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Principal Investigator left the institution and the study was closed with the IRB
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care of IPF | Active Comparator | Newly diagnosed patients will continue to receive excellent healthcare as currently given in management of the lung disease |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care of IPF | Other | standard of care given to patients with IPF |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number Hospitalization Events Resulting From a Respiratory Illness | The number hospitalization events resulting from a respiratory illness | Baseline to 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline to 21 months |
| The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Lancaster, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Telenursing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 4 participants / Telenursing: Missing data from 4 participants / Telenursing and Remote Monitoring: Missing data from 2 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number Hospitalization Events Resulting From a Respiratory Illness | The number hospitalization events resulting from a respiratory illness | Posted | Number | Events | Baseline to 21 months |
|
Baseline to 21 months
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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This study was terminated early due to the original PI leaving the institution. The new PI never enrolled any participants and the study was closed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Lancaster, MD | Vanderbilt University Medical Center | 615-322-2386 | lisa.lancaster@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2018 | Feb 12, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2020 | Feb 12, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D055817 | Telenursing |
| ID | Term |
|---|---|
| D009729 | Nursing |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Telenursing | Other | scheduled phone calls with the patient and care giver |
|
| Telenursing and Remote Monitoring | Other | scheduled phone calls and home monitoring of physiologic parameters |
|
The Number of Acute Exacerbations of IPF |
| 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. | 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). | 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. | 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. | 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 | Baseline to 21 months |
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 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 3 participants / Telenursing: Missing data from 4 participants / Telenursing and Remote Monitoring: Missing data from 2 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. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 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 3 participants / Telenursing: Missing data from 1 participant / Telenursing and Remote Monitoring: Missing data from 1 participant. 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. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 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 3 participants / Telenursing: Missing data from 1 participant / Telenursing and Remote Monitoring: Missing data from 1 participant. 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. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 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 |
|
|
| 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) | 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. | Posted | Number | Events | Baseline to 21 months |
|
|
|
| Secondary | The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) | The Number of Acute Exacerbations of IPF | Posted | Number | number of events | Baseline to 21 months |
|
|
|
| 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. | Posted | Number | days | Baseline to 21 months |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 21 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 21 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 21 months |
|
|
|
| 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 | 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. | Posted | Baseline to 21 months |
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| 0 |
| 7 |
| EG001 | 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 | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | 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 | 0 | 9 | 0 | 9 | 0 | 9 |
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| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| respiratory infection |
|
| pneumonia |
|
| pneumothorax |
|
| pleural effusion |
|
| pulmonary embolus |
|
| >= 5% decline in clinic FVC (from last visit) |
|
| >= 10% decline in clinic FVC (from last visit) |
|
| >= 5% decline in clinic FVC (from one year ago) |
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| >= 10% decline in clinic FVC (from one year ago) |
|
| Visit 2 (3 months) |
|
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| Visit 3 (9 months) |
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| Visit 4 (15 months) |
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| Visit 5 (21 months) |
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|