Creating Health Online Course for Rheumatoid Arthritis

Overseen By Mary Ehlinger, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Terry L. Wahls

Disqualifiers: Other study, Special diets, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates an online health program called the Creating Health Online Course, designed to improve diet and self-care for individuals with rheumatoid arthritis and similar conditions. The program focuses on reducing fatigue and enhancing quality of life through better nutrition and self-care practices. Participants will be divided into two groups: one will start the program immediately, while the other will begin later. This trial suits individuals diagnosed with conditions like rheumatoid arthritis or lupus who have internet access and an interest in online health courses. As an unphased trial, it provides a unique opportunity to explore innovative online health solutions for managing chronic conditions.

What prior data suggests that this online course is safe for patients with rheumatological conditions?

Research has shown that digital health tools, such as the Creating Health Online Course, are generally safe and well-tolerated by individuals with rheumatoid arthritis and similar conditions. One study examined how these digital tools can help manage rheumatoid arthritis by tracking patient-reported outcomes without causing harm. Specifically, using these tools did not lead to any major negative effects or side effects.

Additionally, a review compared virtual care to traditional care for rheumatoid arthritis and found that virtual care is both effective and safe for patients. This suggests that using an online course like Creating Health is likely safe for participants in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for rheumatoid arthritis, which often involve medications like NSAIDs, DMARDs, or biologics, the Creating Health Online Course offers a non-pharmaceutical approach. Researchers are excited about this trial because it explores how an online educational program can empower patients to manage their symptoms and improve their quality of life. This course could potentially provide an accessible, cost-effective supplement to existing treatment plans, offering a new avenue for patient engagement and self-management.

What evidence suggests that the Creating Health Online Course is effective for improving diet and self-care in patients with rheumatoid arthritis?

Research shows that online health programs can benefit people with rheumatoid arthritis (RA) and similar conditions. Studies have found that digital health tools help patients understand their condition better, adhere to treatments, and improve their quality of life. For instance, using a smartphone app to track symptoms has been linked to reduced disease activity. Patients in educational programs reported better knowledge and confidence in managing their condition. This trial will evaluate the effectiveness of the Creating Health Online Course for RA. Participants in the immediate intervention arm will start the course immediately after randomization, while those in the delayed intervention arm will serve as the control group. These findings suggest that an online course could improve health outcomes for people with RA and related conditions. ^{2 5 6 7 8}

Who Is on the Research Team?

Terry L Wahls, MD, Other

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain rheumatological conditions like Rheumatoid Arthritis, Sjogren's Syndrome, Lupus, Mixed Connective Tissue Disease, or Psoriatic Arthritis. Participants must be fluent in English, have high-speed internet access and devices for streaming content. They should be willing to take an online health course and complete surveys for 6 months. People with cognitive impairments that affect online learning are not eligible.

Inclusion Criteria

My mental status has been assessed for cognitive function.

I am fluent in speaking and reading English.

I have high-speed internet and a device for video calls.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 virtual visit

Baseline Assessment

Participants complete baseline assessments and are randomized into study arms

1-2 weeks

1 virtual visit

Treatment

Participants engage in the online wellness program, including dietary and self-care modules

6 months

3 virtual visits (months 0, 3, and 6)

Follow-up

Participants are monitored for quality of life and fatigue outcomes

6 months

3 virtual visits (months 0, 3, and 6)

What Are the Treatments Tested in This Trial?

Interventions

• Creating Health Online Course

Trial Overview The study tests the effectiveness of an online health program aimed at improving diet and self-care among patients with specific rheumatological conditions. It will evaluate how well the program reduces fatigue and improves quality of life by comparing immediate access to the course versus delayed access.

How Is the Trial Designed?

Group I: Immediate Intervention: Creating Health Online course Experimental Treatment 1 Intervention

This arm will begin the intervention immediately after randomization

Group II: Delayed Intervention: Creating Health Online course Experimental Treatment 1 Intervention

This is the control arm.

Who Is Running the Clinical Trial?

Terry L. Wahls

Lead Sponsor

Trials

6

Recruited

400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8686289/

The effectiveness of e-learning in patient education delivered ... Secondary outcomes are improved knowledge of rheumatoid arthritis, adherence to medication, health literacy level and quality of life. Outcomes ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2803893

Management of Rheumatoid Arthritis With a Digital Health ... These findings suggest that assessing patient-reported outcomes using a smartphone application resulted in clinical improvement in disease activity.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3963622/

Development of a Rheumatoid Arthritis Education Program ... The objectives of this education program will increase RA patients' knowledge, attitude, self-efficacy, and how to deal with disease and its consequences and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0003496725043171

Association of health literacy with disease outcomes in ... This study aims to conduct a systematic literature review (SLR) to summarise associations between health literacy and inflammatory arthritis (IA) ...

5. nature.com nature.com/articles/s41746-024-01013-y

Digital health technologies and machine learning augment ... Digital measures of health status captured during daily life could greatly augment current in-clinic assessments for rheumatoid arthritis (RA).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10105314/

Management of Rheumatoid Arthritis With a Digital Health ... This randomized clinical trial investigates whether using digital health applications to assess patient-reported outcomes could result in ...

7. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr.24586

Systematic Review of Outcomes and Patient Experience With ... Objective To conduct a systematic review on patient outcomes of virtual care compared to conventional care in rheumatoid arthritis (RA), ...

8. the-rheumatologist.org the-rheumatologist.org/article/new-research-at-acr-convergence-2025-demonstrates-impact-of-rise-registry-data-on-rheumatology-outcomes/

New Research at ACR Convergence 2025 Demonstrates ... New Research at ACR Convergence 2025 Demonstrates Impact of RISE Registry Data on Rheumatology Outcomes. From the College | October 19, 2025.