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Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From Wearable Devices in Respiratory Diseases

Primary Purpose

Progressive Fibrosing Interstitial Lung Disease, Lung Transplant, Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ADAMM- RSM Device
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Progressive Fibrosing Interstitial Lung Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

    1. Male or female volunteers, at least 18 years of age at the time of screening visit;
    2. Fluent in English and able to follow the instructions to use the ADAMM-RSM™;
    3. Willing and cognitively able to sign informed consent

Exclusion Criteria:

  • Patients must be excluded from participation in this study if any of the following criteria are met:

    1. Pregnancy;
    2. History of active (clinically significant) skin disorders;
    3. History of allergic response to silicones or adhesives;
    4. Subjects with electronic implants of any kind (e.g. pacemaker);
    5. Broken, damaged or irritated skin or rashes near the sensor application sites;
    6. Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device

Arm Description

All participants will wear the device to assist in determining the feasibility of wearing the device.

Outcomes

Primary Outcome Measures

Length of time wearing device (days)
Total length of time participant wears device

Secondary Outcome Measures

Prediction of respiratory exacerbations- Number of emergency room visits
Explore the possibility to predict exacerbations/flares up of the respiratory condition of the patients
Prediction of respiratory exacerbations- Number of hospital admissions
Explore the possibility to predict exacerbations/flares up of the respiratory condition of the patients

Full Information

First Posted
March 25, 2021
Last Updated
April 17, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT04857814
Brief Title
Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From Wearable Devices in Respiratory Diseases
Official Title
Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From ADAMM-RSM in Respiratory Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Fibrosing Interstitial Lung Disease, Lung Transplant, Cystic Fibrosis, Bronchiectasis, Pulmonary Tuberculosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device
Arm Type
Experimental
Arm Description
All participants will wear the device to assist in determining the feasibility of wearing the device.
Intervention Type
Device
Intervention Name(s)
ADAMM- RSM Device
Intervention Description
All participants will wear the ADAMM- RSM device for a 6 month period
Primary Outcome Measure Information:
Title
Length of time wearing device (days)
Description
Total length of time participant wears device
Time Frame
6 month duration per participant
Secondary Outcome Measure Information:
Title
Prediction of respiratory exacerbations- Number of emergency room visits
Description
Explore the possibility to predict exacerbations/flares up of the respiratory condition of the patients
Time Frame
6 month duration per participant
Title
Prediction of respiratory exacerbations- Number of hospital admissions
Description
Explore the possibility to predict exacerbations/flares up of the respiratory condition of the patients
Time Frame
6 month duration per participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Ferrara, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

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Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From Wearable Devices in Respiratory Diseases

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