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Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)

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ClinicalTrials.gov Identifier: NCT03562247
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Wendi Mason, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE June 14, 2018
First Posted Date  ICMJE June 19, 2018
Last Update Posted Date August 6, 2018
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
The number of hospitalizations for respiratory illness [ Time Frame: Baseline to 5 years ]
the number of times patients are hospitalized for a respiratory illness
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03562247 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
  • the number of respiratory illnesses [ Time Frame: Baseline to 5 years ]
    the number of respiratory illnesses that occur in each arm
  • the number of acute exacerbations [ Time Frame: Baseline to 5 years ]
    the number of acute exacerbations occurring in each arm by definition
  • The length of time to first hospitalization for respiratory illness [ Time Frame: Baseline to 5 years ]
    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 [ Time Frame: Baseline to 5 years ]
    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 [ Time Frame: Baseline to 5 years ]
    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 [ Time Frame: Baseline to 5 years ]
    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 [ Time Frame: Baseline to 5 years ]
    home-based spirometry measure of forced vital capacity (FVC) as compared to clinic-based FVC in the Telenursing with Remote Monitoring Arm
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)
Official Title  ICMJE Telenursing With or Without Remote Monitoring Compared to Usual Care for Patients Newly Diagnosed With Idiopathic Pulmonary Fibrosis.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Usual Care of IPF
    Newly diagnosed patients will continue to receive excellent healthcare as currently given in management of the lung disease
    Intervention: Other: Usual Care of 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.
    Interventions:
    • Other: Usual Care of IPF
    • Other: Telenursing
  • 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.
    Interventions:
    • Other: Usual Care of IPF
    • Other: Telenursing
    • Other: Telenursing and Remote Monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2025
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wendi Mason, MSN 615-343-7068 wendi.mason@vumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03562247
Other Study ID Numbers  ICMJE Tenure-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wendi Mason, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wendi Mason, MSN Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP