Idiopathic Pulmonary Fibrosis
Conditions
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.
Interventions
OTHERUsual Care of IPF
standard of care given to patients with IPF
OTHERTelenursing
scheduled phone calls with the patient and care giver
OTHERTelenursing and Remote Monitoring
scheduled phone calls and home monitoring of physiologic parameters
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number Hospitalization Events Resulting From a Respiratory Illness | Baseline to 21 months | The number hospitalization events resulting from a respiratory illness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) | Baseline to 21 months | The Number of Acute Exacerbations of IPF |
| The Number of Days From Idiopathic Pulmonary Fibrosis (IPF) Diagnosis to First Hospitalization for Respiratory Illness | Baseline to 21 months | 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. |
| The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale | Baseline to 21 months | 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). |
| The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | Baseline to 21 months | The number of respiratory events that indicate a worsening of Idiopathic Pulmonary Fibrosis (IPF) |
| The Severity of Anxiety as Measured by the Adapted New Zealand Health Promotion Agency Anxiety Self-Test | Baseline to 21 months | 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. |
| The Percentage of Change in Forced Vital Capacity (FVC) Measured by Spirometry | Baseline to 21 months | The percentage of change in home-measured forced vital capacity (FVC) compared to clinic-measured FVC via spirometry |
| The Severity of Depression as Measured by the Adapted Mental Health America Depression Screening Tool | Up to 21 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) Newly diagnosed patients will continue to receive standard of care in management of Idiopathic Pulmonary Fibrosis (IPF)
Usual Care of IPF: Standard of care given to patients with IPF | 10 |
| Telenursing Patients will receive usual care with structured phone calls from the nurse practitioner and/or case manager occurring 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.
Usual Care of IPF: Standard of care given to patients with IPF
Telenursing: Scheduled phone calls with the patient and care giver | 11 |
| 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.
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 | 10 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 | 1 |
Baseline characteristics
| Characteristic | Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | Telenursing | Telenursing and Remote Monitoring | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 5 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 7 Participants | 8 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 7 Participants | 6 Participants | 8 Participants | 21 Participants |
| Region of Enrollment United States | 10 Participants | 11 Participants | 10 Participants | 31 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 0 / 7 | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 1 / 7 | 0 / 10 | 0 / 9 |
Outcome results
Primary
The Number Hospitalization Events Resulting From a Respiratory Illness
The number hospitalization events resulting from a respiratory illness
Time frame: Baseline to 21 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number Hospitalization Events Resulting From a Respiratory Illness | 1 Events |
| Telenursing | The Number Hospitalization Events Resulting From a Respiratory Illness | 0 Events |
| Telenursing and Remote Monitoring | The Number Hospitalization Events Resulting From a Respiratory Illness | 0 Events |
Secondary
The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)
The Number of Acute Exacerbations of IPF
Time frame: Baseline to 21 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) | 0 number of events |
| Telenursing | The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) | 0 number of events |
| Telenursing and Remote Monitoring | The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) | 0 number of events |
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.
Time frame: Baseline to 21 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Days From Idiopathic Pulmonary Fibrosis (IPF) Diagnosis to First Hospitalization for Respiratory Illness | 367 days |
| Telenursing | The Number of Days From Idiopathic Pulmonary Fibrosis (IPF) Diagnosis to First Hospitalization for Respiratory Illness | NA days |
| Telenursing and Remote Monitoring | The Number of Days From Idiopathic Pulmonary Fibrosis (IPF) Diagnosis to First Hospitalization for Respiratory Illness | NA days |
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)
Time frame: Baseline to 21 months
Population: Incomplete data was collected due to non-standardized practices (e.g., no standard processes in place for how data was collected, formatted, or reported). Data was not collected for 3 participants in the Telenursing arm: Exhaustive efforts were made to obtain the missing data, but the original PI has left and it is nonexistent in the EDC and cannot be located elsewhere.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | >= 5% decline in clinic FVC (from last visit) | 3 Events |
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | >= 10% decline in clinic FVC (from last visit) | 2 Events |
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | 5% decline in home FVC | 0 Events |
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | >= 5% decline in clinic FVC (from one year ago) | 1 Events |
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | >= 10% decline in clinic FVC (from one year ago) | 4 Events |
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | pneumonia | 0 Events |
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | 4 percentage points decline in home saturation | 0 Events |
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | pneumothorax | 0 Events |
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | pleural effusion | 0 Events |
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | pulmonary embolus | 1 Events |
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | respiratory infection | 0 Events |
| Telenursing | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | pneumonia | 0 Events |
| Telenursing | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | >= 5% decline in clinic FVC (from last visit) | 0 Events |
| Telenursing | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | respiratory infection | 0 Events |
| Telenursing | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | pleural effusion | 0 Events |
| Telenursing | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | >= 10% decline in clinic FVC (from last visit) | 0 Events |
| Telenursing | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | 5% decline in home FVC | 0 Events |
| Telenursing | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | pneumothorax | 0 Events |
| Telenursing | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | >= 5% decline in clinic FVC (from one year ago) | 0 Events |
| Telenursing | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | 4 percentage points decline in home saturation | 0 Events |
| Telenursing | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | >= 10% decline in clinic FVC (from one year ago) | 1 Events |
| Telenursing | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | pulmonary embolus | 0 Events |
| Telenursing and Remote Monitoring | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | >= 10% decline in clinic FVC (from one year ago) | 0 Events |
| Telenursing and Remote Monitoring | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | 5% decline in home FVC | 0 Events |
| Telenursing and Remote Monitoring | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | 4 percentage points decline in home saturation | 0 Events |
| Telenursing and Remote Monitoring | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | respiratory infection | 1 Events |
| Telenursing and Remote Monitoring | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | pneumonia | 0 Events |
| Telenursing and Remote Monitoring | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | pneumothorax | 0 Events |
| Telenursing and Remote Monitoring | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | pleural effusion | 0 Events |
| Telenursing and Remote Monitoring | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | pulmonary embolus | 0 Events |
| Telenursing and Remote Monitoring | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | >= 5% decline in clinic FVC (from last visit) | 1 Events |
| Telenursing and Remote Monitoring | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | >= 10% decline in clinic FVC (from last visit) | 1 Events |
| Telenursing and Remote Monitoring | The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) | >= 5% decline in clinic FVC (from one year ago) | 0 Events |
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
Time frame: Baseline to 21 months
Population: Incomplete data was collected due to non-standardized practices (e.g., no standard processes in place for how data was collected, formatted, or reported). Data not collected includes: Usual Care: Missing data from 7 participants / Telenursing: Missing data from 10 participants / Telenursing and Remote Monitoring: Missing data from 9 participants. Exhaustive efforts were made to obtain the missing data, but the original PI has left and it is nonexistent in the EDC and cannot be located elsewhere.
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.
Time frame: Baseline to 21 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Severity of Anxiety as Measured by the Adapted New Zealand Health Promotion Agency Anxiety Self-Test | 5.0 score on a scale | Standard Deviation 6.88 |
| Telenursing | The Severity of Anxiety as Measured by the Adapted New Zealand Health Promotion Agency Anxiety Self-Test | 3.55 score on a scale | Standard Deviation 3.32 |
| Telenursing and Remote Monitoring | The Severity of Anxiety as Measured by the Adapted New Zealand Health Promotion Agency Anxiety Self-Test | 5.61 score on a scale | Standard Deviation 7.25 |
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.
Time frame: Up to 21 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Severity of Depression as Measured by the Adapted Mental Health America Depression Screening Tool | 4.75 score on a scale | Standard Deviation 4.98 |
| Telenursing | The Severity of Depression as Measured by the Adapted Mental Health America Depression Screening Tool | 5.7 score on a scale | Standard Deviation 4.62 |
| Telenursing and Remote Monitoring | The Severity of Depression as Measured by the Adapted Mental Health America Depression Screening Tool | 4.38 score on a scale | Standard Deviation 5.12 |
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).
Time frame: Baseline to 21 months
Population: Incomplete data was collected due to non-standardized practices (e.g., no standard processes in place for how data was collected, formatted, or reported). Data was not collected for this outcome measure for 1 participant in the Telenursing and Remote Monitoring arm. Exhaustive efforts were made to obtain the missing data, but the original PI has left and it is nonexistent in the EDC and cannot be located elsewhere.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale | Visit 2 (3 months) | 1.5 score on a scale | Standard Deviation 0.7 |
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale | Baseline | 1.5 score on a scale | Standard Deviation 0.57 |
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale | Visit 3 (9 months) | 3 score on a scale | Standard Deviation 1.41 |
| Telenursing | The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale | Visit 3 (9 months) | 2 score on a scale | Standard Deviation 0 |
| Telenursing | The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale | Baseline | 1 score on a scale | Standard Deviation 1.09 |
| Telenursing | The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale | Visit 2 (3 months) | 0.66 score on a scale | Standard Deviation 0.57 |
| Telenursing and Remote Monitoring | The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale | Visit 5 (21 months) | 0 score on a scale | Standard Deviation 0 |
| Telenursing and Remote Monitoring | The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale | Visit 2 (3 months) | 1.5 score on a scale | Standard Deviation 1.29 |
| Telenursing and Remote Monitoring | The Severity of Dyspnea as Measured by the Modified Medical Research Council (mMRC) Dyspnea Scale | Visit 3 (9 months) | 0.33 score on a scale | Standard Deviation 0.57 |