Progressive Fibrosing Interstitial Lung DiseaseNCT04857814
Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From Wearable Devices in Respiratory Diseases
A study testing ADAMM- RSM Device in people with Progressive Fibrosing Interstitial Lung Disease and Lung Transplant, run by University of Alberta at 1 site in Canada.
Trial summary
Lung diseases are one of the most common causes of emergency room visits. There are very few tools that are able to predict which patients will have a worsening or increasing severity of their condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Fibrosing Interstitial Lung Disease, Lung Transplant, Cystic Fibrosis
- What is being tested?
- ADAMM- RSM Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients with PF-ILD (including IPF), lung transplant, CF, bronchiectasis or TB must meet all of the following criteria to be enrolled in the study:
- Male or female volunteers, at least 18 years of age at the time of screening visit;
- Fluent in English and able to follow the instructions to use the ADAMM-RSM™;
- Willing and cognitively able to sign informed consent
Who cannot join
- Patients must be excluded from participation in this study if any of the following criteria are met:
- Pregnancy;
- History of active (clinically significant) skin disorders;
- History of allergic response to silicones or adhesives;
- Subjects with electronic implants of any kind (e.g. pacemaker);
- Broken, damaged or irritated skin or rashes near the sensor application sites;
- Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From ADAMM-RSM in Respiratory Diseases
Lung diseases are one of the most common causes of emergency room visits. There are very few tools that are able to predict which patients will have a worsening or increasing severity of their condition. There are also limited ways to check the health of patients with respiratory conditions at home and during the time between medical appointments.
The ADAMM-RSMTM device records heart rate, breathing rate, temperature, cough and activity while wearing it. This study will test participants willingness to wear the device and perform ongoing monitoring to assess the possibility to predict the onset and increases in severity of their lung conditions.
Read the detailed description
The project will aim to create the infrastructure to collect clinical data and participants reported biometric measures (ePReBMs) from wearable devices in a database, and to run a pilot phase with a limited number of participants. During this phase, the feasibility of a long-term (6 months) home monitoring of respiratory parameters with the wearable device ADAMM-RSM (Health Care Originals, Rochester, NY, USA) will be tested, in parallel with the standard of care, in a limited number of participants with progressive fibrosing interstitial disease (PF-ILD) including idiopathic pulmonary fibrosis (IPF), lung transplant, cystic fibrosis (CF) and bronchiectasis, and tuberculosis (TB). The study design will test the possibility to collect data from ADAMM-RSM: ideally, the participants should wear the ADAMM-RSM every day, for at least 8 hours. For the purpose of this study, the investigators will aim to collect data from the device for every participant at least 3 days per week, at least 8 hours per day, for a period of 6 months.
The duration of this study is estimated in 2 years, including the data analysis. The participants will be provided the due information about the study and they will sign a written consent before enrolment (a copy is attached to the application to the Research Ethics Office of the University of Alberta).
Every participant enrolled in the study will be asked to wear the ADAMM-RSM (Health Care Originals, Rochester, NY, USA) device every day for 6 months.
The wearable device includes a non-invasive biosensor and processor that is attached to the surface of the skin using an adhesive sticker. It is designed to measure physical activity, heart rate, respiration, skin temperature, and cough metrics using embedded audio transducers, thermistor, accelerometer, gyroscope, and magnetometer. It can be applied anywhere on the chest, with a single-use, changeable sticker. As such, the device is able to collect heart and respiratory rate, temperature and cough, and to correlate these parameters to rest, activity and intensity of activity for the duration of the battery (18 hours). After signing the informed consent, the participants will be instructed on how to apply and to remove the device on/from the chest, to use the device during the day, and to recharge it at night using its dedicated charger.
Every device is supplied with a unique anonymous identifier, and will transmit the data via Wi-Fi to a cloud secured database provided by Health Care Originals (Health Care Originals, Rochester, NY, USA). This database will be physically located in a server within the Canadian borders. The database will be moved to a secured server at the University of Alberta at the end of the study.
Potential registrations of speech during cough episodes are prevented by an integrated algorithm in the device, cleaning automatically any sound other than cough before transferring the data to the cloud server.
