Clinical trial NCT05562921: Hypertension Management Using Remote Patient Monitoring
Official title: A Pilot Study of Hypertension Management Using Remote Patient Monitoring- Extended Follow Up Using Matched Cohort Design
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Omron Healthcare Co., Ltd.
First posted: 2022-10-03
Enrollment: 1440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case population includes patients with RPM for blood pressure ordered from the six pilot primary care clinics between November 18, 2018 and August 14, 2021, are 65 to 85 years old, and have Medicare insurance.

Control population are patients selected from the same practices using propensity score matching who were not prescribed RPM for blood pressure.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Controlling High Blood Pressure (NQF 0018)
timeFrame: 18 months
measure: Controlling High Blood Pressure (NQF 0018)
timeFrame: 15 months
measure: Controlling High Blood Pressure (NQF 0018)
timeFrame: 12 months
Secondary outcomes:
measure: Antihypertensive medication intensification
timeFrame: 18 months
measure: Antihypertensive medication intensification
timeFrame: 15 months
measure: Antihypertensive medication intensification
timeFrame: 12 months
Other outcomes:
measure: Mean SBP at most recent office visit
timeFrame: 18 months
measure: Mean SBP at most recent office visit
timeFrame: 15 months
measure: Mean SBP at most recent office visit
timeFrame: 12 months
measure: Mean SBP on most recent measurement date (office or out of office)
timeFrame: 18 months
measure: Mean SBP on most recent measurement date (office or out of office)
timeFrame: 15 months
measure: Mean SBP on most recent measurement date (office or out of office)
timeFrame: 12 months
measure: Ambulatory care utilization--office visits
timeFrame: 18 months
measure: Ambulatory care utilization--telephone calls
timeFrame: 18 months
measure: Ambulatory care utilization--patient portal messages
timeFrame: 18 months
measure: Proportion of patients with an increase in serum creatinine of ≥30%
timeFrame: 18 months
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stephen D Persell, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References: