IMPACT - AndHealth Autoimmune Research Registry
Investigating Mechanisms of Participatory Autoimmune Condition Treatment (IMPACT): An Outcomes Research Registry of a Comprehensive Approach to Autoimmune Disorders
AndHealth
2,500 participants
Jun 8, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria7
- 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
Interventions
The AndHealth autoimmune treatment program combines validated and guideline-driven approaches along with emerging evidence-based modalities. The program includes a comprehensive assessment of disease severity, analysis of root causes and comorbidities, and an evaluation of the patient's readiness for implementing important lifestyle changes. This is followed by the development of an optimized and personalized plan to achieve and sustain clinical remission while monitoring their progress. Each patient participating in the AndHealth program receives a personalized care plan developed by the patient's medical provider in collaboration with a team of healthcare specialists. Helping a patient manage everyday lifestyle decisions can have a profound effect on their ability to achieve and maintain remission. The AndHealth Program has organized these into four basic groups of lifestyle behaviors: 1.) Dietary/Nutrition, 2.) Sleep/Circadian, 3.) Stress/HPA axis, and 4.) Physical Activity.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05883371