HypertensionNCT05562921
Hypertension Management Using Remote Patient Monitoring
An observational study of Hypertension, run by Northwestern University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Cases-remote patient monitoring prescribed
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,440 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2018to 14 Feb 2023
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Hypertension Management Using Remote Patient Monitoring- Extended Follow Up Using Matched Cohort Design
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.
- Conditions
- Hypertension
- Being tested
- Controls-ususal care, Cases-remote patient monitoring prescribed
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controls-ususal careBehavioural
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 prescribedBehavioural
Cases: patients prescribed remote patient monitoring for blood pressure during routing care delivery
| Study group | Role | What they receive |
|---|---|---|
| Case | Not described Receives: Behavioral: Cases-remote patient monitoring prescribed | |
| Control | Not described Receives: Behavioral: Controls-ususal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 12 months
Secondary outcomes (3)
Antihypertensive medication intensification
Count of antihypertensive medication drug classes added or increased during the time frame minus the number decreased or discontinued
Measured: 18 months
Antihypertensive medication intensification
Count of antihypertensive medication drug classes added or increased during the time frame minus the number decreased or discontinued
Measured: 15 months
Antihypertensive medication intensification
Count of antihypertensive medication drug classes added or increased during the time frame minus the number decreased or discontinued
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start18 Nov 2018
- Primary completion14 Aug 2022
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,440 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Omron Healthcare Co., Ltd.
- Responsible party
- Principal investigator, Stephen Persell, MD, MPH, Northwestern University
- Investigators
- Stephen D Persell, MD/MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562921
- Sponsor's protocol ID
- STU00213093-3
- Status last verified
- Mar 2024
- First submitted
- 28 Sep 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Winkler CJ, Petito LC, Peprah Y, Lee JY, Sato H, Persell SD. Hypertension Medication Changes in Patients Prescribed Remote Monitoring. Am J Hypertens. 2026 Apr 1;39(4):563-569. doi: 10.1093/ajh/hpaf228.
PubMed 41428418Petito 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.
PubMed 37479812
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Hypertension Management Using Remote Patient Monitoring- Extended Follow Up Using Matched Cohort Design
- ClinicalTrials.gov ID
- NCT05562921
- Acronym / sponsor ID
- STU00213093-3
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,440 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Omron Healthcare Co., Ltd.
- Study start
- 18 Nov 2018 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Behavioral: Cases-remote patient monitoring prescribed |
| Control | – | Behavioral: Controls-ususal care |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controls-ususal careControls: patients who did not receive remote patient monitoring for blood pressure prescribed during routine care delivery, with multivariable matching to cases | Behavioural | Control |
| Cases-remote patient monitoring prescribedCases: patients prescribed remote patient monitoring for blood pressure during routing care delivery | Behavioural | Case |
Primary outcome
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
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
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
3 secondary outcomes
Antihypertensive medication intensification
Time frame: 18 months
Antihypertensive medication intensification
Time frame: 15 months
Antihypertensive medication intensification
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Derived from this study: PubMed 41428418Winkler CJ, Petito LC, Peprah Y, Lee JY, Sato H, Persell SD. Hypertension Medication Changes in Patients Prescribed Remote Monitoring. Am J Hypertens. 2026 Apr 1;39(4):563-569. doi: 10.1093/ajh/hpaf228.
- Derived from this study: PubMed 37479812Petito 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.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D Persell, MD/MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Controlling High Blood Pressure (NQF 0018) (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562921, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.