AndHealth Autoimmune Research Registry for Arthritis and Psoriasis

This is a research registry called IMPACT, which is studying the AndHealth autoimmune treatment program for conditions like rheumatoid arthritis, psoriatic arthritis, psoriasis, and ankylosing spondylitis. This program combines different therapies, both medications and other approaches, personalized to each patient. The study aims to see how effective this comprehensive approach is over time. You might be able to join if you are between 18 and 70 years old, can understand English, and have a documented diagnosis of one of these autoimmune conditions for which you are currently using or recommended biologic or DMARD medications. The study will measure your overall health, disease activity, and quality of life over approximately five years. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will observe participants receiving the AndHealth program. It plans to enroll 2500 participants.
What's involved
You would have assessments at the start and then approximately every three months for up to five years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to five years after starting the program.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05883371

IMPACT - AndHealth Autoimmune Research Registry

Recruiting
Not specifiedAges 18–70Observational
AndHealth
~2,500 participants
Updated 2023-06-29 on ClinicalTrials.gov
What's tested:Root-cause autoimmune treatment program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PROMIS - Global Health
Measured over Baseline and approximately quarterly thereafter for up to 5 years
+3 more outcomes measured
Arthritis, Rheumatoid
Arthritis, Psoriatic
Psoriasis
Ankylosing Spondylitis
Autoimmune Diseases
1 sites across 1 states
Ohio1
  • Myles Spar, MD · PRINCIPAL_INVESTIGATOR · AndHealth

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  • PROMIS - Global HealthBaseline and approximately quarterly thereafter for up to 5 years

    Change in PROMIS - Global Health is a co-primary outcome for all patients. All patients will provide the PROMIS - Global Health at baseline and all follow-up visits. The 10-item PROMIS Global Health is a patient-reported survey that was designed for use in complex heterogeneous patient populations. The PROMIS Global Health measures overall health status across several physical and mental health areas. PROMIS t-scores range from 16.2 to 67.7 (Physical Health) and 21.2 to 67.6 (Mental Health) with higher scores indicating better health.

  • Routine Assessment of Patient Index Data 3 (RAPID 3)Baseline and approximately quarterly thereafter for up to 5 years

    Change in RAPID 3 is a co-primary outcome for rheumatoid arthritis \& psoriatic arthritis patients. All patients with rheumatoid and psoriatic arthritis will provide the RAPID 3 at baseline and all follow-up visits. This 3-item questionnaire is a rheumatological disease activity index that is calculated to reflect severity of disease. Scores range from 0 to 30 with higher scores indicating worse symptoms.

  • Dermatology Life Quality Index (DLQI)Baseline and approximately quarterly thereafter for up to 5 years

    Change in DLQI is a co-primary outcome for psoriasis patients. All patients with psoriasis and psoriatic arthritis will provide the DLQI at baseline and all follow-up visits. This 10-item questionnaire is a common measure of the health-related quality of life for skin disorders. DLQI scores range from 0 to 30, with higher scores indicating worse quality of life.

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)Baseline and approximately quarterly thereafter for up to 5 years

    Change in BASDAI is a co-primary outcome for ankylosing spondylitis patients. All patients with ankylosing spondylitis will provide the BASDAI at baseline and all follow-up visits. This 6-item questionnaires is a brief, validated measure of ankylosing spondylitis activity. BASDAI scores range from 0 to 10, with higher scores indicating worse symptoms.