HypertensionNCT05760898
Improving Hypertension Control in Rheumatoid Arthritis
A study testing Blood pressure intervention arm in people with Hypertension and Rheumatoid Arthritis, run by Duke University at 1 site in United States.
Trial summary
Rheumatoid arthritis (RA) is a autoimmune disease associated with an increased risk of developing coronary artery disease (CAD) and premature death,. Traditional CAD risk factors like hypertension (HTN) are both very common and poorly controlled among RA patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Rheumatoid Arthritis
- What is being tested?
- Blood pressure intervention arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2026to 31 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Uncontrolled hypertension
- History of rheumatoid arthritis
- Receive both primary care and rheumatology care from Duke Health System
Who cannot join
- Age less than 18 years old
- Healthy volunteers without rheumatoid arthritis and hypertension
- Do not receive both primary care and rheumatology care from Duke Health System
- Cognitive impairment with lack the capacity to consent to study participation
- Pregnant women
- Prisoners
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
Duke Health System
Durham, North Carolina, 27710
Edna Scarlett, 919-684-6150, edna.scarlett@duke.edu
Isaac Smith, MD, 919-613-2243, isaac.smith063@duke.edu
About this study
Official title: Improving Hypertension Control for Patients With Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a autoimmune disease associated with an increased risk of developing coronary artery disease (CAD) and premature death,. Traditional CAD risk factors like hypertension (HTN) are both very common and poorly controlled among RA patients. Patients with RA face significant challenges in controlling HTN. The goal of this project is to identify barriers to HTN care in patients with RA to reduce CAD events.
- Conditions
- Hypertension, Rheumatoid Arthritis
- Being tested
- Blood pressure intervention arm
- Medical subject headings
- Hypertension, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure intervention armBehavioural
The intervention will focus on empowering patients to actively participate in their HTN care, facilitating patient-provider communication, and creating a cohesive care team to close the coordination loop for HTN management. This pilot intervention will help achieve these goals by providing participants with home blood pressure monitors and teaching, improving patient-provider communication regarding blood pressure and RA management, and initiating care coordination between rheumatology and primary care providers.
| Study group | Role | What they receive |
|---|---|---|
| Blood pressure intervention arm | Experimental | The investigators will recruit 25 RA patients with HTN for the study. Participants will be provided with a home blood pressure monitor, teaching from nursing staff regarding the correct use of the monitor, and a guide to help interpret normal and elevated blood pressure values. Participants will be instructed to obtain and record blood pressure values at least three times per week over the course of 3 months. Every 2 weeks, these results will be sent to the study team, and participants will complete a brief survey regarding other factors that may influence blood pressure control, including RA disease activity (RAPID3 score), pain, current use of acute RA therapies, anti-hypertensive medication use, anti-hypertensive medication adherence, and current perceived barriers to HTN self-management. Receives: Behavioral: Blood pressure intervention arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention feasibility as measured by participant accrual rates
Rate at which participants are able to be successfully recruited
Measured: 6 months
Intervention feasibility as measured by participant retention
Percentage of participants who successfully complete the study
Measured: 6 months
Intervention feasibility as measured by adherence to blood pressure monitoring
Percentage of expected blood pressures reported by participants
Measured: 6 months
Intervention feasibility as measured by adherence to survey reporting
Percentage of expected surveys completed by participants
Measured: 6 months
Intervention feasibility as measured by sample characteristics
Description of sociodemographic characteristics of population, rheumatoid arthritis characteristics (eg, duration, medications, severity), and hypertension characteristics (eg, duration, medications, severity)
Measured: 6 months
Intervention feasibility as measured by use of resources
Cost of participant recruitment, education, blood pressure monitors, participant compensation, research coordinator time and cost needed to collect data, and statistical analysis
Measured: 6 months
Intervention feasibility as measured by sustainability of data collection procedures
Financial and time commitments required to successfully collect participant surveys, blood pressure monitoring results, send information to providers, and monitor provider responses
Measured: 6 months
Intervention acceptability as measured by qualitative interviews
Qualitative interviews will be performed at the end of the pilot intervention with all study participants to assess the acceptability of the intervention. Rheumatology and primary care providers caring for study participants will also be invited to comment on the acceptability of the intervention.
Measured: 6 months
Perceived appropriateness of the intervention to address the health care disparity in HTN (hypertension) control for Black RA patients as measured by qualitative interviews
Qualitative interviews will be performed at the end of the pilot intervention with all study participants to assess the perceived appropriateness of the intervention to address the health care disparity in HTN control for Black RA patients. Rheumatology and primary care providers caring for study participants will also be invited to comment on the appropriateness of the intervention.
Measured: 6 months
Barriers to and enablers of participating in the intervention as measured by qualitative interviews
Qualitative interviews will be performed at the end of the pilot intervention with all study participants to assess barriers to and enablers of participating in the intervention.
Measured: 6 months
Secondary outcomes (9)
Participant blood pressure values
Systolic and diastolic blood pressures taken at least three times per week and reported to the study team every 2 weeks for 6 months
Measured: 6 months
Participant rheumatoid arthritis disease activity
Rheumatoid arthritis disease activity self-reported by participants using the RAPID3 score every 2 weeks for 6 months
Measured: 6 months
Participant medication use
Medication use for hypertension and rheumatoid arthritis reported by participants every 2 weeks for 6 months
Measured: 6 months
Anti-hypertensive medication adherence
Participant self-reported adherence percentage to anti-hypertensive medications collected every 2 weeks for 6 months
Measured: 6 months
Perceived barriers to hypertension self-management
Participant self-reported barriers to hypertension self-management collected every 2 weeks for 6 months
Measured: 6 months
Provider engagement as measured by response to study team messages
Frequency and type of provider responses to study team messages
Measured: 6 months
Provider engagement as measured by interactions with participants
Frequency and type of provider interactions with participants after receiving a study team message
Measured: 6 months
Care coordination
Activation of care team members
Measured: 6 months
Number of participants with a change in medical therapy
Changes in anti-hypertensive or RA therapies
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start16 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760898
- Sponsor's protocol ID
- PRO00112307
- Other IDs
- 3U54MD012530-05S2
- Status last verified
- Aug 2025
- First submitted
- 9 Feb 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Hypertension Control for Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05760898
- Acronym / sponsor ID
- PRO00112307
- Conditions
- Hypertension, Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Mar 2023 (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.
