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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up active arm only: baseline and months 1, 2, 3, 4, 5, 6, 8, 10, 12
Awards & highlights
ADS Trial Summary
This trial will investigate the impact of digital tools on asthma symptoms, exacerbations, healthcare utilization, and costs in adults with asthma.
ADS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ active arm only: baseline and months 1, 2, 3, 4, 5, 6, 8, 10, 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~active arm only: baseline and months 1, 2, 3, 4, 5, 6, 8, 10, 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in asthma-associated expenditures due to emergency department and hospital utilization
Secondary outcome measures
Adherence to Refills and Medications Scale, 7-item version (ARMS-7)
Adherence to asthma medications
Asthma Medication Ratio
+13 moreADS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ActiveExperimental Treatment1 Intervention
Active arm participants will be sent the same devices, also at no cost, and asked to use them in the same manner.
Only the active arm will have access to Study App features for asthma self-management, including:
"Smart nudges" that may promote proactive asthma self-management
Asthma symptom and trigger tracking
Evidence-based asthma education
The ability to photograph and easily reference an asthma action plan from a healthcare provider.
A 90-day summary of self-reported asthma symptoms/triggers and device-recorded heart rate and respiratory rate. This summary can be shared with providers.
In-app viewing of active asthma medications, refills available, and phone numbers to call for refills (subject to prescription benefits).
Active participants can, but are not required to, use the Study App in Year 2. Those who choose to may keep using study devices in Year 2, provided they meet requirements to keep devices. These requirements are the same for both arms.
Group II: PassiveActive Control1 Intervention
Passive arm participants will be sent two devices, at no cost-an Apple Watch and a Beddit Sleep Monitor. These are commercially available and have not been modified for this study. Participants will be asked to use these devices regularly throughout study Year 1. Participants can optionally continue to use devices during Year 2, if they have met requirements during Year 1 to keep study devices. To be eligible to keep devices, participants must meet pre-specified levels of adherence to study procedures.
Access to the Study App will be provided to all participants. It will be used to administer informed consent and electronic patient reported outcome (ePRO) measures, and for other study purposes. However, passive participants will not have access to the Study App features designed to support asthma self-management.
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Who is running the clinical trial?
Elevance HealthLead Sponsor
1 Previous Clinical Trials
14,442 Total Patients Enrolled
HealthCore, Inc.Industry Sponsor
14 Previous Clinical Trials
7,793,763 Total Patients Enrolled
CareEvolution, LLCUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking any medication for asthma that affects your immune system.You have been diagnosed with chronic sinusitis, pharyngitis, influenza, allergic rhinitis, hypertension, diabetes, or obesity.You are unable to consistently sleep in a bed with a Beddit sleep monitor at least 5 nights per week. This includes people with irregular sleep schedules or those who frequently travel and cannot consistently sleep on the sensor.You have a history of smoking cigarettes.You have been diagnosed with any of the following conditions: Chronic Obstructive Pulmonary Disease/Emphysema, Cystic Fibrosis, any type of cancer except non-melanoma skin cancer, dementia, neurodegenerative diseases like Parkinson's, schizophrenia, heart failure, undergoing dialysis, or you are a woman who gave birth within the past 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Passive
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who might be a good candidate for this type of research?
"This study requires 901 participants that suffer from asthma and are aged between 18-64. Most importantly, applicants must meet the following conditions: Own an iPhone 6s or later, Have been diagnosed with chronic sinusitis, pharyngitis, influenza, allergic rhinitis, hypertension, diabetes, and/or obesity by a medical professional, Be of legal smoking age in their country."
Answered by AI
Are there any patients currently enrolled in this experiment?
"Unfortunately, this study is not enrolling new patients at the moment. According to clinicaltrials.gov, the last update for this trial was on December 29th 2021 and it was originally posted on October 30th 2020. However, there are 327 other trials that are still seeking participants."
Answered by AI
Are adolescents eligible for this kind of medical research?
"The age requirements to participate in this clinical trial are that you must be between 18-64 years old."
Answered by AI
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