IMPACT - AndHealth Autoimmune Research Registry

June 28, 2023 updated by: AndHealth

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • AndHealth
        • Contact:
          • Myles Spar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be composed of AndHealth patients with a documented diagnosis and current use or recommendation for biologic or DMARD medications to treat the autoimmune disorders under study (rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis) and who elect to participate in the outcomes research registry.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS - Global Health
Time Frame: Baseline 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.
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
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.
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
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.
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
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.
Baseline and approximately quarterly thereafter for up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire for Anxiety and Depression (PHQ4)
Time Frame: Baseline and approximately quarterly thereafter for up to 5 years
Change in PHQ4 is a secondary outcome for all patients. All patients will provide the PHQ4 at baseline and at follow-up visits, as is warranted by scores. This 4-item questionnaire is a common measure of anxiety and depression symptoms. PHQ4 scores range from 0 to 12, with higher scores indicating worse symptoms.
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
Change in DAS28 is a secondary outcome for rheumatoid arthritis patients. The DAS28 is a measure of disease activity in rheumatoid arthritis that will be assessed at baseline and all follow-up visits for participants with rheumatoid arthritis. DAS stands for 'disease activity score' and 28 joints are examined in this assessment. DAS28 scores range from 0 to 9.4, with higher scores indicating worse symptoms.
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
Change in PASI is a secondary outcome for psoriasis and psoriatic arthritis patients. The PASI is a measure of psoriasis and psoriatic arthritis severity that will be assessed at baseline and all follow-up visits for participants with psoriasis or psoriatic arthritis. This common clinical measure selects a representative area of psoriasis for each body region. The intensity of redness, thickness, and scaling of the psoriasis is assessed by the clinician. PASI scores range from 0 to 72, with higher scores indicating worse symptoms.
Baseline and approximately quarterly thereafter for up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AndHealth

Investigators

  • Principal Investigator: Myles Spar, MD, AndHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Estimated)

November 22, 2023

Study Completion (Estimated)

May 22, 2028

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

May 29, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 044-AND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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