Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)

March 31, 2023 updated by: Lisa Lancaster, Vanderbilt University Medical Center

Telenursing With or Without Remote Monitoring Compared to Usual Care for Patients Newly Diagnosed With Idiopathic Pulmonary Fibrosis.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual Care of IPF
Newly diagnosed patients will continue to receive excellent healthcare as currently given in management of the lung disease
Other: Usual Care of IPF
standard of care given to patients with IPF
Experimental: 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.
Other: Usual Care of IPF
standard of care given to patients with IPF
Other: Telenursing
scheduled phone calls with the patient and care giver
Experimental: 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.
Other: Usual Care of IPF
standard of care given to patients with IPF
Other: Telenursing
scheduled phone calls with the patient and care giver
Other: Telenursing and Remote Monitoring
scheduled phone calls and home monitoring of physiologic parameters

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Number Hospitalization Events Resulting From a Respiratory Illness
Time Frame: Baseline to 21 months
The number hospitalization events resulting from a respiratory illness
Baseline to 21 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF)
Time Frame: Baseline to 21 months
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)
Time Frame: Baseline to 21 months
The Number of Acute Exacerbations of IPF
Baseline to 21 months
The Number of Days From Idiopathic Pulmonary Fibrosis (IPF) Diagnosis to First Hospitalization for Respiratory Illness
Time Frame: Baseline to 21 months
The total combined number of days for all participants in each arm from the date of IPF diagnosis to the date of first hospitalization for respiratory illness.
Baseline to 21 months
The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale
Time Frame: Baseline to 21 months
Dyspnea (shortness of breath) was assessed using the mMRC, a single item (0-4) scale assessing current level of dyspnea. The mMRC comprised of five statements that describe almost the entire range of respiratory disability from none (Grade 0) to almost complete incapacity (Grade 4). The mMRC categorized participants into low dyspnea (Grades 0-1) and high dyspnea (Grades 2-4).
Baseline to 21 months
The Severity of Depression as Measured by the Adapted Mental Health America Depression Screening Tool
Time Frame: Up to 21 months
The adapted Mental Health America Depression Screening Tool is an 8 question self-administered questionnaire that scores patient-reported symptoms of depression. The possible score for each question ranges from 0-3. The total questionnaire score range is 0-24. Total scores of 0-6 indicate 'none to mild depression' and scores of 16-24 indicate 'severe depression'. Data from participant visits at baseline, 3 months, 9 months, 15 months and 21 months were combined and averaged to calculate a single value.
Up to 21 months
The Severity of Anxiety as Measured by the Adapted New Zealand Health Promotion Agency Anxiety Self-Test
Time Frame: Baseline to 21 months
The adapted New Zealand Health Promotion Agency Anxiety Self-Test is an 8 question self-administered questionnaire that scores patient-reported symptoms of anxiety. The possible score for each question ranges from 0-3. The total questionnaire score range is 0-24. Total scores of 0-8 indicate 'none to mild anxiety' and scores of 16-24 indicate 'severe anxiety'. Data from participant visits at baseline, 3 months, 9 months, 15 months and 21 months were combined and averaged to calculate a single value.
Baseline to 21 months
The Percentage of Change in Forced Vital Capacity (FVC) Measured by Spirometry
Time Frame: Baseline to 21 months
The percentage of change in home-measured forced vital capacity (FVC) compared to clinic-measured FVC via spirometry
Baseline to 21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa Lancaster, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 26, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 26, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Tenure-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings