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Completed

NCT Number: NCT05562921

Hypertension Management Using Remote Patient Monitoring

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controls-ususal care

Behavioral

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

Behavioral

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

Primary outcomes

  1. Controlling High Blood Pressure (NQF 0018)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Antihypertensive medication intensification

    Time frame: 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

    Time frame: 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

    Time frame: 12 months

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

Other outcomes

  1. Mean SBP at most recent office visit

    Time frame: 18 months

    Mean SBP at most recent office visit

  2. Mean SBP at most recent office visit

    Time frame: 15 months

    Mean SBP at most recent office visit

  3. Mean SBP at most recent office visit

    Time frame: 12 months

    Mean SBP at most recent office visit

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 12 months

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

  7. Ambulatory care utilization--office visits

    Time frame: 18 months

    Count of primary care office visits during time frame

  8. Ambulatory care utilization--telephone calls

    Time frame: 18 months

    Count of primary care telephone encounters during time frame

  9. Ambulatory care utilization--patient portal messages

    Time frame: 18 months

    Count of primary care patient portal encounters during time frame

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

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Omron Healthcare Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Oct 3, 2022
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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