Persistent Asthma
Conditions
Brief summary
The primary objective is to determine whether continuous sensing, control and mitigation of home indoor air quality influences the frequency of asthma related symptoms, as measured by Serum IgE, Spirometry with exhaled Nitric Oxide, missed school and workdays, need for pharmacologic intervention (albuterol, oral steroids), frequency of sick visits to pulmonologist or primary care provider (PCP), urgent care / emergency department visits, and hospitalizations
Detailed description
Participants will be in the research study for approximately 2 years. There will be 11 visits to the clinic for monitoring of asthma symptoms and pulmonary function and 16 interval contacts with research staff made by either telephone or email to monitor asthma symptoms. There will also be 5 visits to participants' homes by technicians from Emerson Climate Technologies and/or an electrician in cooperation with Emerson. During these visits Emerson employees will assess participants' homes to determine if they qualify for the study and install study equipment to monitor air quality for the first half of the study and monitor and mitigate air quality for the second half of the study. At the end of the study, the technicians and/or electrician from Emerson will reset the study equipment or replace participants' original equipment, if that is their wish. Participants will be enrolled in the research study for approximately 2 years. The first year, technicians from the study sponsor will install indoor air quality monitoring equipment in the participants' homes and information about the air quality in their home as well as baseline health and asthma information will be collected. This will be done through continuous sensing via an Atmocube air quality sensor, and a portable air quality sensor, the Atmotube. Beginning in the second half of the study, mitigation strategies of a smart home thermostat, the Sensi Touch Smart Thermostat, a smart bath fan control, the Enbrighten Z-wave Switch, and high quality furnace filter, 3M Filtrete MPR 2800 Ultrafine Particle Reduction Air Filter, will be employed. Information about the participants' asthma, health status, and air quality in the homes will continue to be collected.
Interventions
DEVICEIndoor Air Quality Mitigation
Mitigation of indoor air quality with use of smart thermostat, smart bath fan control, and high quality furnace filters
Sponsors
Cairify LLC
Copeland LP
Dayton Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
All participants, care providers, and investigators will be blinded to the indoor air quality data as it is collected and the responses of the indoor air quality to mitigation.
Intervention model description
The study will consist of two phases with each participant acting as their own control. Data will be collected from participants and their homes for approximately 1 year without mitigation and compared to a second period of approximately 1 year with mitigation.
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Child aged 5.0-15.9 years at the time of informed consent with mild, moderate, or severe persistent asthma diagnosis. In addition, participants * Agree to attend visits as outlined by protocol * Agree to respond to Asthma Control Test (ACT) and asthma control questions as outlined in protocol by telephone call, text, or email. * Are willing to comply with asthma treatment plan prescribed by physician. * Are willing to practice an acceptable form of birth control to avoid pregnancy. Acceptable forms of birth control include: true abstinence, male or female condom with or without spermicide, female barrier contraception (such as diaphragm, cervical cap, or sponge) with spermicide, continuous use of an intrauterine device throughout the study, hormonal contraceptives (including oral, patch, implanted, or injected), if used consistently and correctly throughout the study. * Reside in single-family dwellings and must either be homeowners or have written permission from their landlords to participate in the study. In order to participate in the study, homes of participants must * have working ducted forced air HVAC systems * a 4-wire thermostat that is determined by Emerson technician to be capable of communicating with Sensi Touch Smart Thermostat * a bathroom fan switch with neutral wire and wall plate, controlling a bathroom fan that is vented to the outdoors * access to the internet with a modem or router. * A smartphone capable of pairing with the Atmotube Pro wearable sensor
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test questionnaire | Through study completion, approximately 2 years | Monthly Asthma Control Test by History. Possible scores ranging from 0 (worst control)-27 (best control) for patients ages 6-11 or 0 (worst control)- 25 (best control) for patients ages 12-16. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of missed school and work days | Through study completion, approximately 2 years | Number of missed school and work days due to asthma symptoms |
| Frequency of asthma Medication Use | Through study completion, approximately 2 years | Use of asthma rescue inhaler and systemic steroids |
| Spirometry with exhaled nitric oxide | Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105 | measurement of Forced Expiratory Volume in 1 second measured quarterly |
| Physical examination | Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105 | head, eyes, ears, nose, throat (HEENT), lungs, cardiovascular, abdominal, neurologic, and musculoskeletal exam by a licensed physician. |
| Mini Paediatric Asthma Quality of Life Questionnaire (MiniPAQLQ) | Weeks 1, 49, 53, 105 | Questionnaire assessing quality of life for patients with asthma. Possible scores range from 13 (worst quality of life)- 91 (best quality of life) |
| Concentration in serum of immunoglobulin E (IgE) | Weeks 1, 53, 105 | blood test measuring IgE |
| Number of asthma related visits to Primary Care Physician, Emergency Department or Urgent Care | Through study completion, approximately 2 years | Sick Visits due to asthma |
| weight | Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105 | weight in kilograms without shoes |
| heart rate | Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105 | heart beats per minute |
| respiratory rate | Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105 | number of breaths per one minute |
| blood pressure | Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105 | systolic over diastolic blood pressure measured in mm/Hg |
| oxygen saturation | Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105 | percent of hemoglobin saturated by oxygen in blood |
| height | Weeks 1, 13, 25, 37, 49, 53, 65, 77, 89, 101, 105 | standing height in centimeters without shoes |
Countries
United States
Outcome results
None listed