Recruiting

Online Health Program

Sponsor:

Terry L. Wahls

Code:

NCT07180537

Conditions

Rheumatoid Arthritis

Sjogren's Syndrome

Systemic Lupus Erythematosus

Mixed Connective Tissue Disease

Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Creating Health Online Course

Delayed access to Creating Health Online Course

Study Details

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 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.

Conditions

Rheumatoid Arthritis

Sjogren's Syndrome

Systemic Lupus Erythematosus

Mixed Connective Tissue Disease

Psoriatic Arthritis

Study ID

NCT07180537

Start date

Dec 1, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Immediate Intervention: Creating Health Online course

This arm will begin the intervention immediately after randomization

other: Delayed Intervention: Creating Health Online course

This is the control arm.

Interventions

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

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 measure

  • Modified Fatigue Impact Scale (MFIS) [ Time Frame: Day 0 to Month 3 ]
  • Modified Fatigue Impact Scale (MFIS) [ Time Frame: Day 0 to Month 6 ]
  • Fatigue Severity Scale (FFS) [ Time Frame: Day 0 to Month 3 ]
  • Fatigue Severity Scale (FFS) [ Time Frame: Day 0 to Month 6 ]
  • Short form 36 (SF 36) [ Time Frame: Day 0 to Month 3 ]
  • Short form 36 (SF 36) [ Time Frame: Day 0 to Month 6 ]
  • Rapid 3 [ Time Frame: Day 0 to Month 3 ]
  • Rapid 3 [ Time Frame: Day 0 to Month 6 ]

Central Contacts and Locations

Central contacts

Locations

Univeristy of Iowa

Recruiting

Iowa City, Iowa, United States, 52246

Contacts

Principal Investigator:

Terry Wahls, MD

More Information

Sponsor

Terry L. Wahls

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • diet
  • self-care
  • internet course
  • anxiety
  • depression
  • Sjogren's
  • rheumatoid arthritis
  • lupus
  • fatigue
  • arthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Terry L. Wahls on 2026-08-10.