Registry for evaluating a comprehensive approach to autoimmune disorders
Investigating Mechanisms of Participatory Autoimmune Condition Treatment (IMPACT): An Outcomes Research Registry of a Comprehensive Approach to Autoimmune Disorders
This study is testing a personalized treatment program for people with autoimmune disorders to see if combining different therapies helps them feel better over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | AndHealth Industry-sponsored |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05883371 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to assess the effectiveness of the AndHealth program, which combines pharmacological and non-pharmacological therapies tailored to individual patients with autoimmune disorders. Participants will be monitored over a period of up to five years, with evaluations based on validated labs, patient-reported outcomes, and medication usage. The focus is on conditions such as rheumatoid arthritis, psoriatic arthritis, psoriasis, and ankylosing spondylitis, allowing for a personalized treatment approach under the guidance of licensed physicians and health coaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a documented diagnosis of rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis who are currently using or recommended biologic or DMARD medications.
Not a fit: Patients who are pregnant, have advanced liver or kidney disease, or are currently being treated for cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could lead to improved management and outcomes for patients with autoimmune disorders.
How similar studies have performed: While this approach is innovative, similar registries have shown promise in evaluating personalized treatment strategies for chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults 18 to 70 years of age 2. Able to understand and write English 3. Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects 4. Documented diagnosis and current use/recommendation for biologic or DMARD medications to treat rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis. Exclusion Criteria: 1. Pregnant, breastfeeding, or planning to become pregnant in the next 12 months 2. Advanced liver or kidney disease 3. Previous organ transplant or awaiting organ transplant 4. Actively being treated for cancer 5. Poorly-controlled mental illness (i.e., schizophrenia, bipolar, current eating disorder) 6. Has a terminal illness 7. Current opioid use
Where this trial is running
Columbus, Ohio
- AndHealth — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Myles Spar, MD — AndHealth
- Study coordinator: Sonja Horner
- Email: shorner@andhealth.com
- Phone: 614-697-3296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.