Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)

NCT ID: NCT03562247

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-05-26

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care of IPF

Newly diagnosed patients will continue to receive excellent healthcare as currently given in management of the lung disease

Group Type: ACTIVE_COMPARATOR

Usual Care of IPF

Intervention Type: OTHER

standard of care given to patients with IPF

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.

Group Type: EXPERIMENTAL

Usual Care of IPF

Intervention Type: OTHER

standard of care given to patients with IPF

Telenursing

Intervention Type: OTHER

scheduled phone calls with the patient and care giver

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.

Group Type: EXPERIMENTAL

Usual Care of IPF

Intervention Type: OTHER

standard of care given to patients with IPF

Telenursing

Intervention Type: OTHER

scheduled phone calls with the patient and care giver

Telenursing and Remote Monitoring

Intervention Type: OTHER

scheduled phone calls and home monitoring of physiologic parameters

Interventions

Usual Care of IPF

standard of care given to patients with IPF

Intervention Type: OTHER

Telenursing

scheduled phone calls with the patient and care giver

Intervention Type: OTHER

Telenursing and Remote Monitoring

scheduled phone calls and home monitoring of physiologic parameters

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lisa Lancaster

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Lancaster, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Tenure-1

Identifier Type: -

Identifier Source: org_study_id