Solve Together: Capturing Patient Reported Outcomes and Recruiting for Clinical Studies of ME/CFS, and Long COVID.

Study Overview
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Brief Summary
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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
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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/

Official Title
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Solve Together: Capturing Patient Reported Outcomes and Recruiting for Clinical Studies of ME/CFS, and Long COVID.

Conditions
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ME/CFS, Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ME/CFS, Patients with Long Covid Those without ME/CFS or Long Covid
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| People with ME/CFS<br>No intervention will be administered. | |
| People with Long-COVID<br>No intervention will be administered. | |
| Healthy Controls<br>No intervention will be administered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotypic data collection | Collect a large, well-characterized longitudinal dataset to understand causes and identify treatments for ME/CFS and long-COVID. | 36 months | 
| Subtyping | Use the patient reported outcomes to identify ME/CFS and Long Covid disease subtypes. | 36 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |