Creating Health online course for people with rheumatological conditions
Transforming Health Habits: Evaluating an Online Wellness Program for Individuals With Rheumatological Conditions
This project will test whether an online course about diet and self-care helps adults with rheumatoid arthritis, Sjogren's syndrome, lupus, mixed connective tissue disease, or psoriatic arthritis reduce fatigue and improve quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT07180537 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) with a clinician-documented diagnosis of rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, mixed connective tissue disease, or psoriatic arthritis who are fluent in English and have high-speed internet access and a device for streaming are ideal candidates.
Not a fit: People without reliable internet access, non-English speakers, those unable to use an online platform, or patients with rapidly progressive disease requiring immediate medical treatment may not benefit from this program.
Why it matters
Potential benefit: If successful, the program could reduce fatigue and improve quality of life by teaching practical diet and self-care strategies patients can apply at home.
How similar studies have performed: Prior online self-management and lifestyle interventions in rheumatic diseases have shown modest improvements in fatigue and quality of life, but comprehensive diet-focused online programs remain relatively under-studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Iowa City, Iowa
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.