Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)

NCT03562247 | Terminated Results

• 1 other identifier: Tenure-1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• The Number Hospitalization Events Resulting From a Respiratory Illness

  The number hospitalization events resulting from a respiratory illness

  Baseline to 21 months

Secondary Outcomes (7)

• 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 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

• The Severity of Depression as Measured by the Adapted Mental Health America Depression Screening Tool

  Up to 21 months

Study Arms (3)

Usual Care of IPF

ACTIVE COMPARATOR

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

Other: Usual Care of IPF

Telenursing

EXPERIMENTAL

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.

Other: Usual Care of IPF; Other: Telenursing

Telenursing and Remote Monitoring

EXPERIMENTAL

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.

Other: Usual Care of IPF; Other: Telenursing; Other: Telenursing and Remote Monitoring

Interventions

Usual Care of IPF OTHER

standard of care given to patients with IPF

Telenursing; Telenursing and Remote Monitoring; Usual Care of IPF

Telenursing OTHER

scheduled phone calls with the patient and care giver

Telenursing; Telenursing and Remote Monitoring

Telenursing and Remote Monitoring OTHER

scheduled phone calls and home monitoring of physiologic parameters

Telenursing and Remote Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 3.
• Willingness to complete and monitor daily health assessments, if assigned to Arm 3.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Telenursing

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Nursing; Professional Practice; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient Care Management

Limitations and Caveats

This study was terminated early due to the original PI leaving the institution. The new PI never enrolled any participants and the study was closed.

Results Point of Contact

• Title: Lisa Lancaster, MD
• Organization: Vanderbilt University Medical Center

lisa.lancaster@vumc.org

615-322-2386

Study Officials

• Lisa Lancaster, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 19, 2018
• Study Start: August 1, 2018
• Primary Completion: May 26, 2020
• Study Completion: May 26, 2020
• Last Updated: January 16, 2024
• Results First Posted: January 16, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)