NCT07180537 · Terry L. Wahls
Creating Health Course Study for People With Rheumatological Conditions
What this study is about
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 rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), Additionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.
View original scientific 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 rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), Additionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.
Interventions
BEHAVIORAL
Creating Health Online Course
Immediate access to an online audio and video course with education about strategies to grow and improve resilience, diet quality, exercise, stress reduction and self-care
BEHAVIORAL
Delayed access to Creating Health Online Course
Delayed access (12-week delay) to an online audio and video course with education about strategies to grow and improve resilience, diet quality, exercise, stress reduction and self-care
Primary outcome measures
Modified Fatigue Impact Scale (MFIS)
Time frame: Day 0 to Month 3
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Modified Fatigue Impact Scale (MFIS)
Time frame: Day 0 to Month 6
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Fatigue Severity Scale (FFS)
Time frame: Day 0 to Month 3
Change in FSS survey questions, scores range from 1-63, lower score is better.
Fatigue Severity Scale (FFS)
Time frame: Day 0 to Month 6
Change in FSS survey questions, scores range from 1-63, lower score is better.
Short form 36 (SF 36)
Time frame: Day 0 to Month 3
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better
Short form 36 (SF 36)
Time frame: Day 0 to Month 6
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better
Rapid 3
Time frame: Day 0 to Month 3
Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better
Rapid 3
Time frame: Day 0 to Month 6
Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Iowa City, Iowa
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 8, 2026 · Source of record for eligibility and locations