NCT05562921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

3.7 years

First QC Date

September 28, 2022

Last Update Submit

March 4, 2024

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Antihypertensive medication intensification

    18 months

  • Antihypertensive medication intensification

    15 months

  • Antihypertensive medication intensification

    12 months

Other Outcomes (10)

  • Mean SBP at most recent office visit

    18 months

  • Mean SBP at most recent office visit

    15 months

  • Mean SBP at most recent office visit

    12 months

  • +7 more other outcomes

Study Arms (2)

Case

Behavioral: Cases-remote patient monitoring prescribed

Control

Behavioral: Controls-ususal care

Interventions

Controls-ususal careBEHAVIORAL

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

Control
Cases-remote patient monitoring prescribedBEHAVIORAL

Cases: patients prescribed remote patient monitoring for blood pressure during routing care delivery

Case

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • Patients whose RPM ordered by non-primary care clinics
  • Patients from the six pilot clinics AND
  • Patients with any RPM order between between November 18, 2018 and August 14, 2021

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Petito LC, Anthony L, Peprah Y, Lee JY, Li J, Sato H, Persell SD. Blood pressure outcomes at 12 months in primary care patients prescribed remote physiological monitoring for hypertension: a prospective cohort study. J Hum Hypertens. 2023 Dec;37(12):1091-1097. doi: 10.1038/s41371-023-00850-w. Epub 2023 Jul 21.

    PMID: 37479812DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Stephen D Persell, MD/MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 3, 2022

Study Start

November 18, 2018

Primary Completion

August 14, 2022

Study Completion

February 14, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)