Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03562247
• Other study ID #: Tenure-1
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: May 26, 2020

Study information

• Verified date: March 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: May 26, 2020
• Est. primary completion date: May 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• Usual Care of IPF
standard of care given to patients with IPF
• Telenursing
scheduled phone calls with the patient and care giver
• Telenursing and Remote Monitoring
scheduled phone calls and home monitoring of physiologic parameters

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number Hospitalization Events Resulting From a Respiratory Illness	The number hospitalization events resulting from a respiratory illness	Baseline to 21 months
Secondary	The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF)	The number of respiratory events that indicate a worsening of Idiopathic Pulmonary Fibrosis (IPF)	Baseline to 21 months
Secondary	The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)	The Number of Acute Exacerbations of IPF	Baseline to 21 months
Secondary	The Number of Days From Idiopathic Pulmonary Fibrosis (IPF) Diagnosis to First Hospitalization for Respiratory Illness	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
Secondary	The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale	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
Secondary	The Severity of Depression as Measured by the Adapted Mental Health America Depression Screening Tool	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
Secondary	The Severity of Anxiety as Measured by the Adapted New Zealand Health Promotion Agency Anxiety Self-Test	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
Secondary	The Percentage of Change in Forced Vital Capacity (FVC) Measured by Spirometry	The percentage of change in home-measured forced vital capacity (FVC) compared to clinic-measured FVC via spirometry	Baseline to 21 months