Health TrialsbyHealthPanel

Virtual Lifestyle Medicine Group Visits for High Blood Pressure

ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lifestyle Medicine Virtual group

    Behavioral

    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 each 2 week block.

  • Usual Care Group

    Behavioral

    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.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Lifestyle Medicine Virtual Group Visit Program plus usual medical careExperimental treatment 2 interventions
Group B: Usual medical care onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in diastolic blood pressure readings

Time frame
2-4 weeks after randomization,6 months after randomization
2

Change in systolic blood pressure readings

Time frame
2-4 weeks after randomization,6 months after randomization

Secondary outcomes

1

Percentage of eligible participants who agree to participate

Time frame
end of study (6 months after randomization)
2

Number of primary care physicians (PCPs) whose patients are included in the program

Time frame
end of study (6 months after randomization)
3

Median number of sessions attended by each participant

Time frame
end of study (6 months after randomization)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: