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临床试验/NCT03698890
NCT03698890Unknown不适用

Evaluation of Clinical Pathways for Patients With Hypertension on Follow-up in the Polyclinics

National Healthcare Group Polyclinics2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2018年9月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
240
试验地点
2
主要终点
Blood pressure control

研究概览

简要总结

This study evaluates the impact of the use of a technology-enabled home blood pressure monitor amongst hypertensive patients in primary care. Half of the patients will receive the blood pressure monitor for home monitoring, while the other half will receive usual care at the polyclinic. The hypothesis is tele-monitoring along with nurse led tele-support and medical review (i.e. tele-treatment) can enhance primary care management of hypertension by improving patient outcomes and reducing health costs.

详细描述

A literature review on telemedicine in primary care indicated that tele-monitoring can enhance primary care management of hypertension (HT) by improving patient outcomes and reducing health costs. In addition, technology-enabled blood pressure (BP) self-monitoring interventions have even better BP control outcomes if (i) nurse led tele-support and (ii) medication review (i.e. tele-treatment) are added.

This study comprises 2 phases:

Phase 1: Intervention phase This will be an open label (unblinded), parallel, non-randomized, quasi-experimental study conducted within 1 study site. Patients who are under the care of 2 clinical teams, called teamlets (comprising 2 family physicians, a care coordinator and a care manager who is a nurse), will be recruited into the study.

Patients under the care of 1 teamlet will be allocated to the intervention group, while those under the care of the other teamlet will be allocated to the usual care group.

One key modality for this study will be the use of a network-based home blood pressure monitor to provide patient-led tele-monitoring for BP levels for patients in the intervention group. The monitor will be loaned to patients in the intervention group, who will be asked to monitor their blood pressure at least once every week using the network based home blood pressure monitor, which automatically uploads measured blood pressure readings to the MyHealthSentinel (MHS) portal for care managers (CM) in the teamlet to review blood pressure readings.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients
  • Patients with hypertension only, or hypertension and hyperlipidemia
  • Patients who are cared for by teamlets
  • Patients who are technology savvy and are able and willing to use telemedicine devices, or have a family member who is willing to assist in using telemedicine for blood pressure control
  • Clinic teams who are directly involved in patient care

排除标准

  • Patients who have cognitive impairment
  • Pregnant patients
  • Patients with hypertension and other chronic illnesses other than hyperlipidemia, such as diabetes.
  • Patients with a history of ischemic heart disease, congestive heart failure, stroke, transient ischemic attack, atrial fibrillation and renal impairment.

研究组 & 干预措施

Control

No Intervention

Usual care of 3 to 6-monthly clinic visit

Intervention

Experimental

Network-based home blood pressure monitor (Fora P20b Blood Pressure Monitor) and telephone consult with care team

干预措施: Network-based home blood pressure monitor (Device)

结局指标

主要结局

Blood pressure control

时间窗: 6 months

Change in systolic and diastolic blood pressure (in mmHg) after 6 months. Readings will be obtained monthly from the MHS portal.

次要结局

  • Type of medications prescribed to participants(6 months)
  • Medication adherence(6 months)
  • Time to blood pressure control(6 months)
  • Healthcare costs incurred by participants(6 & 12 months)
  • Quality of life of participants(6 months)
  • Patient satisfaction(6 months)
  • Proportion of participants with controlled blood pressure(6 months)
  • Healthcare utilization of participants(6 & 12 months)
  • Number of medications prescribed to participants(6 months)

研究者

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

Valerie Teo

Family Physician, Associate Consultant, Deputy Head, Ang Mo Kio Polyclinic

National Healthcare Group Polyclinics

研究点 (2)

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