Hypertension, Rheumatoid Arthritis
Conditions
Brief 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. 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.
Interventions
BEHAVIORALBlood pressure intervention arm
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.
Sponsors
Duke University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old or older * Uncontrolled hypertension * History of rheumatoid arthritis * Receive both primary care and rheumatology care from Duke Health System
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention feasibility as measured by participant accrual rates | 6 months | Rate at which participants are able to be successfully recruited |
| Intervention feasibility as measured by participant retention | 6 months | Percentage of participants who successfully complete the study |
| Intervention feasibility as measured by adherence to blood pressure monitoring | 6 months | Percentage of expected blood pressures reported by participants |
| Intervention feasibility as measured by adherence to survey reporting | 6 months | Percentage of expected surveys completed by participants |
| Intervention feasibility as measured by sample characteristics | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant blood pressure values | 6 months | Systolic and diastolic blood pressures taken at least three times per week and reported to the study team every 2 weeks for 6 months |
| Participant rheumatoid arthritis disease activity | 6 months | Rheumatoid arthritis disease activity self-reported by participants using the RAPID3 score every 2 weeks for 6 months |
| Participant medication use | 6 months | Medication use for hypertension and rheumatoid arthritis reported by participants every 2 weeks for 6 months |
| Anti-hypertensive medication adherence | 6 months | Participant self-reported adherence percentage to anti-hypertensive medications collected every 2 weeks for 6 months |
| Perceived barriers to hypertension self-management | 6 months | Participant self-reported barriers to hypertension self-management collected every 2 weeks for 6 months |
| Provider engagement as measured by response to study team messages | 6 months | Frequency and type of provider responses to study team messages |
| Provider engagement as measured by interactions with participants | 6 months | Frequency and type of provider interactions with participants after receiving a study team message |
| Care coordination | 6 months | Activation of care team members |
| Number of participants with a change in medical therapy | 6 months | Changes in anti-hypertensive or RA therapies |
Countries
United States
Contacts
CONTACTIsaac Smith, MD
Outcome results
None listed