Trial Outcomes & Findings for Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT03562247)

NCT ID: NCT03562247

Last Updated: 2024-01-16

Results Overview

The number hospitalization events resulting from a respiratory illness

Recruitment status

TERMINATED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

Baseline to 21 months

Results posted on

2024-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	10	11	10
Overall Study COMPLETED	7	10	9
Overall Study NOT COMPLETED	3	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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
Overall Study Lost to Follow-up	3	1	1

Baseline Characteristics

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.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline to 21 months

The number hospitalization events resulting from a respiratory illness

Outcome measures

Outcome measures
Measure	Usual Care of Idiopathic Pulmonary Fibrosis (IPF) n=7 Participants 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	Telenursing n=10 Participants 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	Telenursing and Remote Monitoring n=9 Participants 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
The Number Hospitalization Events Resulting From a Respiratory Illness	1 Events	0 Events	0 Events

SECONDARY outcome

Timeframe: 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.

The number of respiratory events that indicate a worsening of Idiopathic Pulmonary Fibrosis (IPF)

Outcome measures

Outcome measures
Measure	Usual Care of Idiopathic Pulmonary Fibrosis (IPF) n=7 Participants 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	Telenursing n=7 Participants 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	Telenursing and Remote Monitoring n=9 Participants 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
The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) 4 percentage points decline in home saturation	0 Events	0 Events	0 Events
The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) respiratory infection	0 Events	0 Events	1 Events
The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) pneumonia	0 Events	0 Events	0 Events
The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) pneumothorax	0 Events	0 Events	0 Events
The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) pleural effusion	0 Events	0 Events	0 Events
The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) pulmonary embolus	1 Events	0 Events	0 Events
The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) >= 5% decline in clinic FVC (from last visit)	3 Events	0 Events	1 Events
The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) >= 10% decline in clinic FVC (from last visit)	2 Events	0 Events	1 Events
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	0 Events	0 Events
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	1 Events	0 Events
The Number of Respiratory Events That Indicate a Worsening of Idiopathic Pulmonary Fibrosis (IPF) 5% decline in home FVC	0 Events	0 Events	0 Events

SECONDARY outcome

Timeframe: Baseline to 21 months

The Number of Acute Exacerbations of IPF

Outcome measures

Outcome measures
Measure	Usual Care of Idiopathic Pulmonary Fibrosis (IPF) n=7 Participants 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	Telenursing n=10 Participants 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	Telenursing and Remote Monitoring n=9 Participants 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
The Number of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)	0 number of events	0 number of events	0 number of events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care of Idiopathic Pulmonary Fibrosis (IPF) n=7 Participants 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	Telenursing n=10 Participants 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	Telenursing and Remote Monitoring n=9 Participants 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
The Number of Days From Idiopathic Pulmonary Fibrosis (IPF) Diagnosis to First Hospitalization for Respiratory Illness	367 days	NA days There were no hospitalization events for respiratory illness reported in the Telenursing Arm. As a result, data entry for this field is NA (not applicable).	NA days There were no hospitalization events for respiratory illness reported in the Telenursing and Remote Monitoring Arm. As a result, data entry for this field is NA (not applicable).

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Usual Care of Idiopathic Pulmonary Fibrosis (IPF) n=7 Participants 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	Telenursing n=10 Participants 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	Telenursing and Remote Monitoring n=8 Participants 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
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	1 score on a scale Standard Deviation 1.09	—
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 0.70	0.66 score on a scale Standard Deviation 0.57	1.5 score on a scale Standard Deviation 1.29
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	2 score on a scale Standard Deviation 0	0.33 score on a scale Standard Deviation 0.57
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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care of Idiopathic Pulmonary Fibrosis (IPF) n=7 Participants 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	Telenursing n=10 Participants 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	Telenursing and Remote Monitoring n=9 Participants 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
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	5.7 score on a scale Standard Deviation 4.62	4.38 score on a scale Standard Deviation 5.12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care of Idiopathic Pulmonary Fibrosis (IPF) n=7 Participants 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	Telenursing n=10 Participants 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	Telenursing and Remote Monitoring n=9 Participants 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
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	3.55 score on a scale Standard Deviation 3.32	5.61 score on a scale Standard Deviation 7.25

SECONDARY outcome

Timeframe: 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.

The percentage of change in home-measured forced vital capacity (FVC) compared to clinic-measured FVC via spirometry

Outcome measures

Outcome data not reported

Adverse Events

Usual Care of Idiopathic Pulmonary Fibrosis (IPF)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Telenursing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Telenursing and Remote Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Usual Care of Idiopathic Pulmonary Fibrosis (IPF) n=7 participants at risk 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	Telenursing n=10 participants at risk 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	Telenursing and Remote Monitoring n=9 participants at risk 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
Respiratory, thoracic and mediastinal disorders Pulmonary embolus	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/10 • 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.	0.00% 0/9 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Lisa Lancaster, MD

Vanderbilt University Medical Center

Phone: 615-322-2386

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place