IMPACT - AndHealth Autoimmune Research Registry

Part of paid clinical trials in Columbus, Ohio.

Sponsor
AndHealth
Study ID
NCT05883371
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Root-cause autoimmune treatment program — OTHER
    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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
AndHealthColumbusOhio43215
Myles Spar, MD

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