Health TrialsbyHealthPanel

Self-Management of Blood Pressure in Resistant Hypertension

ConditionResistant Hypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaichung Veterans General Hospital

About this trial

The trial is a 12-month randomized, parallel-group study comparing three arms: (1) HBP self-management with AI chatbot support, (2) HBP self-management without AI chatbot support, and (3) usual care. The primary objective is to evaluate differences in blood pressure changes and medication compliance between groups at 6 and 12 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age

receiving ≥3 antihypertensive medications of different classes, including a diuretic, and baseline BP >130/80 mmHg; or receiving ≥ 4 medications regardless of BP

Disqualifiers

unable to conduct self-monitor BP because of cognitive dysfunction

poor adherence to medication

poor digital capabilities

pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI chatbot support

    Behavioral

    Integrating the practice of self-monitoring of HBP with the use of AI chatbot responses. This arm includes reminders for patients to monitor their BP and take antihypertensive medications, and involves tracking BP readings over time and offering feedback. Moreover, this arm offers physician-endorsed guidance on modifying the dosage of antihypertensive medication and implementing lifestyle adjustments. It offers education on hypertension and the potential side effects of medication, as well as assistance with medication refills and scheduling appointments.

  • telemonitoring and case management

    Behavioral

    Combining self-monitoring of HBP with telemonitoring and case management. This arm includes reminders for patients to monitor their BP and take antihypertensive medications, and involves tracking BP readings over time and offering feedback. Moreover, this arm offers physician-endorsed guidance on modifying the dosage of antihypertensive medication and implementing lifestyle adjustments. It offers education on hypertension and the potential side effects of medication, as well as assistance with medication refills and scheduling appointments.

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: HBP self-management with AI chatbot supportExperimental treatment 1 intervention
Group B: HBP self-management without AI chatbot supportExperimental treatment 1 intervention
Group C: HBP-guided usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in HBP (systolic BP and diastolic BP) between baseline and each follow-up visit.

Primary endpoint

Time frame
6 and 12 months

Secondary outcomes

1

Office blood pressure endpoint

Difference between intervention and control groups in change in office blood pressure (OBP; systolic BP and diastolic BP) between baseline and each follow-up visit.

Time frame
6 and 12 months
2

Antihypertensive drug compliance endpoint

Difference between intervention and control groups in compliance to antihypertensive drugs during follow-up period, measured by pill count method.

Time frame
6 and 12 months

Other outcomes

Sponsors and contacts

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

Taichung Veterans General Hospital

Lead sponsor

Source ClinicalTrials.gov

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