Telenursing With or Without Remote Monitoring Compared to Usual Care for Patients Newly Diagnosed With Idiopathic Pulmonary Fibrosis.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- The Number Hospitalization Events Resulting From a Respiratory Illness
研究概览
简要总结
Numerous studies show that remote monitoring and/or telenursing improves outcomes for patients especially those with chronic diseases. It is proposed that structured telenursing with non-invasive home monitoring of forced vital capacity and oxygen saturation in newly diagnosed patients with IPF will decrease hospitalizations for respiratory illness, increase compliance with therapies, and ultimately increase quality of life.
详细描述
Patients undergoing evaluation for and who are diagnosed with Idiopathic Pulmonary Fibrosis at Vanderbilt Medical Center from August 1, 2018, will be asked to participate. If agrees, and after signing the consent form, patients will be randomized into one of three arms: Usual Care, Usual Care with Telenursing, or Usual Care with Telenursing and Remote Monitoring. Patients will be asked to remain in the study for a minimum of three years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be newly diagnosed with IPF by a Vanderbilt pulmonologist according to the 2011 American Thoracic Society Guidelines. If the patient has been diagnosed by local pulmonologist and started on FDA-approved treatment, then must have been started on treatment within 6 months of Vanderbilt University Medical Center-based diagnosis.
- •Willingness to complete Quality of Life and Compliance Questionnaires at 6-month intervals either via an on-line process (RED Cap survey) or paper-based.
- •Willingness to participate in phone calls/video calls with the nurse practitioner or nurse case manager, if assigned to Arm 2 or Arm
- •Willingness to complete and monitor daily health assessments, if assigned to Arm
- •Willingness to share objective data via a provided electronic web-based portal, electronically via email, fax, or regular mail.
- •Willingness to notify, or allow notification, of study involvement with local pulmonary practices.
排除标准
- •Diagnosed with any other interstitial lung disease.
- •Diagnosed and began treatment > 6 months before the VUMC-based diagnosis date.
研究组 & 干预措施
Usual Care of IPF
Newly diagnosed patients will continue to receive excellent healthcare as currently given in management of the lung disease
干预措施: Usual Care of IPF (Other)
Telenursing
Patients will receive usual care with structured phone calls from the nurse practitioner and/or case manager occuring more frequently earlier in the diagnosis to help the patient and care giver understand all aspects of the disease and it time will evolve to managing symptoms outside of out-patient clinic visits.
干预措施: Usual Care of IPF (Other)
Telenursing
Patients will receive usual care with structured phone calls from the nurse practitioner and/or case manager occuring more frequently earlier in the diagnosis to help the patient and care giver understand all aspects of the disease and it time will evolve to managing symptoms outside of out-patient clinic visits.
干预措施: Telenursing (Other)
Telenursing and Remote Monitoring
Patients will receive usual care with telenursing and will be given a hand held spirometer and puse oximeter and be asked to take daily measurements and report these via an electronic HIPAA approved secured platform for evaluation by the telenursing team.
干预措施: Usual Care of IPF (Other)
Telenursing and Remote Monitoring
Patients will receive usual care with telenursing and will be given a hand held spirometer and puse oximeter and be asked to take daily measurements and report these via an electronic HIPAA approved secured platform for evaluation by the telenursing team.
干预措施: Telenursing (Other)
Telenursing and Remote Monitoring
Patients will receive usual care with telenursing and will be given a hand held spirometer and puse oximeter and be asked to take daily measurements and report these via an electronic HIPAA approved secured platform for evaluation by the telenursing team.
干预措施: Telenursing and Remote Monitoring (Other)
结局指标
主要结局
The Number Hospitalization Events Resulting From a Respiratory Illness
时间窗: Baseline to 21 months
The number hospitalization events resulting from a respiratory illness
次要结局
- The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF)(Baseline to 21 months)
- The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)(Baseline to 21 months)
- The Percentage of Change in Forced Vital Capacity (FVC) Measured by Spirometry(Baseline to 21 months)
- The Severity of Depression as Measured by the Adapted Mental Health America Depression Screening Tool(Up to 21 months)
- The Severity of Anxiety as Measured by the Adapted New Zealand Health Promotion Agency Anxiety Self-Test(Baseline to 21 months)
- The Number of Days From Idiopathic Pulmonary Fibrosis (IPF) Diagnosis to First Hospitalization for Respiratory Illness(Baseline to 21 months)
- The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale(Baseline to 21 months)
研究者
Lisa Lancaster
Professor of Medicine
Vanderbilt University Medical Center