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

NCT06907953 | Completed

• 1 other identifier: 4UCZIRAO
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 1

Brief 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 disease (PCD). This study aims to use multimodal digital health tools to enable patients to self-monitor their symptoms in passive and active ways.

Conditions

Pancreatitis, Chronic; Sarcoidosis; VCP Disease; Long COVID; PCD; Symptoms and Signs; Wearables

Outcome Measures

Primary Outcomes (2)

• Retention

  Proportion of participants retained for the full study

  5 months

• Adherence

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

  5 months

Secondary Outcomes (2)

• Usability

  5 months

• Benefits/Harms

  5 months

Interventions

Observational - no intervention OTHER

Pilot, observational study - no intervention

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• + 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
• 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)

Sponsors & Collaborators

• 4YouandMe: lead
• Patient Led Research Collaborative (PLRC): collaborator
• Mission: Cure: collaborator
• Cure VCP Disease: collaborator
• Foundation for Sarcoidosis Research (FSR): collaborator
• Primary Ciliary Disease Foundation (PCD): collaborator

Study Sites (1)

4YouandMe

New York, New York, 11021-3326, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Sarcoidosis; Post-Acute COVID-19 Syndrome; Signs and Symptoms

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: April 3, 2025
• Study Start: February 6, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: 1 year of study completion
• Access Criteria: All qualified researchers with an approved IRB protocol

Locations

US (1)