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

Recruiting

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

• Registration Number: NCT06907953
• Lead Sponsor: 4YouandMe

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.

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-31
• Study Start: 2025-02-06
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retention	5 months	Proportion of participants retained for the full study
Adherence	5 months	Average adherence of daily app use surveys/tasks over follow-up

Secondary Outcome Measures

Name	Time	Method
Benefits/Harms	5 months	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 ?
Usability	5 months	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

Trial Locations

Locations (1)

4YouandMe; 🇺🇸 New York, New York, United States