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Pancreatitis, ChronicNCT06907953

CZI Rare As One: Co-designing an App and Wearable Based Compass for Rare Diseases

An observational study of Pancreatitis, Chronic and Sarcoidosis, run by 4YouandMe at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The CZI Rare As One study is a Chan Zuckerberg Initiative funded study that aims to co-design and pilot test unique symptom tracking and transmitting apps across 5 different sub-arms that includes individuals with Long COVID, Pancreatitis, Sarcoidosis, Vasolin-Containing Protein (VCP) disease and Primary Ciliary… Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
Pancreatitis, Chronic, Sarcoidosis, VCP Disease
How many people
239 participants
Where
1 siteUnited States
Study dates
6 Feb 2025to 1 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with a clinician confirmed diagnosis of pancreatitis, sarcoidosis, PCD, VCP disease and LongCOVID (suspected diagnosis).

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • 4YouandMe

    New York, New York, 11021-3326

Other trials in United States

About this study

The CZI Rare As One study is a Chan Zuckerberg Initiative funded study that aims to co-design and pilot test unique symptom tracking and transmitting apps across 5 different sub-arms that includes individuals with Long COVID, Pancreatitis, Sarcoidosis, Vasolin-Containing Protein (VCP) disease and Primary Ciliary disease (PCD). This study aims to use multimodal digital health tools to enable patients to self-monitor their symptoms in passive and active ways.

Read the detailed description

The CZI Rare As One Study is a pilot, beta testing that aims to recruit ~50 participants per disease group (LongCOVID, pancreatitis, sarcoidosis, VCP disease, and PCD) totalling 250 participants. Participants will be instructed to us a co-designed study app alongside specific wearable and smart devices as outlined below for 5 months.

LongCOVID: Oura ring, Empatica EmbracePlus wristband, Lumia ear device Pancreatitis: Oura ring, Empatica EmbracePlus wristband Sarcoidosis: Oura ring VCP Disease: Oura ring, MIR Smart One Spirometer, Apple Watch series 8 PCD: Oura ring, MIR Smart One Spirometer

Research staff (engagement specialists) will check-in via phone every 2 weeks with participants to provide support, troubleshoot tech problems, solicit study-related feedback and collect context related information about the participants disease.

The study app collects symptom specific information for each disease group, measures of disease burden, quality of life, and information about participants routines through self-reported surveys and tasks (cognitive, active tasks) and passive phone metadata derived from SensorKit's Research framework and an Android equivalent framework.

Being tested
Observational - no intervention
Medical subject headings
Pancreatitis, Chronic, Sarcoidosis, Post-Acute COVID-19 Syndrome, Signs and Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational - no interventionOther

    Pilot, observational study - no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention

    Proportion of participants retained for the full study

    Measured: 5 months

  2. Adherence

    Average adherence of daily app use surveys/tasks over follow-up

    Measured: 5 months

Secondary outcomes (2)

  1. Usability

    Patient reported usability of study devices (qualitative). Participants will be asked over bi-weekly phone check-in calls a number of questions relating to study experience outlined below. Qualitative synthesis of this unstructured text will be completed to understand themes.

    IS THERE ANYTHING THAT IS PARTICULARLY MAKING YOU WANT TO USE THE STUDY APP LESS? IS THERE ANYTHING ABOUT THE STUDY APP THAT YOU DIDN'T EXPECT TO ENJOY BUT YOU DO? WHAT ARE THE PRIMARY BARRIERS TO USING THE STUDY APP? 1 FORGETFULNESS; 2 INCONVENIENCE; 3 HEALTH-RELATED BARRIERS; 4 ENVIRONMENTAL BARRIERS; 5 TECHNOLOGICAL BARRIERS; 6 DIGITAL LITERACY; 7 TASK FATIGUE; 8 LOW PERCEIVED UTILITY; 9 PRIVACY \& CONFIDENTIALITY CONCERNS; 10 OTHER

    WHAT ARE THE PRIMARY BARRIERS TO USING THE OURA RING?

    1 FORGETFULNESS; 2 INCONVENIENCE; 3 HEALTH-RELATED BARRIERS; 4 ENVIRONMENTAL BARRIERS; 5 TECHNOLOGICAL BARRIERS; 6 DIGITAL LITERACY; 7 TASK FATIGUE; 8 LOW PERCEIVED UTILITY; 9 PRIVACY \& CONFIDENTIALITY CONCERNS; 10 OTHER

    Measured: 5 months

  2. Benefits/Harms

    Patient reported benefits and harms from using the study devices (qualitative). Participants will be asked over bi-weekly phone check-in calls a number of questions relating to study experience outlined below. Qualitative synthesis of this unstructured text will be completed to understand themes.

    ARE THERE ANY FEATURES OF THE STUDY APP THAT YOU ARE FINDING BENEFICIAL TO YOUR HEALTH / WELLNESS ?

    ARE THERE ANY FEATURES OF THE STUDY APP THAT YOU ARE FINDING NOT BENEFICIAL / HARMFUL TO YOUR HEALTH / WELLNESS ?

    ARE THERE ANY FEATURES OF THE OURA RING / OURA APP THAT YOU ARE FINDING BENEFICIAL TO YOUR HEALTH / WELLNESS ?

    ARE THERE ANY FEATURES OF THE OURA RING / OURA APP THAT YOU ARE FINDING NOT BENEFICIAL / HARMFUL TO YOUR HEALTH / WELLNESS ?

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2025
  2. Study start6 Feb 2025
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06907953
Sponsor's protocol ID
4UCZIRAO
Status last verified
Aug 2025
First submitted
31 Jan 2025
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data, source code, and study findings will be made open source via public repositories (TBD), GitHub, and published documents.

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatitis, Chronic and Sarcoidosis, run by 4YouandMe at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06907953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

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