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临床试验/NCT07397260
NCT07397260Enrolling By Invitation不适用

Effects of Manually Recorded or Automatically Transmitted Home Blood Pressures With or Without Automated Patient Feedback on Hypertension Care

Northwestern University1 个研究点 分布在 1 个国家目标入组 1,304 人开始时间: 2026年5月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,304
试验地点
1
主要终点
Systolic blood pressure at 12 months

研究概览

简要总结

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 with uncontrolled hypertension whose physicians or advance practice providers provide primary care at Northwestern Medicine. Persistence of effects through 18 months will also be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Automated Transmission of Remotely Monitored Blood Pressure

Active Comparator

Participants receive a blood pressure monitor and an application to directly transmit measurements to their EHR record.

干预措施: Automated Transmission of Remotely Measured Blood Pressure (Other)

Enhanced Usual Care

Active Comparator

Participants receive a blood pressure monitor and are encouraged to enter blood pressure results into their EHR patient portal.

干预措施: Self report of home measured blood pressure via patient EHR portal (Other)

Automated Patient Feedback on Self Blood Pressure Monitoring

Active Comparator

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.

干预措施: Self report of home measured blood pressure via patient EHR portal (Other)

Automated Patient Feedback on Self Blood Pressure Monitoring

Active Comparator

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.

干预措施: Automated feedback about home blood pressure results (Other)

Automated Transmission of Remotely Monitored Blood Pressure and Automated Feedback

Active Comparator

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.

干预措施: Automated feedback about home blood pressure results (Other)

Automated Transmission of Remotely Monitored Blood Pressure and Automated Feedback

Active Comparator

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.

干预措施: Automated Transmission of Remotely Measured Blood Pressure (Other)

结局指标

主要结局

Systolic blood pressure at 12 months

时间窗: 12 months

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Persell, MD, MPH

Professor of Medicine

Northwestern University

研究点 (1)

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