IMPACT - AndHealth Autoimmune Research Registry

NCT ID: NCT05883371

Last Updated: 2023-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-08

Study Completion Date

2028-05-22

Brief Summary

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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.

Detailed Description

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Conditions

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Arthritis, Rheumatoid Arthritis, Psoriatic Psoriasis Ankylosing Spondylitis Autoimmune Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Root-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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adults 18 to 70 years of age
2. Able to understand and write English
3. Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
4. Documented diagnosis and current use/recommendation for biologic or DMARD medications to treat rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis.

Exclusion Criteria

1. Pregnant, breastfeeding, or planning to become pregnant in the next 12 months
2. Advanced liver or kidney disease
3. Previous organ transplant or awaiting organ transplant
4. Actively being treated for cancer
5. Poorly-controlled mental illness (i.e., schizophrenia, bipolar, current eating disorder)
6. Has a terminal illness
7. Current opioid use
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AndHealth

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Myles Spar, MD

Role: PRINCIPAL_INVESTIGATOR

AndHealth

Locations

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AndHealth

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sonja Horner

Role: CONTACT

Phone: 614-697-3296

Email: [email protected]

Facility Contacts

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Myles Spar, MD

Role: primary

Other Identifiers

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044-AND

Identifier Type: -

Identifier Source: org_study_id