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临床试验/NCT01670539
NCT01670539已完成不适用

PILOT: Home Telemonitoring for Self-Management Education of Patients With Lung Ca

West Virginia University2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
Changes in Telemonitor Data From Baseline: SpO2

研究概览

简要总结

The purpose of this study is to learn more about using a home machine "Telemonitor" to find problems people with lung cancer may have after being discharged from the hospital and help them manage problems by contacting their healthcare provider.The study hypothesis is that patients with lung CA using short-term (14 days)home telemonitors, educated/coached by nurses on telemonitor data risks/implications for the first two weeks after hospital discharge, will be able to self-report their signs/ symptoms to the clinician resulting in decreased use of costly health care resources over 60 days.

详细描述

All patients in the study will receive usual care after hospital discharge. This study also involves an interview and review of your medical records, and uses the "telemonitor" machine to measure your temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask you to press YES or NO buttons in response to questions on your symptoms such as difficulty breathing. Research nurses will come to your home 3 times and it will take about 30 minutes for each visit for the nurse to record the information using the telemonitor. You will also be asked to fill out a survey about your ability to do activities and your health status. This will take approximately another 30 minutes. You may or may not receive the small telemonitor (about as big as a large book) for 14 days after discharge to provide additional information to the researchers. If you receive the monitor for the full 14 days, you or someone you ask us to train will be taught to use the monitor every morning to collect information on how you will "talk" to you to tell you to put a blood pressure cuff on your arm and an oxygen measurer on your finger. You will step on a scale to take your weight and you will use a forehead sensor to take your temperature. The blood pressure, weight, temperature, your pulse, and your oxygen level will be recorded by the monitor. It will then ask you at least 10 questions and you will push a yes or no button indicating how much difficulty you are having with your daily activities and shortness of breath. The monitor will then connect to your telephone line using a no-charge "800" number and transmit the information to the researchers. If you do not have a phone, a special antenna will be connected to the monitor to transmit the information wirelessly. The nurse will call you every day for the 14 days when you have the monitor. If you do not receive the monitor for the full 14 days, you will still have the monitor used by the nurse when you are visited at least 3 times at home to gather information on how you are doing after hospital discharge. These home monitor visits will be within 2 days after discharge, 2 weeks after discharge, and 2 months after discharge. The main difference is that the monitor will not be left in your home but will be brought by the nurse on each visit. You will also receive a phone call to ask you questions about the study at 1 month after discharge. If you do not have a phone, you will receive another home visit. Whether or not you get the monitor for the full 14 days will be determined randomly by computer before the nurse visits you at home the first time. are doing. The monitor will turn on each day at the same time; the monitor

研究设计

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

入排标准

年龄范围
45 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) patients admitted to the hospital for lung CA as a primary or secondary diagnosis; (2) at least 45 years of age and up to 90 years old; (3) stable mental status and ability to speak (but not necessarily read) the primary language of the region (English).

排除标准

  • are not discharged to home settings
  • are discharged to hospice
  • display a verbalized inability to understand or answer the questionnaires, (4) are disqualified at the discretion of the treating physician, and/or (4) live beyond a 75 mile radius of the hospital.

结局指标

主要结局

Changes in Telemonitor Data From Baseline: SpO2

时间窗: 14 days

Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge

Changes in Telemonitor Data From Baseline: Weight

时间窗: 14 days

Changes in weight measured by telemonitor daily over 14 days after hospital discharge

Changes in Telemonitor Data From Baseline: Pulse Rate

时间窗: 14 days

Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge

Changes in Telemonitor Data From Baseline: Temperature

时间窗: 14 days

Changes in temperature measured by telemonitor daily over 14 days after hospital discharge

Changes in Telemonitor Data From Baseline: Blood Pressure

时间窗: 14 days

Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge

次要结局

  • Changes in Telemonitor Symptoms Recorded From Baseline: Pain(14 days)
  • Changes in Telemonitor Symptoms Recorded From Baseline: Functioning(14 days)
  • Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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