Virtual Lifestyle Medicine Group Visits for High Blood Pressure

Official title

A Scalable, Lifestyle Medicine Intervention for Hypertension Using Virtual Group Shared Medical Appointments

Overview

The purpose of this study is to learn whether virtual Lifestyle medicine shared medical appointments (LMSMAs) can help people better manage their blood pressure and improve their overall health.

Interventions

• Behavioral Lifestyle Medicine Virtual group
  Participants will be given a home BP monitor upon enrollment and the group will engage in twice monthly virtual shared medical appointments (vSMAs) for 4 visits. Prior to each visit, participants will be asked to complete home BP monitoring (twice in the morning and twice in the evening for 3 days before visit), with readings reviewed during visits and medications adjusted as clinically indicated. Participants will complete four sessions over an 8-week period, with one session type offered in ea
• Behavioral Usual Care Group
  Participants will be given a home BP monitor upon enrollment and will be instructed by phone and with an electronic health record (EHR) portal message on proper technique for home BP readings. Participants will continue to have follow-up visits with their PCP as clinically indicated.

Primary outcome measures

• Change in diastolic blood pressure readings [Time frame: 2-4 weeks after randomization,6 months after randomization]
• Change in systolic blood pressure readings [Time frame: 2-4 weeks after randomization,6 months after randomization]

Secondary outcome measures (5)

• Percentage of eligible participants who agree to participate [Time frame: end of study (6 months after randomization)]
• Number of primary care physicians (PCPs) whose patients are included in the program [Time frame: end of study (6 months after randomization)]
• Median number of sessions attended by each participant [Time frame: end of study (6 months after randomization)]
• Adherence as assessed by the number of of blood pressure (BP) readings submitted between each session [Time frame: end of study (6 months after randomization)]
• Adherence to home BP monitoring as assessed by the number of of home BP sessions submitted between each session [Time frame: end of study (6 months after randomization)]

Eligibility criteria

Inclusion criteria

• Current diagnosis of hypertension (ICD codes I10.0-I14.0 billed within the last 5 years Essential HTN, Essential HTN, Primary HTN)
• Currently receives care at a UTPhysicians; Last seen by a PCP at Victory location within the last 1 year.
• Able to participate in a virtual format
• Willingness to participate and engage in home blood pressure monitoring

Exclusion criteria

• Unstable cardiovascular disease (recent Myocardial Infarction (MI), unstable angina, decompensated HF)
• Advanced Chronic kidney disease (CKD) (eGFR < 30) without nephrology co-management
• Active cancer treatment
• Severe cognitive impairment (unable to engage)
• Uncontrolled psychiatric illness (e.g., active psychosis)
• Resistant hypertension (requiring> 3 medications at maximum doses)
• Unable to participate in English class format
• Unstable internet or lack of smartphone

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07698509 · HSC-MS-26-0577

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