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NCT07180537 | RECRUITING | Rheumatoid Arthritis

Creating Health Course Study for People With Rheumatological Conditions
Sponsor:

Terry L. Wahls

Information provided by (Responsible Party):

Terry L. Wahls

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), 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.

Condition or disease

Rheumatoid Arthritis

Sjogren's Syndrome

Systemic Lupus Erythematosus

Mixed Connective Tissue Disease

Psoriatic Arthritis

Intervention/treatment

Creating Health Online Course

Delayed access to Creating Health Online Course

Phase

NA

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 rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA),. 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. 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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : SINGLE
Masking Description : Investigator will be masked
Primary Purpose : SUPPORTIVE_CARE
Official Title : Transforming Health Habits: Evaluating an Online Wellness Program for Individuals With Rheumatological Conditions
Actual Study Start Date : 2025-12-01
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Creating Health Course Study for People With Rheumatological Conditions

Location Details

NCT07180537

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Locations

RECRUITING

United States, Iowa

Univeristy of Iowa

Iowa City, Iowa, United States, 52246