IMPACT - AndHealth Autoimmune Research Registry
Recruiting · NCT05883371 · Observational (researchers observe without assigning treatment) · Lead sponsor: AndHealth
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a patient research registry aimed at evaluating the effectiveness of a comprehensive, root-cause medical approach ("AndHealth program") for autoimmune disorders. This approach involves a combination of pharmacological and non-pharmacological therapies offered under the care of a licensed physician with the support of health coaches. While protocol guidance is provided, the therapeutic approach is personalized to the individual needs of patients. The autoimmune disorders of focus in this registry include rheumatoid arthritis, psoriatic arthritis, psoriasis and ankylosing spondylitis. A variety of validated labs, patient-reported outcomes, and medication usage will be assessed among participating patients over a period of up to five years to evaluate the long-term effectiveness of this approach.
Who can take part
Inclusion criteria
- Adults 18 to 70 years of age
- Able to understand and write English
- Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
- Documented diagnosis and current use/recommendation for biologic or DMARD medications to treat rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis.
Exclusion criteria
- Pregnant, breastfeeding, or planning to become pregnant in the next 12 months
- Advanced liver or kidney disease
- Previous organ transplant or awaiting organ transplant
- Actively being treated for cancer
- Poorly-controlled mental illness (i.e., schizophrenia, bipolar, current eating disorder)
- Has a terminal illness
- Current opioid use
Where it is running
2 locations listed across 1 US state.
- AndHealth - Columbus, Ohio, United States
- AndHealth - Columbus, Ohio, United States