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NCT05883371 | RECRUITING | Arthritis, Rheumatoid

IMPACT - AndHealth Autoimmune Research Registry
Sponsor:

AndHealth

Brief Summary:

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.

Condition or disease

Arthritis, Rheumatoid

Arthritis, Psoriatic

Psoriasis

Ankylosing Spondylitis

Autoimmune Diseases

Intervention/treatment

Root-cause autoimmune treatment program

Study Type : OBSERVATIONAL
Estimated Enrollment : 2500 participants
Official Title : Investigating Mechanisms of Participatory Autoimmune Condition Treatment (IMPACT): An Outcomes Research Registry of a Comprehensive Approach to Autoimmune Disorders
Actual Study Start Date : 2023-06-08
Estimated Primary Completion Date : 2023-11-22
Estimated Study Completion Date : 2028-05-22

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
IMPACT - AndHealth Autoimmune Research Registry

Location Details

NCT05883371

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Ohio

AndHealth

Columbus, Ohio, United States, 43215