Solve Together: A Data Collection Platform for the Collection of Patient and Control Health Information to Support Future Research That Will Accelerate Understanding of the Causes of and Possible Treatments for ME/CFS and Other Chronic Diseases, Including Post-viral Illnesses

Post-Acute COVID-19 Syndrome Clinical Trial

Official title:

Solve Together: A Data Collection Platform for the Collection of Patient and Control Health Information to Support Future Research That Will Accelerate Understanding of the Causes of and Possible Treatments for ME/CFS and Other Chronic Diseases, Including Post-viral Illnesses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04806620
• Other study ID #: 1
• Status: Recruiting
• Start date: July 5, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: January 2024
• Source: Solve ME/CFS Initiative
• Contact: Hsin-hao T Hsiao, PhD
• Phone: 704-364-0016
• Email: thsiao[@]solvecfs.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Solve Together is a platform designed to collect clinical data about post-infectious diseases, including ME/CFS and Long Covid. This data is made available to researchers and will be used to identify participants eligible for clinical studies. The platform also empowers patients to make reports for their doctors, connect medical records and/or a health-tracking wearable device, and identify their unique symptoms and health patterns.

Description:

Solve Together description coming soon.

The combination of data and integration with wearable technologies and EHRs will : (1) improve our understanding of the natural history, epidemiology, pathogenesis, resilience/susceptibility factors, disease subsets, and treatment of ME/CFS and long-COVID using a standardized set of demographic and longitudinal data; (2) build an infrastructure and resource to support a range of clinical research participation opportunities for these patients; (3) increase opportunities for collaboration between patients, providers, researchers, and industry.

Anyone 18 years of age and older is invited to sign up. After creating a profile and completing an informed consent via an online portal, participants fill out a series of surveys, including medical history, co-occurring conditions, symptoms, quality of life, and functional status. Participants receive email or text reminders to complete additional surveys to provide researchers with information about eligibility for clinical research.

Solve Together includes a mobile tracking app co-created with patients that allow participants to monitor symptoms and triggers and set pacing notifications.

Data are stored in a secure, encrypted database. Data are aggregated and anonymized before being made available on a secure platform for research.

This project is supported by Solve ME/CFS Initiative. You can learn more and sign up starting September 12, 2023, at https://solvecfs.org/research/solve-together/

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with ME/CFS,

• Patients with Long Covid

• Those without ME/CFS or Long Covid

Related Conditions & MeSH terms

• Chronic Disease
• Fatigue Syndrome, Chronic
• ME/CFS

Locations

Country	Name	City	State
United States	Solve ME/CFS Initiative	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Solve ME/CFS Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Electronic Heath Record Linkage	Link EHR data to patient-reported outcomes in order to better identify subgroups of ME/CFS and Long Covid	36 months
Other	Clinical Study Participation	Use the Solve Together Platform to identfy and invite eligible ME/CFSa nd Long Covid patients and controls ot participate in clinical studies with academic, CRO and pharmaceutical partners.	36 months
Primary	Phenotypic data collection	Collect a large, well-characterized longitudinal dataset to understand causes and identify treatments for ME/CFS and long-COVID.	36 months
Primary	Subtyping	Use the patient reported outcomes to identify ME/CFS and Long Covid disease subtypes.	36 months
Primary	Passive data collection	Collect data from wearables that allow us to track step counts, heart rate variability and other indicators without the burden of participant data entry. This is a new feature to the registry expected to launch in 2023.	36 months
Secondary	Demographics	Record basic demographic information of our Registry population including: age, race, ethnicity, income, education, employment, marital status. Demographic information is recorded at baseline and updated every 12 months.	36 months
Secondary	Comorbitities	Catalogue common comorbidities in our registry population. Participants provide information on diagnosed conditions, age of onset, and whether the condition is still active. Their conditions list can be updated over time.	36 months
Secondary	Quality of Life and Functional Status	Participants fill out the Short Form 36 Quality of Life survey (0-100) and a version of the Karnofsky Performance Scale modified (max of 100) for self-report over time.	36 months
Secondary	Symptoms	We want to catalogue the common symptoms of ME/CFS and long COVID and analyze the data for symptom-based phenotypes. We administer a survey to assess the frequency and severity of symptoms over time and provide access to a mobile app so participants can log data on their symptoms as often as daily.	36 months