Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524180
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Can TElemedicine System Replace Doctor Consultations to Achieve Non-inferior Blood Pressure in Patients with Controlled Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Can TElemedicine System Replace Doctor Consultations to Achieve Non-inferior Blood Pressure in Patients with Controlled Hypertension TEACH a Randomised Controlled Trial and Cost-minimization Analysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEACH
Brief Summary:
The goal of this clinical trial is to evaluate whether patients assigned to the telemedicine HealthCap group demonstrate non-inferior blood pressure BP control compared to patients in the usual care group at 12 months The main question it aims to answer is
Do participants in telemedicine group have non-inferior daytime ambulatory blood pressure readings at 12-month compared to usual care group
Do participants in telemedicine group have better HT treatment higher self-efficacy reduced number of visits to primary care clinics and similar health care utilisation other than GOPCs compared to usual care group
Participant in telemedicine group will
Receive reminders to measure 7-day home blood pressure before their index consultation
Get their drug refilled automatically as well as have consultations deferred 16-18 weeks later if their blood pressure is under optimal control
Have consultations as scheduled if their BP is suboptimal or any of the safety questions screen positive
Participants in control group will
Have consultation with physicians every 16-18 weeks
Do participants in telemedicine group have non-inferior daytime ambulatory blood pressure readings at 12-month compared to usual care group
Do participants in telemedicine group have better HT treatment higher self-efficacy reduced number of visits to primary care clinics and similar health care utilisation other than GOPCs compared to usual care group
Participant in telemedicine group will
Receive reminders to measure 7-day home blood pressure before their index consultation
Get their drug refilled automatically as well as have consultations deferred 16-18 weeks later if their blood pressure is under optimal control
Have consultations as scheduled if their BP is suboptimal or any of the safety questions screen positive
Participants in control group will
Have consultation with physicians every 16-18 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None