Clinical trial NCT04806620: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Acute COVID-19 Syndrome
ME/CFS
Keywords: Long COVID
Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Lead sponsor: Solve ME/CFS Initiative
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a study of individuals with ME/CFS, individuals with long-COVID and healthy controls.

Brief 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.

Detailed 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/

Eligibility criteria: Inclusion Criteria:

* Patients with ME/CFS,
* Patients with Long Covid
* Those without ME/CFS or Long Covid

Primary outcomes:
measure: Phenotypic data collection
timeFrame: 36 months
measure: Subtyping
timeFrame: 36 months
measure: Passive data collection
timeFrame: 36 months
Secondary outcomes:
measure: Demographics
timeFrame: 36 months
measure: Comorbitities
timeFrame: 36 months
measure: Quality of Life and Functional Status
timeFrame: 36 months
measure: Symptoms
timeFrame: 36 months
Other outcomes:
measure: Electronic Heath Record Linkage
timeFrame: 36 months
measure: Clinical Study Participation
timeFrame: 36 months
Locations:
city: Los Angeles
country: United States
facility: Solve ME/CFS Initiative
state: California
Study officials:
affiliation: Solve ME/CFS Initiative, Inc.
name: Hsin-hao T Hsiao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramiller A, Mudie K, Seibert E, Whittaker S. The Facilitation of Clinical and Therapeutic Discoveries in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Related Diseases: Protocol for the You + ME Registry Research Platform. JMIR Res Protoc. 2022 Aug 10;11(8):e36798. doi: 10.2196/36798.