Hypertension
Conditions
Keywords
high blood pressure, telemedicine, African-American
Brief summary
The purpose of study is to understand the different factors (patient, societal, provider, clinic, health system) relevant in recruitment and participation of patients in Team Based Equity Conscious Telemedicine Approach to Improve Hypertension clinical trial.
Detailed description
Black patients suffer disproportionate hypertension (HTN) burden with worse control, resulting in HTN-related mortality rates twice those observed in non-Hispanic White patients. Contextually informed care approach is urgently needed in Black patients for HTN management. This study will evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a Team Based Equity Conscious Telemedicine Approach to Improve Hypertension (TET-HTN) clinical trial. This study will also evaluate the feasibility of TET-HTN intervention in a randomized comparison with usual clinic-based hypertension care approach.
Interventions
OTHERFeasibility Interview
One audio-recorded interview with the participants lasting about 30-minutes
BEHAVIORALTeam Based Equity Conscious Telemedicine Hypertension Intervention
Will provide blood pressure monitor connected to a telehealth application. Patients will be asked to measure home blood pressure once daily. Will intensify medications as needed based on blood pressure measurement. Trained nurses or pharmacists will provide 4 self-management telephone calls (up to 30 minutes per call) to patients to address hypertension knowledge, medication adherence, healthy eating, physical activity, weight management, stress management, tobacco and alcohol use, and sleep apnea (with referrals if needed). Will support needs relevant in blood pressure control using locally available resources via community health worker and social workers.
BEHAVIORALUsual Care
Usual clinic based hypertension care using routinely available clinic services including community health worker/social worker. Clinicians can offer self-management support (e.g., dietician referral) or recommend a home blood pressure monitor. These activities mirror current primary care practice.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This study has two main objectives. First, to evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a TET-HTN clinical trial (Aim 1). Second objective is to evaluate the feasibility of TET-HTN intervention in a randomized comparison with usual clinic-based hypertension care approach (Aim 2).
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* African American or Black * Patients with last clinic systolic Blood Pressure \>140 mmHg or diastolic Blood Pressure \>90 mmHg or both
Exclusion criteria
* Unable to read or speak English * diminished ability to measure home BP (dementia, or psychosis) * acute health changes in past 3 months increasing chance of BP instability (hospitalization); * terminal illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Barriers / Facilitators for Recruitment | Day 1 | Evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a Team based Equity conscious Telemedicine (TET-HTN) clinical trial - will be reported as themes from thematic analysis of qualitative data |
| Feasibility of Telemedicine Approach - Proportion of Subjects | Month 6 | Evaluate the feasibility of Team Based Equity Conscious Telemedicine Hypertension intervention in a randomized comparison with usual clinic-based hypertension care. Feasibility will be measured using the proportion of patients screened, eligible, agree to participate and decline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure | Month 6 | Changes in Systolic and Diastolic Blood Pressure |
| Percentage of Medication adherence | Month 6 | Medication adherence using the Proportion of Days Covered |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Emergency Department and Urgent Care Visits | Month 6 | Number of clinic, urgent care and emergency department visits |
| Number of Subjects using Blood Pressure Monitors | Month 6 | Patient self-reported home BP monitor use |
Countries
United States
Outcome results
None listed