Local research coordinators will use a web-based portal to check the usage of the devices and that the devices are working properly. This portal does not include personal data of the participants but only the device identifier so matching back of actual patient to data stream will not occur on any of Healthcare Originals infrastructure.
A unique progressive study ID will be assigned to every participant entering the study. This ID will be coupled to the ADAMM-RSM identifier and it will be used in a separate database to collect clinical and follow-up data. The ID will be coupled to participants identifiers only in a third excel file, encrypted and protected with a password that will be accessible only to the study investigators.
The participants will be requested to fill 3 quality of life questionnaires (the King's Brief Interstitial Lung Disease questionnaire for PF-ILD or Saint George Respiratory Questionnaire for the other diagnoses, the Leicester Cough Questionnaire and the MRC dyspnea questionnaire for all the enrolled patients) at the time of enrolment, and after 3 and 6 months. The questionnaires will be used to compare responses at 3 and 6 months to the data generated from the device. Participants will be asked to return the device to the study site at the 6-month timepoint. Clinical data will be collected from the participant's chart if available at the baseline, 3, and 6 month timepoints as per the CRF's.
- Conditions
- Progressive Fibrosing Interstitial Lung Disease, Lung Transplant, Cystic Fibrosis, Bronchiectasis, Pulmonary Tuberculosis
- Being tested
- ADAMM- RSM Device
- Medical subject headings
- Cystic Fibrosis, Bronchiectasis, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAMM- RSM DeviceDevice
All participants will wear the ADAMM- RSM device for a 6 month period
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | All participants will wear the device to assist in determining the feasibility of wearing the device. Receives: Device: ADAMM- RSM Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time wearing device (days)
Total length of time participant wears device
Measured: 6 month duration per participant
Secondary outcomes (2)
Prediction of respiratory exacerbations- Number of emergency room visits
Explore the possibility to predict exacerbations/flares up of the respiratory condition of the patients
Measured: 6 month duration per participant
Prediction of respiratory exacerbations- Number of hospital admissions
Explore the possibility to predict exacerbations/flares up of the respiratory condition of the patients
Measured: 6 month duration per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Jul 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Fibrosing Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Ferrara, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857814
- Sponsor's protocol ID
- Pro00097162
- Status last verified
- Apr 2023
- First submitted
- 25 Mar 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From ADAMM-RSM in Respiratory Diseases
- ClinicalTrials.gov ID
- NCT04857814
- Acronym / sponsor ID
- Pro00097162
- Conditions
- Progressive Fibrosing Interstitial Lung Disease, Lung Transplant, Cystic Fibrosis, Bronchiectasis, Pulmonary Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung diseases are one of the most common causes of emergency room visits. There are very few tools that are able to predict which patients will have a worsening or increasing severity of their condition. There are also limited ways to check the health of patients with respiratory conditions at home and during the time between medical appointments.
The ADAMM-RSMTM device records heart rate, breathing rate, temperature, cough and activity while wearing it. This study will test participants willingness to wear the device and perform ongoing monitoring to assess the possibility to predict the onset and increases in severity of their lung conditions.
Detailed description
The project will aim to create the infrastructure to collect clinical data and participants reported biometric measures (ePReBMs) from wearable devices in a database, and to run a pilot phase with a limited number of participants. During this phase, the feasibility of a long-term (6 months) home monitoring of respiratory parameters with the wearable device ADAMM-RSM (Health Care Originals, Rochester, NY, USA) will be tested, in parallel with the standard of care, in a limited number of participants with progressive fibrosing interstitial disease (PF-ILD) including idiopathic pulmonary fibrosis (IPF), lung transplant, cystic fibrosis (CF) and bronchiectasis, and tuberculosis (TB). The study design will test the possibility to collect data from ADAMM-RSM: ideally, the participants should wear the ADAMM-RSM every day, for at least 8 hours. For the purpose of this study, the investigators will aim to collect data from the device for every participant at least 3 days per week, at least 8 hours per day, for a period of 6 months.
