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临床试验/NCT04294303
NCT04294303已完成不适用

Heart Failure Self-Management Using a Mobile Web-Based Telemonitoring System- Impact on Hospital Readmissions and Quality of Life SELF-e HF

Danbury Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Rate of hospital readmission for heart failure

研究概览

简要总结

Heart failure is a major public health problem worldwide. Heart failure is one of the most common causes for hospitalizations among people over 65 years of age in the United States. Nationwide, approximately 25% of patients admitted to a hospital for heart failure are readmitted to a hospital within 30 days.Multiple transitional care interventions, including telemonitoring, aimed to decrease hospital readmission rates and improve quality of life in heart failure (HF) patients have been explored. Most studies evaluated effectiveness of telemonitoring used in conjunction with other interventions. In this study, investigators studied the role of a potentially cost-effective, telemonitoring program in reducing readmissions and improving quality of life among patients admitted with HF exacerbation in a teaching hospital. They aimed to determine impact of a standalone telemonitoring system.

Primary outcome: Rate of hospital readmission for heart failure Secondary outcomes: Quality of life, Perceived effect of the intervention on heart-failure related care

详细描述

60 patients will be recruited for this study. After signing the consent form, participant will be randomized to receive usual care (i.e. they will get the current standard care for patients with heart failure) or usual care and participation in the iGetBetter program. Participant will complete a questionnaire in the hospital about their quality of life. iGetBetter group will be given a Bluetooth-equipped scale, blood pressure cuff, and a tablet with a data plan. Participant will check their weight and blood pressure at home daily, using the equipment provided. This information will be sent via the internet to iGetBetter's web server, where the data will be temporarily stored. The data will be monitored by the physician researcher. If their blood pressure is high (e.g. greater than or equal to 140/90 for two days in a row) or they gain a significant amount of weight (e.g. 2 pounds in two days), the study team will be automatically notified. A member of the study team will alert participant cardiologist and the cardiologist will have the option to make any recommendations, such as contacting the subject to schedule an office visit.

Total participation in this study will last 45 days after patient is discharged from the hospital.

Regardless of the assigned group, participant will be asked to complete two questionnaires after 45 days. A member of the research team will contact participant by phone to complete these questionnaires. One of these questionnaires will investigate their quality of life; the other will assess how participant feel the care they have received has affected their health. Patients assigned to the iGetBetter group will also complete a third survey about their satisfaction with the program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • 18 years of age and older
  • Admitted to Danbury Hospital with heart failure
  • NYHA functional class II-IV

排除标准

  • Not agreeable to participate in the study
  • ESRD on HD
  • Severe COPD (O2/steroid dependent?)
  • Pregnancy
  • Hospice patients/bed bound patients
  • Severe valvular disease, or recent valvular intervention (within 1 year) or planned valvular intervention.
  • Expected to be transferred to another acute care hospital
  • Solid organ transplant recipient or listed for transplant, recipient of left ventricular assist device or planned to receive one
  • Homeless participants
  • Active psychiatric disorders, addiction

结局指标

主要结局

Rate of hospital readmission for heart failure

时间窗: 45 days after enrollment

次要结局

  • Quality of life: questioninaire(45 days after enrollment)
  • Perceived effect of the intervention on heart-failure related care(45 days after enrollment)

研究者

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

Ira Galin

Associate Director of the vascular Medicine Program

Danbury Hospital

研究点 (2)

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