NCT05883371Recruiting
IMPACT - AndHealth Autoimmune Research Registry
Investigating Mechanisms of Participatory Autoimmune Condition Treatment (IMPACT): An Outcomes Research Registry of a Comprehensive Approach to Autoimmune Disorders
Source: ClinicalTrials.gov · Last updated 29 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2500 (estimated)
- First submitted
- 5 May 2023
- Start date
- 8 Jun 2023
- Primary completion date
- 22 Nov 2023
- Lead sponsor
- AndHealth
- NCT number
- NCT05883371
What you commit to
- Study type: Observational
- Planned participants: 2500
- From 8 Jun 2023 to the primary completion date, 22 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous organ transplant or awaiting organ transplant
Other illness
- Advanced liver or kidney disease
- Actively being treated for cancer
- Poorly-controlled mental illness (i.e., schizophrenia, bipolar, current eating disorder)
- Has a terminal illness
Other
- Pregnant, breastfeeding, or planning to become pregnant in the next 12 months
- Current opioid use
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AndHealth Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.