIMA-BP intervention for 6 months then observed for a 6 month follow up period |
| Waitlist: OPTIMA-BP implementation | No intervention | –Participants randomized to waitlist for 6 months, then offered the OPTIMA-BP intervention for 6 months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identify as African American
- 50 years of age or older
- Diagnosed with hypertension, with a systolic blood pressure≥ 130 mmHg but less than 170 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
Key exclusion criteria (4 listed)
- Unable to give informed consent or judged to have impaired cognitive ability or severe memory
- Currently using a medication management application (app)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTIMA-BP InterventionParticipants 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. | Behavioural | Intervention: OPTIMA-BP Implementation |
Primary outcome
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
2 secondary outcomes
Controlled BP (<130/80 mmHg)
Time frame: Baseline - 6 months
Biological risk markers
Time frame: Baseline - 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carolyn Still, PhD principal investigator
Case Western Reserve University, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIMA-BP Intervention in people with Hypertension and Self-Management, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Still, PHD (216-368-6338, carolyn.still@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Control (time frame: Baseline - 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.