Status:
RECRUITING
Creating Health Course Study for People With Rheumatological Conditions
Lead Sponsor:
Terry L. Wahls
Conditions:
Rheumatoid Arthritis
Sjogren's Syndrome
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoi...
Detailed Description
The goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Must be age 18 and older, at time of consent.
- 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.
- Must have access to high-speed internet with devices capable of audio/video streaming.
- 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.
- 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:
- 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)).
- Participation in another research study investigating an intervention (treatments, medications, diet, or exercise). Participation in observation-only studies are not excluded.
- Currently following a modified Paleolithic, low-fat nutrient-dense vegetarian, or Mediterranean diet with 75% OR greater reported compliance.
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07180537
Start Date
December 1 2025
End Date
December 31 2027
Last Update
January 8 2026
Active Locations (1)
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1
Univeristy of Iowa
Iowa City, Iowa, United States, 52246