RecruitingRecruiting
IMPACT - AndHealth Autoimmune Research Registry
NCT05883371 · AndHealth
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Investigating Mechanisms of Participatory Autoimmune Condition Treatment (IMPACT): An Outcomes Research Registry of a Comprehensive Approach to Autoimmune Disorders
About this study
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.
Eligibility 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
Study design
Enrollment target: 2500 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-06-08
Estimated completion: 2028-05-22
Last updated: 2023-06-29
Interventions
Other: Root-cause autoimmune treatment program
Primary outcomes
- • PROMIS - Global Health (Baseline and approximately quarterly thereafter for up to 5 years)
- • Routine Assessment of Patient Index Data 3 (RAPID 3) (Baseline and approximately quarterly thereafter for up to 5 years)
- • Dermatology Life Quality Index (DLQI) (Baseline and approximately quarterly thereafter for up to 5 years)
Sponsor
AndHealth · industry
Contacts & investigators
ContactSonja Horner · contact · shorner@andhealth.com · 614-697-3296
InvestigatorMyles Spar, MD · principal_investigator, AndHealth
All locations (1)
AndHealthRecruiting
Columbus, Ohio, United States