Idiopathic Pulmonary FibrosisNCT03562247
Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)
A study testing Telenursing and Telenursing and Remote Monitoring in people with Idiopathic Pulmonary Fibrosis, run by Vanderbilt University Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Telenursing and Telenursing and Remote Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 26 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosed with any other interstitial lung disease.
- Diagnosed and began treatment > 6 months before the VUMC-based diagnosis date.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Usual Care of IPF, Telenursing, Telenursing and Remote Monitoring
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care of IPFOther
standard of care given to patients with IPF
TelenursingOther
scheduled phone calls with the patient and care giver
Telenursing and Remote MonitoringOther
scheduled phone calls and home monitoring of physiologic parameters
| Study group | Role | What they receive |
|---|---|---|
| Usual Care of IPF | Active comparator | Newly diagnosed patients will continue to receive excellent healthcare as currently given in management of the lung disease Receives: Other: Usual Care of IPF |
| Telenursing | Experimental | 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. Receives: Other: Usual Care of IPF; Other: Telenursing |
| Telenursing and Remote Monitoring | Experimental | 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. Receives: Other: Usual Care of IPF; Other: Telenursing; Other: Telenursing and Remote Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number Hospitalization Events Resulting From a Respiratory Illness
The number hospitalization events resulting from a respiratory illness
Measured: Baseline to 21 months
Secondary outcomes (7)
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)
Measured: Baseline to 21 months
The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)
The Number of Acute Exacerbations of IPF
Measured: Baseline to 21 months
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.
Measured: Baseline to 21 months
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).
Measured: Baseline to 21 months
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.
Measured: Up to 21 months
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.
Measured: Baseline to 21 months
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
Measured: Baseline to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Aug 2018
- Primary completion26 May 2020
- Study completion26 May 2020
Why it stopped: Principal Investigator left the institution and the study was closed with the IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Lancaster, Vanderbilt University Medical Center
- Investigators
- Lisa Lancaster, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562247
- Sponsor's protocol ID
- Tenure-1
- Status last verified
- Mar 2023
- First submitted
- 14 Jun 2018
- Last updated
- 16 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telenursing With or Without Remote Monitoring Compared to Usual Care for Patients Newly Diagnosed With Idiopathic Pulmonary Fibrosis.
- ClinicalTrials.gov ID
- NCT03562247
- Acronym / sponsor ID
- Tenure-1
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left the institution and the study was closed with the IRB
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Posted 16 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care of IPF | Active comparator | Other: Usual Care of IPFNewly diagnosed patients will continue to receive excellent healthcare as currently given in management of the lung disease |
| Telenursing | Experimental | Other: Usual Care of IPF, Other: TelenursingPatients 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. |
| Telenursing and Remote Monitoring | Experimental | Other: Usual Care of IPF, Other: Telenursing, Other: Telenursing and Remote MonitoringPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Diagnosed with any other interstitial lung disease.
- Diagnosed and began treatment > 6 months before the VUMC-based diagnosis date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Care of IPFstandard of care given to patients with IPF | Other | Telenursing, Telenursing and Remote Monitoring, Usual Care of IPF |
| Telenursingscheduled phone calls with the patient and care giver | Other | Telenursing, Telenursing and Remote Monitoring |
| Telenursing and Remote Monitoringscheduled phone calls and home monitoring of physiologic parameters | Other | Telenursing and Remote Monitoring |
Primary outcome
The Number Hospitalization Events Resulting From a Respiratory Illness
Time frame: Baseline to 21 months
The number hospitalization events resulting from a respiratory illness
7 secondary outcomes
The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF)
Time frame: Baseline to 21 months
The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)
Time frame: 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 Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: 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 Severity of Anxiety as Measured by the Adapted New Zealand Health Promotion Agency Anxiety Self-Test
Time frame: Baseline to 21 months
The Percentage of Change in Forced Vital Capacity (FVC) Measured by Spirometry
Time frame: Baseline to 21 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Lancaster, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telenursing and Telenursing and Remote Monitoring in people with Idiopathic Pulmonary Fibrosis, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number Hospitalization Events Resulting From a Respiratory Illness (time frame: Baseline to 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.