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Recruiting NCT05883371

IMPACT - AndHealth Autoimmune Research Registry

— Observational Arthritis, Rheumatoid Arthritis, Psoriatic Psoriasis Ankylosing Spondylitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Root-cause autoimmune treatment program.
Who it may be relevant to
Registry conditions: Arthritis, Rheumatoid, Arthritis, Psoriatic, Psoriasis, Ankylosing Spondylitis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other 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 pa

Primary outcome measures

  • PROMIS - Global Health [Time frame: Baseline and approximately quarterly thereafter for up to 5 years]
  • Routine Assessment of Patient Index Data 3 (RAPID 3) [Time frame: Baseline and approximately quarterly thereafter for up to 5 years]
  • Dermatology Life Quality Index (DLQI) [Time frame: Baseline and approximately quarterly thereafter for up to 5 years]
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time frame: Baseline and approximately quarterly thereafter for up to 5 years]
Secondary outcome measures (3)
  • Patient Health Questionnaire for Anxiety and Depression (PHQ4) [Time frame: Baseline and approximately quarterly thereafter for up to 5 years]
  • Disease Activity Score 28 (DAS28) [Time frame: Baseline and approximately quarterly thereafter for up to 5 years]
  • Psoriasis Area and Severity Index (PASI) [Time frame: Baseline and approximately quarterly thereafter for up to 5 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • AndHealth — Columbus

Identifiers

NCT: NCT05883371 · 044-AND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