Creating Health online course for people with rheumatological conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional project invites eligible adults to receive an online course delivered through the University of Iowa Canvas platform, with a delayed-access group serving as comparison. Participants create a password and progress through non-graded modules that include an inner game plan, a food intervention plan, a physical intervention plan, and resilience strategies, plus exercises and personal assessments. Outcomes focus on fatigue and quality of life and the investigators will document barriers and facilitators to using the online program. Enrollment requires English fluency, informed consent, and high-speed internet with audio/video-capable devices.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. A diagnosis of one of the following: Rheumatoid Arthritis (RA), Sjogren's Syndrome, Systemic lupus erythematosus (SLE), Mixed connective tissue disease (MCTD), or Psoriatic Arthritis (PsA), as documented by their treating specialist or primary care provider, as reported by the participant.
2. Must be age 18 and older, at time of consent.
3. Must be fluent in both speaking and reading English.

   \*Study participant must be able to read and comprehend informed consent document and speak with study staff about study document content. Study staff will use discretion in determining whether the study participant can clearly communicate with staff and comprehend the study material during the consent call or prior to the call.
4. Must have access to high-speed internet with devices capable of audio/video streaming.
5. Must be willing to participate in an online health course designed to improve dietary intake and self-care routines to help improve cellular function and health, and complete online surveys over the course of a 6-month period.
6. Individuals must pass the Short Portable Mental Status Questionnaire with scores for normal mental functioning (up to 2 errors). Cognitive impairment as measured by the SPMS Questionnaire could interfere with the completion of the online course.

SCORING\* 0-2 errors: normal mental functioning 3-4 errors: mild cognitive impairment 5-7 errors: moderate cognitive impairment 8-10 errors: severe cognitive impairment

\*Allow one more error for a subject with only a grade school education. Allow one less error for a subject with education beyond high school.

Source: Pfeiffer, E. (1975). A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. Journal of American Geriatrics Society. 23, 433-41.

Exclusion criteria:

1. Inability to provide informed consent, including participation in a consent call conducted via Zoom with the study team during business hours (8:00 a.m. to 5:00 p.m. Central Time (Chicago)).
2. Participation in another research study investigating an intervention (treatments, medications, diet, or exercise). Participation in observation-only studies are not excluded.
3. Currently following a modified Paleolithic, low-fat nutrient-dense vegetarian, or Mediterranean diet with 75% OR greater reported compliance.
4. Any diagnosis or condition that is contraindicated from starting a gentle exercise program (ex. poorly controlled diseases of the heart, kidney, or liver in the prior 12 months, or severe psychiatric disease, e.g., schizophrenia, making adherence to study procedures difficult.

Where it's running

• Univeristy of Iowa
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: Terry L Wahls, MD, Other — University of Iowa
• Study coordinator: Study Coordinator
• Email: ch-studies@uiowa.edu
• Phone: 319 384 5002

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry and biorepository for rheumatic diseases

  This study is collecting samples and health information from adults with rheumatic diseases at Yale clinics to help researchers learn more about these conditions and improve future treatments.

  Recruiting Yale University · New Haven, Connecticut · NCT04402086

• Follow-up care for new cases of polyarthritis in children and young adults

  This program will try standardized medical follow-up for children and young adults (≤50) with new-onset JIA, RA, psoriatic/seronegative/undifferentiated arthritis, SLE, or diffuse systemic sclerosis who are treatment-naïve or treated ≤3 months to see if more patients reach disease control or remission.

  Recruiting Université Catholique de Louvain · Brussels · NCT07000916

• Study on how diet affects autoimmune diseases in rheumatology patients

  This study looks at how changing to a healthier diet, like the Mediterranean diet, might help people with autoimmune diseases feel better and manage their symptoms.

  Recruiting University of Central Florida · Orlando, Florida · NCT06339957

• Assessing how patient feedback affects treatment adjustments for autoimmune diseases

  This study is testing if regular feedback from patients with autoimmune diseases like gout and rheumatoid arthritis can help doctors make better treatment decisions and improve patient care.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT05927688

• Educational tool for melanoma patients with autoimmune diseases

  This study is testing a new educational tool to help melanoma patients with autoimmune diseases understand their treatment options better and see how easy it is for them to use.

  Recruiting M.D. Anderson Cancer Center · Houston, Texas · NCT04751396

• Using nivolumab to treat patients with autoimmune disorders and advanced cancer

  This study is testing if nivolumab can safely help people with autoimmune disorders who also have advanced cancer by looking at how well it works and what side effects it might cause.

  Recruiting at 40 sites Phase 1 National Cancer Institute (NCI) · Birmingham, Alabama and 51 other locations · NCT03816345

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.