IMPACT - AndHealth Autoimmune Research Registry
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- AndHealth
- Study ID
- NCT05883371
- Status
- Recruiting
Conditions
- Ankylosing Spondylitis
- Arthritis, Psoriatic
- Arthritis, Rheumatoid
- Autoimmune Diseases
- Psoriasis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Root-cause autoimmune treatment program — OTHERThe 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.
Study Details
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.
Key Dates
- Start date
- Jun 8, 2023
- Status verified
- May 2023
- Primary completion
- Nov 22, 2023
- Completion
- May 22, 2028
Study Design
- Enrollment
- 2,500 participants (estimated)
Primary Outcome Measure
PROMIS - Global Health [ Time Frame: Baseline and approximately quarterly thereafter for up to 5 years ]
Central Contacts
- Sonja Horner614-697-3296
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| AndHealth | Columbus | Ohio | 43215 | Myles Spar, MD |
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