Rheumatoid arthritis (RA) is a autoimmune disease associated with an increased risk of developing coronary artery disease (CAD) and premature death,. Traditional CAD risk factors like hypertension (HTN) are both very common and poorly controlled among RA patients. Patients with RA face significant challenges in controlling HTN. The goal of this project is to identify barriers to HTN care in patients with RA to reduce CAD events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood pressure intervention arm | Experimental | Behavioral: Blood pressure intervention armThe investigators will recruit 25 RA patients with HTN for the study. Participants will be provided with a home blood pressure monitor, teaching from nursing staff regarding the correct use of the monitor, and a guide to help interpret normal and elevated blood pressure values. Participants will be instructed to obtain and record blood pressure values at least three times per week over the course of 3 months. Every 2 weeks, these results will be sent to the study team, and participants will complete a brief survey regarding other factors that may influence blood pressure control, including RA disease activity (RAPID3 score), pain, current use of acute RA therapies, anti-hypertensive medication use, anti-hypertensive medication adherence, and current perceived barriers to HTN self-management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older
- Uncontrolled hypertension
- History of rheumatoid arthritis
- Receive both primary care and rheumatology care from Duke Health System
Key exclusion criteria (6 listed)
- Age less than 18 years old
- Healthy volunteers without rheumatoid arthritis and hypertension
- Do not receive both primary care and rheumatology care from Duke Health System
- Cognitive impairment with lack the capacity to consent to study participation
- Pregnant women
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 |
|---|---|---|
| Blood pressure intervention armThe intervention will focus on empowering patients to actively participate in their HTN care, facilitating patient-provider communication, and creating a cohesive care team to close the coordination loop for HTN management. This pilot intervention will help achieve these goals by providing participants with home blood pressure monitors and teaching, improving patient-provider communication regarding blood pressure and RA management, and initiating care coordination between rheumatology and primary care providers. | Behavioural | Blood pressure intervention arm |
Primary outcome
Intervention feasibility as measured by participant accrual rates
Time frame: 6 months
Rate at which participants are able to be successfully recruited
Intervention feasibility as measured by participant retention
Time frame: 6 months
Percentage of participants who successfully complete the study
Intervention feasibility as measured by adherence to blood pressure monitoring
Time frame: 6 months
Percentage of expected blood pressures reported by participants
Intervention feasibility as measured by adherence to survey reporting
Time frame: 6 months
Percentage of expected surveys completed by participants
Intervention feasibility as measured by sample characteristics
Time frame: 6 months
Description of sociodemographic characteristics of population, rheumatoid arthritis characteristics (eg, duration, medications, severity), and hypertension characteristics (eg, duration, medications, severity)
Intervention feasibility as measured by use of resources
Time frame: 6 months
Cost of participant recruitment, education, blood pressure monitors, participant compensation, research coordinator time and cost needed to collect data, and statistical analysis
Intervention feasibility as measured by sustainability of data collection procedures
Time frame: 6 months
Financial and time commitments required to successfully collect participant surveys, blood pressure monitoring results, send information to providers, and monitor provider responses
Intervention acceptability as measured by qualitative interviews
Time frame: 6 months
Qualitative interviews will be performed at the end of the pilot intervention with all study participants to assess the acceptability of the intervention. Rheumatology and primary care providers caring for study participants will also be invited to comment on the acceptability of the intervention.
Perceived appropriateness of the intervention to address the health care disparity in HTN (hypertension) control for Black RA patients as measured by qualitative interviews
Time frame: 6 months
Qualitative interviews will be performed at the end of the pilot intervention with all study participants to assess the perceived appropriateness of the intervention to address the health care disparity in HTN control for Black RA patients. Rheumatology and primary care providers caring for study participants will also be invited to comment on the appropriateness of the intervention.
Barriers to and enablers of participating in the intervention as measured by qualitative interviews
Time frame: 6 months
Qualitative interviews will be performed at the end of the pilot intervention with all study participants to assess barriers to and enablers of participating in the intervention.
9 secondary outcomes
Participant blood pressure values
Time frame: 6 months
Participant rheumatoid arthritis disease activity
Time frame: 6 months
Participant medication use
Time frame: 6 months
Anti-hypertensive medication adherence
Time frame: 6 months
Perceived barriers to hypertension self-management
Time frame: 6 months
Provider engagement as measured by response to study team messages
Time frame: 6 months
Provider engagement as measured by interactions with participants
Time frame: 6 months
Care coordination
Time frame: 6 months
Number of participants with a change in medical therapy
Time frame: 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 6 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure intervention arm in people with Hypertension and Rheumatoid Arthritis, run by Duke 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 4 inclusion and 6 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 6 Feb 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 Isaac Smith, MD (919-613-2243, isaac.smith063@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention feasibility as measured by participant accrual rates (time frame: 6 months). The study lists 10 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 6 Feb 2026.