Co-designing an app and wearable for tracking symptoms of rare diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CZI Rare As One initiative focuses on co-designing and pilot testing a symptom tracking app and wearable devices for patients with rare diseases, including Long COVID, pancreatitis, sarcoidosis, VCP disease, and PCD. The study aims to recruit approximately 250 participants, with around 50 individuals from each disease group, who will use the app and wearables over a 5-month period. Participants will receive bi-weekly check-ins from research staff to provide support and gather feedback. The app will collect data on symptoms, disease burden, quality of life, and daily routines through self-reported surveys and passive data collection from mobile devices.

Why it matters

Who can join: the full rules

GENERAL INCLUSION CRITERIA

* 18+ years (except 14+ years for the PCD sub-arm)
* own a personal mobile device and use this phone to download and use the app for the study
* resides in the US
* be willing to use the study wearable devices
* have a clinician confirmed or suspected diagnosis of one of the 5 rare conditions as defined below in the cohort specific inclusion criteria below:

Long COVID sub-arm:

* have experienced Long COVID for at least 3 months as a continuous, relapsing and remitting, or progressive condition; and
* have experienced within the past week at least one or more of the following symptoms that started or significantly worsened following a COVID infection: shortness of breath, cough, persistent fatigue, post-exertional malaise (worsening of symptoms or fatigue after minimal activity), difficulty concentrating, memory changes, recurring headache, lightheadedness, fast heart rate, sleep disturbance, problems with taste or smell, bloating, constipation, and diarrhea.
* symptom(s) of COVID significantly impact your ability to work, ability to give care, enjoy recreational activities or reduce your quality of life
* Own a personal iPhone 8 (iOS 16+) or Android smartphone (version 12 or newer)

Sarcoidosis sub-arm

* have a diagnosis of sarcoidosis confirmed by a doctor, and have experienced fatigue for at least 2 days in the past month
* Own a personal iPhone 6s (iOS 15+) or Android smartphone (version 12 or newer)

Pancreatitis sub-arm

* have a diagnosis of chronic pancreatitis confirmed by a doctor, have had at least 1 pancreatitis flare in the past year, and have not had a surgery that completely removed the pancreas
* Own a personal iPhone 6s (iOS 15+) or Android smartphone (version 12 or newer)

VCP disease sub-arm

* have a clinician confirmed pathogenic VCP mutation or a family history of VCP disease, and are experiencing symptoms associated with the disease
* Own a personal iPhone 8 (iOS 16+) or Android smartphone (version 12 or newer)

PCD sub-arm

* a genetic test that confirms two abnormal copies (one on each gene) of a gene associated with PCD. These abnormalities must be classified as "pathogenic" or "likely pathogenic."; Or an abnormal electron microscopy cilia biopsy done in a PCD center.; and symptoms consistent with PCD.
* Own a personal iPhone 8 (iOS 16+) or Android smartphone (version 12 or newer)

Where it's running

• 4YouandMe
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Stephen Friend, MD, PhD
• Email: friend@4youandme.org
• Phone: 0012154213073

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.