An interventional study of Creating Health Online Course and Delayed access to Creating Health Online Course in Rheumatoid Arthritis, Sjogren's Syndrome and Systemic Lupus Erythematosus, sponsored by Terry L. Wahls. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Terry L. Wahls · Not applicable, Interventional, and Supportive care
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), anxiety disorders, depressive disorders and moderate depression.
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.
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), anxiety disorders, depressive disorders, and moderate depression. . Additionally, we 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.
Once the eligibility criteria are established and consent is obtained, investigators will invite study participants randomized to the intervention arm to the online course via email. Participants will be required to create a password to access the course. The online course and supplementary resources will be hosted on a secure website through the UIowa Canvas Classroom platform. Participants will progress through the online health course modules similarly to a non-graded online course. Within the course, there are exercises and personal assessments designed to enhance the participants' experience and success.
The course will cover various topics, including modules on developing an inner game plan, a food intervention plan, a physical intervention plan, and an increased resilience plan. The fourth module will propose various strategies to improve health beyond diet and exercise, such as the use of supplements, light therapy, detoxification, improved sleep, stress reduction, and other strategies to enhance bodily resilience.
Participants are encouraged to communicate and collaborate with their healthcare teams to personalize their treatment and determine whether the strategies suggested in the course are appropriate for their individual healthcare needs. This study aims to provide dietary education to a broader sample size than previously studied, including patients with limited resources such as financial constraints and geographic barriers that restrict access to registered dietitians experienced in dietary instruction for various rheumatological conditions. There is a growing interest in delivering education and support through an online platform to improve diet quality and self-care practices for autoimmune patients.
This study will utilize a randomized single-blind waitlist control design to evaluate the impact of the online course, which includes materials covering a modified Paleolithic elimination (MPE) diet, nutrient-dense vegetarian diets, Mediterranean diets, stress reduction techniques, and exercise strategies designed for autoimmune patients. Data will be collected in the short term (after 3 months) and long term (at the end of 6 months) to analyze the effects of the online wellness program on quality of life (QoL) and related outcomes among individuals with RA, SS, SLE, MCTD, PsA, anxiety disorders, depressive disorders, and moderate depression. .
Investigators will request that study participants complete their baseline assessments within approximately 7 to 14 days following consent. Participants will receive an individual link to their baseline assessments via REDCap. Patients will be randomized into different study arms based on their baseline fatigue severity scores.
The proposed study will be conducted entirely online. The schedule will include three virtual visits at three-month intervals (months 0, 3, and 6). Online questionnaires will be distributed via REDCap to assess fatigue, quality of life, and dietary information according to the study schedule (months 0, 3, and 6).
330 studies on the registry are indexed under Sjogren's Syndrome; 99 are open to participants now.
This study's planned enrollment of 400 is above the median of 50 across 218 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Terry L. Wahls is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Compared within Sjogren's Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arthritis, Rheumatoid. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must be fluent in both speaking and reading English.
*Study participant must be able to read and comprehend 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.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will begin the intervention immediately after randomization
Behavioral: Creating Health Online Course
This is the control arm.
Behavioral: Delayed access to 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
Also known as: Online wellness 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
Also known as: Online wellness course
Modified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Time frame: Day 0 to Month 3
Modified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Time frame: Day 0 to Month 6
Fatigue Severity Scale (FFS)
Change in FSS survey questions, scores range from 1-63, lower score is better.
Time frame: Day 0 to Month 3
Fatigue Severity Scale (FFS)
Change in FSS survey questions, scores range from 1-63, lower score is better.
Time frame: Day 0 to Month 6
Short form 36 (SF 36)
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better
Time frame: Day 0 to Month 3
Short form 36 (SF 36)
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better
Time frame: Day 0 to Month 6
Rapid 3
Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better
Time frame: Day 0 to Month 3
Rapid 3
Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better
Time frame: Day 0 to Month 6
Mediterranean and Paleo Diet Screener
Mediterranean and Paleo Diet Screener questions, scores range 0-14, higher is better
Time frame: Baseline
Mediterranean and Paleo Diet Screener
Mediterranean and Paleo Diet Screener questions, scores range 0-14, higher is better
Time frame: Month 3
Mediterranean and Paleo Diet Screener
Mediterranean and Paleo Diet Screener questions, scores range 0-14, higher is better
Time frame: Month 6
Hospital Anxiety and Depression Scale (HADS)
Change in HADS survey questions, scores range from 0-42, lower score is better.
Time frame: Day 0 to Month 3
Hospital Anxiety and Depression Scale (HADS)
Change in HADS survey questions, scores range from 0-42, lower score is better.
Time frame: Day 0 to Month 6
Multi-Dimensional Health Assessment Questionnaire (MDHAQ)
Change in MDHAQ survey questions, scores range from 0 to 40, lower is better
Time frame: Day 3 to Month 3
Multi-Dimensional Health Assessment Questionnaire (MDHAQ)
Change in MDHAQ survey questions, scores range from 0 to 40, lower is better
Time frame: Day 3 to Month 6
Patient Health Questionnaire -8
Questions about mood, scores range from 0 to 32, lower is better
Time frame: Day 0 to Month 3
Patient Health Questionnaire -8
Questions about mood, scores range from 0 to 32, lower is better
Time frame: Day 0 to Month 6
General Anxiety Disorder -7
Questions about anxiety, scores range from 0 to 28, lower is better
Time frame: Day 0 to month 3
General Anxiety Disorder -7
Questions about anxiety, scores range from 0 to 28, lower is better
Time frame: Day 0 to month 6
Perceived Deficits Questionnaire
Questions about thinking functions, scores range from 0 to 80, lower is better
Time frame: Day 0 to month 3
Perceived Deficits Questionnaire
Questions about thinking functions, scores range from 0 to 80, lower is better
Time frame: Day 0 to month 6
Single sleep questionnaire
Question about sleep quality, score ranges from 0 to 10, higher is better
Time frame: Day 0 to month 3
Single sleep questionnaire
Question about sleep quality, score ranges from 0 to 10, higher is better
Time frame: Day 0 to month 6
UCLA loneliness scale
Question about loneliness, scores range from 20 to 80, lower is better
Time frame: Day 0 to month 3
UCLA loneliness scale
Question about loneliness, scores range from 20 to 80, lower is better
Time frame: Day 0 to month 6
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Terry L. Wahls