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

NCT04857814 | Completed

• 1 other identifier: Pro00097162
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Fibrosing Interstitial Lung Disease; Lung Transplant; Cystic Fibrosis; Bronchiectasis; Pulmonary Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Length of time wearing device (days)

  Total length of time participant wears device

  6 month duration per participant

Secondary Outcomes (2)

• Prediction of respiratory exacerbations- Number of emergency room visits

  6 month duration per participant

• Prediction of respiratory exacerbations- Number of hospital admissions

  6 month duration per participant

Study Arms (1)

Device

EXPERIMENTAL

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

Device: ADAMM- RSM Device

Interventions

ADAMM- RSM Device DEVICE

All participants will wear the ADAMM- RSM device for a 6 month period

Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis; Bronchiectasis; Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bronchial Diseases; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections

Study Officials

• Giovanni Ferrara, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 23, 2021
• Study Start: July 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

CA (1)