Clinical trial NCT03562247: Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)
Official title: Telenursing With or Without Remote Monitoring Compared to Usual Care for Patients Newly Diagnosed With Idiopathic Pulmonary Fibrosis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. Willingness to participate in phone calls/video calls with the nurse practitioner or nurse case manager, if assigned to Arm 2 or Arm 3.
4. Willingness to complete and monitor daily health assessments, if assigned to Arm 3.
5. Willingness to share objective data via a provided electronic web-based portal, electronically via email, fax, or regular mail.
6. Willingness to notify, or allow notification, of study involvement with local pulmonary practices.

Exclusion Criteria:

1. Diagnosed with any other interstitial lung disease.
2. Diagnosed and began treatment \> 6 months before the VUMC-based diagnosis date.

Primary outcomes:
measure: The Number Hospitalization Events Resulting From a Respiratory Illness
timeFrame: Baseline to 21 months
Secondary outcomes:
measure: The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF)
timeFrame: Baseline to 21 months
measure: The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)
timeFrame: Baseline to 21 months
measure: The Number of Days From Idiopathic Pulmonary Fibrosis (IPF) Diagnosis to First Hospitalization for Respiratory Illness
timeFrame: Baseline to 21 months
measure: The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: Baseline to 21 months
measure: The Severity of Depression as Measured by the Adapted Mental Health America Depression Screening Tool
timeFrame: Up to 21 months
measure: The Severity of Anxiety as Measured by the Adapted New Zealand Health Promotion Agency Anxiety Self-Test
timeFrame: Baseline to 21 months
measure: The Percentage of Change in Forced Vital Capacity (FVC) Measured by Spirometry
timeFrame: Baseline to 21 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Lisa Lancaster, MD
role: PRINCIPAL_INVESTIGATOR
References: