Hypertension Management Using Remote Patient Monitoring

• Sponsor: Northwestern University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05562921
• Collaborator: Omron Healthcare Co., Ltd. (Industry)
• Enrollment: 1,440
• Location: 1
• Anticipated Duration (Months): 50.9
• Patients Per Site Per Month: 28.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Behavioral: Controls-ususal care; Behavioral: Cases-remote patient monitoring prescribed

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1440 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: A Pilot Study of Hypertension Management Using Remote Patient Monitoring- Extended Follow Up Using Matched Cohort Design
• Actual Study Start Date: Nov 18, 2018
• Actual Primary Completion Date: Aug 14, 2022
• Anticipated Study Completion Date: Feb 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Case	Behavioral: Cases-remote patient monitoring prescribed; Cases: patients prescribed remote patient monitoring for blood pressure during routing care delivery
Control	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

Outcome Measures

Primary Outcome Measures

1. Controlling High Blood Pressure (NQF 0018) [18 months]

   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

2. Controlling High Blood Pressure (NQF 0018) [15 months]

   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

3. Controlling High Blood Pressure (NQF 0018) [12 months]

   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

Secondary Outcome Measures

1. Antihypertensive medication intensification [18 months]

   Count of antihypertensive medication drug classes added or increased during the time frame minus the number decreased or discontinued

2. Antihypertensive medication intensification [15 months]

   Count of antihypertensive medication drug classes added or increased during the time frame minus the number decreased or discontinued

3. Antihypertensive medication intensification [12 months]

   Count of antihypertensive medication drug classes added or increased during the time frame minus the number decreased or discontinued

Other Outcome Measures

1. Mean SBP at most recent office visit [18 months]

   Mean SBP at most recent office visit

2. Mean SBP at most recent office visit [15 months]

   Mean SBP at most recent office visit

3. Mean SBP at most recent office visit [12 months]

   Mean SBP at most recent office visit

4. Mean SBP on most recent measurement date (office or out of office) [18 months]

   Mean SBP on most recent measurement date (office or out of office)

5. Mean SBP on most recent measurement date (office or out of office) [15 months]

   Mean SBP on most recent measurement date (office or out of office)

6. Mean SBP on most recent measurement date (office or out of office) [12 months]

   Mean SBP on most recent measurement date (office or out of office)

7. Ambulatory care utilization--office visits [18 months]

   Count of primary care office visits during time frame

8. Ambulatory care utilization--telephone calls [18 months]

   Count of primary care telephone encounters during time frame

9. Ambulatory care utilization--patient portal messages [18 months]

   Count of primary care patient portal encounters during time frame

10. Proportion of patients with an increase in serum creatinine of ≥30% [18 months]

    Proportion of patients with an increase in serum creatinine of ≥30%

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 110 Years
• Sexes Eligible for Study: All

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

-

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• Omron Healthcare Co., Ltd.

Investigators

• Principal Investigator: Stephen D Persell, MD/MPH, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephen Persell, MD, MPH, Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT05562921
• Other Study ID Numbers: STU00213093-3
• First Posted: Oct 3, 2022
• Last Update Posted: Oct 3, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Oct 3, 2022