Actively Recruiting
Investigating Mechanisms of Participatory Autoimmune Condition Treatment (IMPACT): An Outcomes Research Registry of a Comprehensive Approach to Autoimmune Disorders
Led by AndHealth · Updated on 2023-06-29
2500
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a comprehensive root-cause medical approach called the AndHealth program for autoimmune disorders including rheumatoid arthritis, psoriatic arthritis, psoriasis, and ankylosing spondylitis. This patient research registry aims to assess the long-term effectiveness of combining pharmacological and non-pharmacological therapies personalized to individual patient needs under licensed physician care with health coach support. The AndHealth program includes a thorough assessment of disease severity, root causes, comorbidities, and patient readiness for lifestyle changes. It develops a personalized care plan focused on achieving and sustaining clinical remission. The program organizes lifestyle behaviors into four groups: dietary/nutrition, sleep/circadian rhythms, stress/HPA axis management, and physical activity. This approach is guided by protocols but tailored for each patient. Participants are monitored for up to five years with validated laboratory tests, patient-reported outcomes, and medication usage. Key outcomes measured approximately quarterly include PROMIS Global Health, RAPID 3, Dermatology Life Quality Index, and Bath Ankylosing Spondylitis Disease Activity Index. Additional assessments include anxiety and depression questionnaires and disease activity scores. This registry tracks progress and safety over time to understand the benefits and challenges of this comprehensive treatment approach.
CONDITIONS
Brief Title
IMPACT - AndHealth Autoimmune Research Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or recommendation for biologic or DMARD medications to treat rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis
You will not qualify if you...
- 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 such as schizophrenia, bipolar disorder, or current eating disorder
- Has a terminal illness
- Current opioid use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - Up to 5 years
Participants who undergo routine care in the AndHealth autoimmune treatment program are observed with periodic assessments.
Baseline visit and approximately quarterly visits thereafter
Trial Site Locations
Total: 1 location
1
AndHealth
Columbus, Ohio, United States, 43215
Actively Recruiting
Research Team
S
Sonja Horner
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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