RECRUITING

Finding Correlations Between Asthma Exacerbation, Physiological Measurements and Environmental Factors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To identify asthma-related physiological changes observed by wearable devices in real-world conditions by monitor multiple sensing modalities (e.g., heart rate (HR), heart rate variability (HRV), activity level, spirometry, coughing sounds) in order to find reliable signatures of impending asthma exacerbation and systematically explore any challenges on the use of wearable technologies.

Official Title

Finding Correlations Between Asthma Exacerbation, Physiological Measurements and Environmental Factors

Quick Facts

Study Start:2021-09-01

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04845932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Adolescents (14-18 years old) with asthma will be included. * Participants will have to be diagnosed with persistent asthma (as characterized in their UNC health record) that is poorly controlled since this is the focus of the study. They will be identified as eligible for inclusion by the UNC Coordinator partner. However, they should not have any other lung disease other than asthma. They should not be taking any oral steroids every day to control their asthma. They should not need to use their asthma rescue medication multiple times a day to help with their asthma symptoms. They should not have experienced wheezing brought on when performing a lung function test. * Participants should have Wireless Internet access at their homes * Individuals with COVID-19 symptoms will be automatically excluded due to their clinical screening prior to their clinic visit. However, if a participant contracts COVID-19 during the study, they will be encouraged to continue participating since all interactions will be remote after the first clinical screening. * Adolescents should be able to use a iOS device (provided by the researchers) and the devices (with assistance from parents when appropriate) for data collection efforts. They cannot participate in this study if they don't feel comfortable with operating the multiple devices including the iOS device. The iOS device can only be used for the purposes of this study. The iOS device will be restricted by enabling Parental Control Settings accessible only to the researchers. * The participation of an adolescent may be terminated by the investigator if they do not follow the guidelines for the study, including using the devices as instructed or participating in the interviews and weekly surveys. Also, the monthly renewal for the participation of the study (up to 4 months) will be decided by the investigators on a month-by-month basis given that the participant also agrees to continue in the study. * Individuals with physical challenges are allowed to be incidentally included as long as they satisfy all the previous criteria.	* none listed

Inclusion Criteria

Exclusion Criteria

* Adolescents (14-18 years old) with asthma will be included.
* Participants will have to be diagnosed with persistent asthma (as characterized in their UNC health record) that is poorly controlled since this is the focus of the study. They will be identified as eligible for inclusion by the UNC Coordinator partner. However, they should not have any other lung disease other than asthma. They should not be taking any oral steroids every day to control their asthma. They should not need to use their asthma rescue medication multiple times a day to help with their asthma symptoms. They should not have experienced wheezing brought on when performing a lung function test.
* Participants should have Wireless Internet access at their homes
* Individuals with COVID-19 symptoms will be automatically excluded due to their clinical screening prior to their clinic visit. However, if a participant contracts COVID-19 during the study, they will be encouraged to continue participating since all interactions will be remote after the first clinical screening.
* Adolescents should be able to use a iOS device (provided by the researchers) and the devices (with assistance from parents when appropriate) for data collection efforts. They cannot participate in this study if they don't feel comfortable with operating the multiple devices including the iOS device. The iOS device can only be used for the purposes of this study. The iOS device will be restricted by enabling Parental Control Settings accessible only to the researchers.
* The participation of an adolescent may be terminated by the investigator if they do not follow the guidelines for the study, including using the devices as instructed or participating in the interviews and weekly surveys. Also, the monthly renewal for the participation of the study (up to 4 months) will be decided by the investigators on a month-by-month basis given that the participant also agrees to continue in the study.
* Individuals with physical challenges are allowed to be incidentally included as long as they satisfy all the previous criteria.

* none listed

Contacts and Locations

Study Contact

Katie Mills

CONTACT

919-966-2936

katherine.mills@unc.edu

Edgar Lobaton

CONTACT

919-515-5151

edgar.lobaton@ncsu.edu

Study Locations (Sites)

UNC Children's Raleigh Clinic

Raleigh, North Carolina, 27607

United States

Collaborators and Investigators

Sponsor: North Carolina State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-01

Study Completion Date2024-12

Study Record Updates

Study Start Date2021-09-01

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Asthma