RecruitingNot ApplicableNCT07180537

Creating Health Course Study for People With Rheumatological Conditions

Transforming Health Habits: Evaluating an Online Wellness Program for Individuals With Rheumatological Conditions


Sponsor

Terry L. Wahls

Enrollment

200 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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), 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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria10

  • 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 Criteria4

  • 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.

Interventions

BEHAVIORALCreating 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

BEHAVIORALDelayed 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


Locations(1)

Univeristy of Iowa

Iowa City, Iowa, United States

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NCT07180537


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