The Fox Intel Mobile Application Trial (The FIAT Study)

Assessment of the Feasibility of mobile phone application and wearable sensors for individuals with PD

Recruitment Information:

Accepts Control Volunteers: No Study Type: Observational
Eligible Ages: 30 - 100 Status: Completed
Time Since Diagnosis: Less than 60 years Study Focus:
Diagnosis Accepted: PD

Study Purpose:

Wearable technologies, such as smartphones and smartwatches, are revolutionary tools for Parkinson’s research that can capture objective clinical data like activity level and sleep analysis. This study is sponsored by The Michael J. Fox Foundation (MJFF) and needs volunteers to help test and validate how two specific devices (the Pebble Watch and an Android smartphone) in addition to the Fox Intel App (FIA) can be used to capture Parkinson’s-related data. The study, taking place in New York City, needs 20 volunteers who have Parkinson’s and live in the area. Participation will include wearing two devices provided by the study for up to 30 days in addition to one to two visits to the MJFF office in Manhattan. Volunteers will also be asked to join weekly calls with the study team to provide feedback. Validating wearable devices for Parkinson’s research will open the door to better tracking and understanding of the disease. To learn more and get in touch with a study coordinator, call or email Cornelia Kamp at 585-355-5341 or ckamp@clintrex.com.

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More Details

A total of ~20 participants will be included in this study. Patients already registered on Fox Trial Finder that reside in the New York City metropolitan area (phase 1 only) will be solicited about possible participation. Those subjects that consent to participate will complete an Enrollment Completion Form to confirm entry criteria. Those participants that are determined to be eligible will be contacted by Clintrex, (the group running the study on behalf of The Michael J. Fox Foundation) with next steps depending on which phase of the study the subject is participating in. The study will be conducted in two phases: Phase 1: The first 10 participants enrolled will attend an in-person device instruction/training meeting at The Michael J. Fox Foundation’s office in Manhattan. During this meeting, the subjects will be given a Fox Intel App (FIA) kit and full verbal instructions and demonstration on the use of the device (e.g. how to put the device on, how to turn it on/off, how to charge it etc.), along with an instruction manual for how to use the device. The participants will then be asked to wear the sensors for 1 month and will be provided with written instructions regarding on the device and how to complete the required information. Data collection for each participant will subsequently be conducted entirely via the Internet. Participants will be called weekly to determine if there are any device issues. At the completion of the study, participants will be asked to participate in a focus group to discuss their experience with the portable device system. Information obtained from these participants will be used to update the instruction manual and make any needed modifications to the overall study procedures. Phase 2: Participants enrolled in Phase 2 will be sent an FIA kit along with an instruction manual describing how to use the device (e.g. how to put the device on, how to turn it on/off, how to charge it etc.). No in-person instructions will be provide to the participants other than to read the manual, but participants will be able to contact study team if they have questions. The participants will then be asked to wear the sensors for 1 month. Data collection for each subject will subsequently be conducted entirely via the Internet. Participants will be called weekly to determine if there are any device issues. At the completion of the trial, participants will be asked to participate in a focus group to discuss their experience with the portable device system. Information obtained from these participants will be used to update the instruction manual again and make any needed modifications to the overall study procedures for use in future studies. Both focus groups as well as the in-person training session from Phase 1 will be videotaped for review and analysis.

Phase: Observational Lead Sponsor: Michael J. Fox Foundation
Trial ID: 003946 Sponsor Type: Nonprofit
Country: United States Additional Collaborators or Sponsors: Clintrex LLC
Estimated Enrollment: 0 Study Start Date:
Estimated Study Completion Date: Source:
Study Website: Not Applicable

More Inclusion & Exclusion Criteria

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