RecruitingNCT05883371

IMPACT - AndHealth Autoimmune Research Registry

Investigating Mechanisms of Participatory Autoimmune Condition Treatment (IMPACT): An Outcomes Research Registry of a Comprehensive Approach to Autoimmune Disorders


Sponsor

AndHealth

Enrollment

2,500 participants

Start Date

Jun 8, 2023

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This research registry is collecting information from people with autoimmune conditions — like rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis — who are taking biologic or DMARD medications. The goal is to understand how well these treatments work in real-world settings. **You may be eligible if...** - You are between 18 and 70 years old - You can read and understand English - You have been diagnosed with rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis - You are currently taking or have been recommended a biologic or DMARD medication for your condition **You may NOT be eligible if...** - You are pregnant, breastfeeding, or planning to become pregnant in the next 12 months - You have advanced liver or kidney disease - You have had an organ transplant - You are currently being treated for cancer - You have poorly controlled mental illness - You have a terminal illness - You currently use opioids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRoot-cause autoimmune treatment program

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)

AndHealth

Columbus, Ohio, United States

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NCT05883371


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