Hypertension Management Using Remote Patient Monitoring

Hypertension Clinical Trial

Official title:

A Pilot Study of Hypertension Management Using Remote Patient Monitoring- Extended Follow Up Using Matched Cohort Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05562921
• Other study ID #: STU00213093-3
• Status: Completed
• Start date: November 18, 2018
• Est. completion date: February 14, 2023

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A longer-term follow-up of patients with remote patient monitoring ordered from the initial six pilot primary care clinics (from the prior study periods: Study 1 and Study 2) will be performed and compared to a cohort of patients without RPM orders, matched on clinical and demographic characteristics, from the same six pilot primary care clinics, to serve as contemporary controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1440
• Est. completion date: February 14, 2023
• Est. primary completion date: August 14, 2022
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria Cases Patients from any of 6 primary care sites that participated in remote monitoring pilots who had remote patient monitoring (RPM) ordered by a primary care clinician between November 18, 2018 and August 14, 2021

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Exclusion Criteria:

• Patients whose RPM ordered by non-primary care clinics

Matching cohort Inclusion

• Patients from the six pilot clinics AND

• Meet the matching criteria Exclusion

• Patients with any RPM order between between November 18, 2018 and August 14, 2021

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Controls-ususal care
Controls: patients who did not receive remote patient monitoring for blood pressure prescribed during routine care delivery, with multivariable matching to cases
• Cases-remote patient monitoring prescribed
Cases: patients prescribed remote patient monitoring for blood pressure during routing care delivery

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Omron Healthcare Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean SBP at most recent office visit	Mean SBP at most recent office visit	18 months
Other	Mean SBP at most recent office visit	Mean SBP at most recent office visit	15 months
Other	Mean SBP at most recent office visit	Mean SBP at most recent office visit	12 months
Other	Mean SBP on most recent measurement date (office or out of office)	Mean SBP on most recent measurement date (office or out of office)	18 months
Other	Mean SBP on most recent measurement date (office or out of office)	Mean SBP on most recent measurement date (office or out of office)	15 months
Other	Mean SBP on most recent measurement date (office or out of office)	Mean SBP on most recent measurement date (office or out of office)	12 months
Other	Ambulatory care utilization--office visits	Count of primary care office visits during time frame	18 months
Other	Ambulatory care utilization--telephone calls	Count of primary care telephone encounters during time frame	18 months
Other	Ambulatory care utilization--patient portal messages	Count of primary care patient portal encounters during time frame	18 months
Other	Proportion of patients with an increase in serum creatinine of =30%	Proportion of patients with an increase in serum creatinine of =30%	18 months
Primary	Controlling High Blood Pressure (NQF 0018)	Proportion of patients who satisfy the performance measure Controlling High Blood Pressure (NQF 0018), last BP done within 1 year and is less than 140/90 mm Hg	18 months
Primary	Controlling High Blood Pressure (NQF 0018)	Proportion of patients who satisfy the performance measure Controlling High Blood Pressure (NQF 0018), last BP done within 1 year and is less than 140/90 mm Hg	15 months
Primary	Controlling High Blood Pressure (NQF 0018)	Proportion of patients who satisfy the performance measure Controlling High Blood Pressure (NQF 0018), last BP done within 1 year and is less than 140/90 mm Hg	12 months
Secondary	Antihypertensive medication intensification	Count of antihypertensive medication drug classes added or increased during the time frame minus the number decreased or discontinued	18 months
Secondary	Antihypertensive medication intensification	Count of antihypertensive medication drug classes added or increased during the time frame minus the number decreased or discontinued	15 months
Secondary	Antihypertensive medication intensification	Count of antihypertensive medication drug classes added or increased during the time frame minus the number decreased or discontinued	12 months