IMPACT - AndHealth Autoimmune Research Registry

NCT05883371 | Recruiting

• 1 other identifier: 044-AND
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Ankylosing Spondylitis; Autoimmune Diseases

Outcome Measures

Primary Outcomes (4)

• PROMIS - Global Health

  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)

  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)

  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)

  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 Outcomes (3)

• Patient Health Questionnaire for Anxiety and Depression (PHQ4)

  Baseline and approximately quarterly thereafter for up to 5 years

• Disease Activity Score 28 (DAS28)

  Baseline and approximately quarterly thereafter for up to 5 years

• Psoriasis Area and Severity Index (PASI)

  Baseline and approximately quarterly thereafter for up to 5 years

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AndHealth: lead

Study Sites (1)

AndHealth

Columbus, Ohio, 43215, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis

Study Officials

• Myles Spar, MD

  AndHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonja Horner

CONTACT

614-697-3296; shorner@andhealth.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 31, 2023
• Study Start: June 8, 2023
• Primary Completion: November 22, 2023
• Study Completion (Estimated): May 22, 2028
• Last Updated: June 29, 2023

Record last verified: 2023-05

Locations

US (1)