Recruiting

Observational Study

Sponsor:

AndHealth

Code:

NCT05883371

Conditions

Arthritis, Rheumatoid

Arthritis, Psoriatic

Psoriasis

Ankylosing Spondylitis

Autoimmune Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Root-cause autoimmune treatment program

Study Details

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

Study ID

NCT05883371

Start date

Jun 8, 2023

Status verified date

May, 2023

Completion date

May 22, 2028

Anticipated

Primary completion date

Nov 22, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Sonja Horner

614-697-3296shorner@andhealth.com

Locations

AndHealth

Recruiting

Columbus, Ohio, United States, 43215

More Information

Sponsor

AndHealth

Last update posted

Jun 29, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AndHealth on 2023-06-29.