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De klinische studie NCT07397260 (AUTO 2) voor Hypertension (HTN) is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Northwestern-universiteitAutomatically Transmitted Home Blood Pressure and Automated Patient Feedback in Hypertension Care: the AUTO 2 Trial 1.304 Op afstand
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De klinische studie NCT07397260 (AUTO 2) is een interventioneel studie bij Hypertension (HTN) met de status nog niet rekruterend. De inclusie van 1.304 deelnemers start op 1 maart 2026. De studie wordt geleid door Northwestern-universiteit en de voltooiing is gepland op 1 november 2028. Laatste update op ClinicalTrials.gov: 9 februari 2026.
Beknopte samenvatting
The purpose of this study is to evaluate the effectiveness of automatically-generated medical advice to patients about to their home blood pressure monitoring results sent through patient portal messages compared to no automated advice and the effectiveness of automated transmission of remotely-obtained blood pressure values compared to self-reported values on systolic blood pressure at 1-year follow up in patients w...Toon meer
Officiële titel
Effects of Manually Recorded or Automatically Transmitted Home Blood Pressures With or Without Automated Patient Feedback on Hypertension Care
Aandoeningen
Hypertension (HTN)Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:- Liu L, Shih YCT, Strawderman RL, Zhang DW, Johnson BA, Chai HT. Statistical Analysis of Zero-Inflated Nonnegative Continuous Data: A Review. Stat Sci. 2019;34(2):253-279
- HealthMeasures. PROMIS Scale v1.2 - Global Health. 2024. Available at https://www.healthmeasures.net/index.php?option=com_instruments&view=measure&id=778&Itemid=9...
Andere studie-ID's
- AUTO 2
- STU00224615
- R01HL179919 (Subsidie/contract van NIH (VS))
NCT-ID
Startdatum (Werkelijk)
2026-03
Laatste update geplaatst
2026-02-09
Verwachte einddatum
2028-11
Inschrijving (Geschat)
1.304
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Trefwoorden
Hypertension
Remote Patient Monitoring
RPM
Automated transmission
Home blood pressure
Hypertension Care
Remote Patient Monitoring
RPM
Automated transmission
Home blood pressure
Hypertension Care
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Factorieel
Blindering
Dubbelblind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Actieve comparatorEnhanced Usual Care Participants receive a blood pressure monitor and are encouraged to enter blood pressure results into their EHR patient portal. | Self report of home measured blood pressure via patient EHR portal Participants will be provided with a home blood pressure monitor and method to use the EHR portal to enter home collected blood pressures into the EHR. |
Actieve comparatorAutomated Transmission of Remotely Monitored Blood Pressure Participants receive a blood pressure monitor and an application to directly transmit measurements to their EHR record. | Automated Transmission of Remotely Measured Blood Pressure Participants will be provided with a blood pressure monitor and application to automatically transmit home blood pressures to their EHR record. |
Actieve comparatorAutomated Patient Feedback on Self Blood Pressure Monitoring Participants receive a blood pressure monitor and are encouraged to enter blood pressure results into their EHR patient portal. Participants receive messages through the EHR patient portal about their home blood pressure results. | Self report of home measured blood pressure via patient EHR portal Participants will be provided with a home blood pressure monitor and method to use the EHR portal to enter home collected blood pressures into the EHR. Automated feedback about home blood pressure results Patients will received periodic messages about the results of their home blood pressure monitoring with suggestions to consult with clinical care team when indicated. |
Actieve comparatorAutomated Transmission of Remotely Monitored Blood Pressure and Automated Feedback Participants receive a blood pressure monitor and an application to directly transmit measurements to their EHR record. Participants receive messages through the EHR patient portal about their home blood pressure results. | Automated feedback about home blood pressure results Patients will received periodic messages about the results of their home blood pressure monitoring with suggestions to consult with clinical care team when indicated. Automated Transmission of Remotely Measured Blood Pressure Participants will be provided with a blood pressure monitor and application to automatically transmit home blood pressures to their EHR record. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Systolic blood pressure at 12 months | 12 months |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Systolic blood pressure at 18 months | 18 months | |
Antihypertensive medication changes from baseline | From baseline to 12 months and 18 months | |
Antihypertensive medication classes prescribed, standardized count | 12 months and 18 months | |
Medication adherence (patient report, Domains of Subjective Extent of Nonadhernece) | 12 months and 18 months | |
Diastolic blood pressure | 12 months and 18 months | |
Blood pressure <130/80 mm Hg | 12 months and 18 months | |
Blood pressure <140/90 mm Hg | 12 months and and 18 months |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Age 18-84 years at enrollment date
- Receives hypertension care primarily from a participating clinician
- Blood pressure on the two most recent days when ambulatory clinic blood pressure was obtained prior to patient identification to was ≥140 mm Hg systolic and/or ≥90 diastolic or last ambulatory clinic blood pressure was ≥150 mm Hg systolic and/or ≥95 diastolic
- Currently has or is willing to obtain a patient portal account from NM.
- Dementia,
- Nursing home resident,
- Stage 5 chronic kidney disease or renal replacement therapy,
- Pregnancy,
- Receiving hospice,
- Not planning to continue to receive hypertension care from NM clinician for the next year,
- Planning to move from the region in the next year,
- Planning to change clinician treating their hypertension in the next year,
- Medical or psychological reason they cannot perform home blood pressure monitoring.
- Known to have average home blood pressure or most recent home blood pressure value of <130/80 mm Hg.
CLINICIAN PARTICIPANT INCLUSION Physician, advanced practice nurse or physician assistant working at a Northwestern Medicine ambulatory primary care site that cares for adults with hypertension (family medicine, internal medicine, medicine/pediatrics, and ambulatory geriatrics sites).
CLINICIAN PARTICIPANT EXCLUSION
- Primary care physicians and clinicians not willing for their patients to participate in study
- Planning to depart NM within the next year
- Not willing to receive patients' out-of-office blood pressure data
Northwestern-universiteitNationaal Hart-, Long- en Bloedinstituut, VS747 actieve klinische studies om te verkennenVerantwoordelijke instantie
Stephen Persell, MD, MPH, Hoofdonderzoeker, Professor of Medicine, Northwestern University
Centraal Contactpersoon
Contact: Yaw Amofa Peprah, MPH, 3125032753, [email protected]
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