Clinical Trial 53504

Columbus, OH 43215


Summary:

The purpose of this research registry is to evaluate the effectiveness of a root-cause medical approach (“AndHealth program”) for autoimmune disorders in clinical practice. The clinical approach under study involves a combination of pharmacological and non-pharmacological therapies offered under the care of a licensed physician, with the support of a clinical pharmacist, health coaches, and other providers. While guidance is provided, the therapeutic approach is personalized to the individual needs of patients and this research registry aims to evaluate practice-based outcomes. The autoimmune disorders of focus in this registry include rheumatoid arthritis, psoriatic arthritis, psoriasis, and ankylosing spondylitis. A variety of validated laboratory and questionnaire outcomes will be assessed among participating patients over a period of up to five years to evaluate the long-term effectiveness of this approach. Of particular note, participants in the research registry may opt out of the study at any time and continue with the clinical care being provided, for which consent is obtained separately from the consent obtained to track outcomes in the research registry. This is solely a research registry, and not a repository, as no biological samples (laboratory samples, tissues, etc.) of any sort will be stored.

PURPOSE OF STUDY

●               AndHealth is conducting a research study to determine how a comprehensive approach to patient care may improve health outcomes among people with autoimmune disorders.

●               This is a research registry in which outcomes from your clinical care will be collected, completely deidentified, and analyzed.

●               This is not a clinical trial, there is no control group, and all study participants will receive clinical care. 

●               If you decide to take part in this research study, your participation will last up to 5 years.

●               You will be one of approximately 5,000 participants.  

●               This is a research study and your participation is completely voluntary. You may ask questions or stop participation at any time.



Criteria:

You may be eligible if you:

  • Are willing to receive care from AndHealth
  • Are 18 to 70 years of age
  • Are able to understand and write English
  • Have a documented diagnosis and current use/recommendation for biologic or DMARD medications to treat rheumatoid arthritis, psoriatic arthritis, psoriasis, or  ankylosing spondylitis
  • Complete health cquestionnaires on the AndHealth app
  • Allow your Andhealth physician to provide your de-identified clnical and lab data for analysis


Qualified Participants May Receive:

The clinical approach under study involves a combination of pharmacological and non-pharmacological therapies offered under the care of a licensed physician, with the support of a clinical pharmacist, health coaches, and other providers. While guidance is provided, the therapeutic approach is personalized to the individual needs of patients and this research registry aims to evaluate practice-based outcomes.

PAYMENT TO PARTICIPANTS

Upon receipt of your completed questionnaires on a quarterly basis, you will receive compensation for your participation in the autoimmune study.

  • $100.00 dollars upon completion of screening/enrollment.
  • $25.00 dollars per quarter  for completing all surveys in that quarter.You will be given a 10-day grace period to complete your surveys after receiving an email prompt to complete the quarterly surveys. This will be considered an “on time” response.
  • $150.00 dollars at the end of each year if all surveys have been completed in that year on time.
  • You will receive a minimum of $100 and a maximum of $550 in the first year and $450 for each subsequent year of your participation in the study.
  • You will receive your incentives in the form of gift cards.

 


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.