Back to resultsTelenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care of IPF
Telenursing
Telenursing and Remote Monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Idiopathic Pulmonary Fibrosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Diagnosed with any other interstitial lung disease.
- Diagnosed and began treatment > 6 months before the VUMC-based diagnosis date.
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Usual Care of IPF
Telenursing
Telenursing and Remote Monitoring
Arm Description
Newly diagnosed patients will continue to receive excellent healthcare as currently given in management of the lung disease
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.
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.
Outcomes
Primary Outcome Measures
The number of hospitalizations for respiratory illness
the number of times patients are hospitalized for a respiratory illness
Secondary Outcome Measures
the number of respiratory illnesses
the number of respiratory illnesses that occur in each arm
the number of acute exacerbations
the number of acute exacerbations occurring in each arm by definition
The length of time to first hospitalization for respiratory illness
The days from the date of diagnosis to the date of first hospitalization in each arm
the presence and degree of dyspnea as measured by the modified Medical Research Council dyspnea score
a scale that measures the degree of shortness of breath at that time in each arm; range 0-4 with 0 being 'no shortness of breath' and 4 being 'maximal shortness of breath'
the presence and degree of depression as measured by the Depression Self-screen
a questionnaire that scores patient-reported symptoms of depression in each arm; range 0-24 where 0-6 is none to mild depression and 16-24 is severe depression
the presence and degree of anxiety as measured by the Anxiety Self-screen
a questionnaire that scores patient-reported symptoms of anxiety in each arm; range is 0-24, with 0-8 being none to mild anxiety and 16-24 is severe anxiety.
the comparison of home spirometry to clinic-based spirometry
home-based spirometry measure of forced vital capacity (FVC) as compared to clinic-based FVC in the Telenursing with Remote Monitoring Arm
Full Information
NCT ID
NCT03562247
First Posted
June 14, 2018
Last Updated
February 3, 2021
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03562247
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care of IPF
Arm Type
Active Comparator
Arm Description
Newly diagnosed patients will continue to receive excellent healthcare as currently given in management of the lung disease
Arm Title
Telenursing
Arm Type
Experimental
Arm Description
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.
Arm Title
Telenursing and Remote Monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care of IPF
Intervention Description
standard of care given to patients with IPF
Intervention Type
Other
Intervention Name(s)
Telenursing
Intervention Description
scheduled phone calls with the patient and care giver
Intervention Type
Other
Intervention Name(s)
Telenursing and Remote Monitoring
Intervention Description
scheduled phone calls and home monitoring of physiologic parameters
Primary Outcome Measure Information:
Title
The number of hospitalizations for respiratory illness
Description
the number of times patients are hospitalized for a respiratory illness
Time Frame
Baseline to 5 years
Secondary Outcome Measure Information:
Title
the number of respiratory illnesses
Description
the number of respiratory illnesses that occur in each arm
Time Frame
Baseline to 5 years
Title
the number of acute exacerbations
Description
the number of acute exacerbations occurring in each arm by definition
Time Frame
Baseline to 5 years
Title
The length of time to first hospitalization for respiratory illness
Description
The days from the date of diagnosis to the date of first hospitalization in each arm
Time Frame
Baseline to 5 years
Title
the presence and degree of dyspnea as measured by the modified Medical Research Council dyspnea score
Description
a scale that measures the degree of shortness of breath at that time in each arm; range 0-4 with 0 being 'no shortness of breath' and 4 being 'maximal shortness of breath'
Time Frame
Baseline to 5 years
Title
the presence and degree of depression as measured by the Depression Self-screen
Description
a questionnaire that scores patient-reported symptoms of depression in each arm; range 0-24 where 0-6 is none to mild depression and 16-24 is severe depression
Time Frame
Baseline to 5 years
Title
the presence and degree of anxiety as measured by the Anxiety Self-screen
Description
a questionnaire that scores patient-reported symptoms of anxiety in each arm; range is 0-24, with 0-8 being none to mild anxiety and 16-24 is severe anxiety.
Time Frame
Baseline to 5 years
Title
the comparison of home spirometry to clinic-based spirometry
Description
home-based spirometry measure of forced vital capacity (FVC) as compared to clinic-based FVC in the Telenursing with Remote Monitoring Arm
Time Frame
Baseline to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Diagnosed with any other interstitial lung disease.
Diagnosed and began treatment > 6 months before the VUMC-based diagnosis date.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Lancaster, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)
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