The duration of this study is estimated in 2 years, including the data analysis. The participants will be provided the due information about the study and they will sign a written consent before enrolment (a copy is attached to the application to the Research Ethics Office of the University of Alberta).
Every participant enrolled in the study will be asked to wear the ADAMM-RSM (Health Care Originals, Rochester, NY, USA) device every day for 6 months.
The wearable device includes a non-invasive biosensor and processor that is attached to the surface of the skin using an adhesive sticker. It is designed to measure physical activity, heart rate, respiration, skin temperature, and cough metrics using embedded audio transducers, thermistor, accelerometer, gyroscope, and magnetometer. It can be applied anywhere on the chest, with a single-use, changeable sticker. As such, the device is able to collect heart and respiratory rate, temperature and cough, and to correlate these parameters to rest, activity and intensity of activity for the duration of the battery (18 hours). After signing the informed consent, the participants will be instructed on how to apply and to remove the device on/from the chest, to use the device during the day, and to recharge it at night using its dedicated charger.
Every device is supplied with a unique anonymous identifier, and will transmit the data via Wi-Fi to a cloud secured database provided by Health Care Originals (Health Care Originals, Rochester, NY, USA). This database will be physically located in a server within the Canadian borders. The database will be moved to a secured server at the University of Alberta at the end of the study.
Potential registrations of speech during cough episodes are prevented by an integrated algorithm in the device, cleaning automatically any sound other than cough before transferring the data to the cloud server.
Local research coordinators will use a web-based portal to check the usage of the devices and that the devices are working properly. This portal does not include personal data of the participants but only the device identifier so matching back of actual patient to data stream will not occur on any of Healthcare Originals infrastructure.
A unique progressive study ID will be assigned to every participant entering the study. This ID will be coupled to the ADAMM-RSM identifier and it will be used in a separate database to collect clinical and follow-up data. The ID will be coupled to participants identifiers only in a third excel file, encrypted and protected with a password that will be accessible only to the study investigators.
The participants will be requested to fill 3 quality of life questionnaires (the King's Brief Interstitial Lung Disease questionnaire for PF-ILD or Saint George Respiratory Questionnaire for the other diagnoses, the Leicester Cough Questionnaire and the MRC dyspnea questionnaire for all the enrolled patients) at the time of enrolment, and after 3 and 6 months. The questionnaires will be used to compare responses at 3 and 6 months to the data generated from the device. Participants will be asked to return the device to the study site at the 6-month timepoint. Clinical data will be collected from the participant's chart if available at the baseline, 3, and 6 month timepoints as per the CRF's.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: ADAMM- RSM DeviceAll participants will wear the device to assist in determining the feasibility of wearing the device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with PF-ILD (including IPF), lung transplant, CF, bronchiectasis or TB must meet all of the following criteria to be enrolled in the study:
Key exclusion criteria (7 listed)
- Patients must be excluded from participation in this study if any of the following criteria are met:
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 |
|---|---|---|
| ADAMM- RSM DeviceAll participants will wear the ADAMM- RSM device for a 6 month period | Device | Device |
Primary outcome
Length of time wearing device (days)
Time frame: 6 month duration per participant
Total length of time participant wears device
2 secondary outcomes
Prediction of respiratory exacerbations- Number of emergency room visits
Time frame: 6 month duration per participant
Prediction of respiratory exacerbations- Number of hospital admissions
Time frame: 6 month duration per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
Related trials for Progressive Fibrosing Interstitial Lung Disease
RecruitingPhase 2
A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients
Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)
Active, not recruitingPhase 2
A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)
Idiopathic Pulmonary Fibrosis, Progressive Fibrosing Interstitial Lung Disease
Active, not recruitingObservational study
Hyperpolarized 129-Xenon MRI in Fibrosing Interstitial Lung Disease
Progressive Fibrosing Interstitial Lung Disease
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.
Giovanni Ferrara, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADAMM- RSM Device in people with Progressive Fibrosing Interstitial Lung Disease and Lung Transplant, run by University of Alberta at 1 site in Canada.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 19 Apr 2023. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of time wearing device (days) (time frame: 6 month duration per participant). 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 19 Apr 2023.