Using Data From a Multisensor Rapid Health Assessment Device to Predict Decompensation in Long CO… (NCT05713266) | Clinical Trial Compass
CompletedNot Applicable
Using Data From a Multisensor Rapid Health Assessment Device to Predict Decompensation in Long COVID (AIDI)
United States204 participantsStarted 2022-10-31
Plain-language summary
We are conducting a research study at the VA hospital in Bedford, MA to learn more about how a multisensor rapid health assessment device, MouthLab, can help predict or anticipate future health complications in patients with underline conditions after contracting COVID-19. The device was created by a health technology and digital medicine company called Aidar Health, Inc. MouthLab is a non-invasive, hand-held device that works like a breathalyzer. An individual breathes into the device for 60 seconds and the MouthLab gathers more than 10 vital health parameters like temperature, heart rate, SpO2, ECG, and basic lung functions. Participation in the study will last for 6 months, and the purpose is to gather health information from people who have been previously hospitalized with COVID-19. We will use the data to develop an algorithm that predicts future complications of COVID-19, especially among patients with complex conditions (i.e., heart failure, chronic kidney disease, diabetes, hypertension, asthma, chronic obstructive pulmonary disease), and enables early intervention.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age or older
* Individuals who have had a COVID-19 related hospitalization (3-6 months prior to enrollment)
* Has at least one specified comorbidity (Diabetes, Heart Failure, Hypertension, Chronic Kidney Disease, Asthma, or COPD)
* Willing and able to provide informed consent
* Has no functional limitation that would impede the use of the MouthLab device, and is able to use the device with the left hand
* Comfortable with using technology
* Can commit to performing the required study tasks
* Can speak/understand English
Exclusion Criteria:
* Currently receiving hospice care
* Left-sided hemiplegia or any other motor deficits that may restrict the use of the device.
* Individuals with cognitive deficits that impede their ability to comprehend and give informed consent.
* Chest, abdominal or eye surgery within the preceding 14 days
* Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All cause higher level of care utilization
Timeframe: 6 months
Trial details
NCT IDNCT05713266
SponsorEdith Nourse Rogers Memorial Veterans Hospital