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Trial record 23 of 106 for:    Recruiting, Not yet recruiting, Available Studies | (idiopathic pulmonary fibrosis)

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

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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Other: Usual Care of IPF Other: Telenursing Other: Telenursing and Remote Monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Telenursing With or Without Remote Monitoring Compared to Usual Care for Patients Newly Diagnosed With Idiopathic Pulmonary Fibrosis.
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2025


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The number of hospitalizations for respiratory illness [ Time Frame: Baseline to 5 years ]
    the number of times patients are hospitalized for a respiratory illness


Secondary Outcome Measures :
  1. the number of respiratory illnesses [ Time Frame: Baseline to 5 years ]
    the number of respiratory illnesses that occur in each arm

  2. the number of acute exacerbations [ Time Frame: Baseline to 5 years ]
    the number of acute exacerbations occurring in each arm by definition

  3. 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

  4. 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'

  5. 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

  6. 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.

  7. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562247


Contacts
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Contact: Wendi Mason, MSN 615-343-7068 wendi.mason@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Wendi Mason, MSN       wendi.mason@vumc.org   
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Wendi Mason, MSN Vanderbilt University Medical Center

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Responsible Party: Wendi Mason, Principle Invesigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03562247     History of Changes
Other Study ID Numbers: Tenure-1
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial