Clinical trial NCT05883371: IMPACT - AndHealth Autoimmune Research Registry
Official title: Investigating Mechanisms of Participatory Autoimmune Condition Treatment (IMPACT): An Outcomes Research Registry of a Comprehensive Approach to Autoimmune Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthritis, Rheumatoid
Arthritis, Psoriatic
Psoriasis
Ankylosing Spondylitis
Autoimmune Diseases
Lead sponsor: AndHealth
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of AndHealth patients with a documented diagnosis and current use or recommendation for biologic or DMARD medications to treat the autoimmune disorders under study (rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis) and who elect to participate in the outcomes research registry.

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.


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

Primary outcomes:
measure: PROMIS - Global Health
timeFrame: Baseline and approximately quarterly thereafter for up to 5 years
measure: Routine Assessment of Patient Index Data 3 (RAPID 3)
timeFrame: Baseline and approximately quarterly thereafter for up to 5 years
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline and approximately quarterly thereafter for up to 5 years
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline and approximately quarterly thereafter for up to 5 years
Secondary outcomes:
measure: Patient Health Questionnaire for Anxiety and Depression (PHQ4)
timeFrame: Baseline and approximately quarterly thereafter for up to 5 years
measure: Disease Activity Score 28 (DAS28)
timeFrame: Baseline and approximately quarterly thereafter for up to 5 years
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline and approximately quarterly thereafter for up to 5 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: AndHealth
state: Ohio
Study officials:
affiliation: AndHealth
name: Myles Spar, MD
role: PRINCIPAL_INVESTIGATOR
References: