NO 0050-0637

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

ICON Early Phase Services is conducting a non-interventional device research study adults age 40+ who are either healthy, or, have chronic obstructive pulmonary disease (COPD). This study is being done to test the potential of using devices to help manage disease symptoms.

Participants will complete a screening visit to determine eligibility.

Participants will complete:

  • 1 screening visit
  • 1 training visit   *same day as screening visit
  • 15 days on-study collecting data
  • 1 exit interview by phone

 

Description

Qualified participants may be compensated up to $1,350 for time and travel. For more details, please visit our study website at

Details
Condition COPD (Chronic Obstructive Pulmonary Disease)
Clinical Study IdentifierTX240339
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 40 yrs?
Gender: Male or Female
Do you have COPD (Chronic Obstructive Pulmonary Disease)?
If you are able to answer “YES” to the following statements, you may qualify for this study
I am a healthy adult, meaning no significant medical conditions. NOTE: WE ARE DONE WITH THE HEALTHY PORTION OF THIS STUDY
-OR--
I have chronic obstructive pulmonary disease/COPD (self-reported)
I am at least 40 years old or older
I am able to read speak and understand English fluently
I am willing to wear an activity tracker on my wrist over a 15-day period and charge this device as needed
I am willing to wear data transfer patches over 15 days and charge the units regularly
I am willing to record night time cough for 15 days
I am willing to keep the hotspot powered on and charging
I am willing to complete questionnaires throughout the study
I own/have access to a smartphone or tablet to use in this study
I have Wi-Fi or mobile data connectivity to enable the study app to be downloaded and sufficient storage space to download the app
I am able to download an application to my personal device (smartphone or tablet)
I have an Android (version 4.4 or higher) or iOS (version 10 and 11)
I have an active and accessible app store (Android or Apple) associated with my device to enable app download
It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures. Scheduling a screening appointment does not guarantee that you will qualify for that study
Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit. No guarantees can be made regarding group assignments for any particular study. ICON will not assume any liability for lost time, travel or failure to qualify
Please note, you need to bring a valid, non-expired photo ID with you when you attend your screening visit. We accept a government issued identification card such as a driver's license, state issued ID card, military ID or passport. You will be required to show this same photo ID at all study visits
You will be filling out paperwork for the study. Please arrive at least 30 minutes in advance of your screening appointment. If you are late for your appointment you may not be seen or may need to reschedule
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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