Creating Health Course Study for People With Rheumatological Conditions

NCT07180537 | Recruiting

• 1 other identifier: 202503591
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Sjogren's Syndrome; Systemic Lupus Erythematosus; Mixed Connective Tissue Disease; Psoriatic Arthritis

Keywords

diet; self-care; internet course

Outcome Measures

Primary Outcomes (8)

• Modified Fatigue Impact Scale (MFIS)

  Change in MFIS survey questions, scores range from 0-84, lower score is better.

  Day 0 to Month 3

• Modified Fatigue Impact Scale (MFIS)

  Change in MFIS survey questions, scores range from 0-84, lower score is better.

  Day 0 to Month 6

• Fatigue Severity Scale (FFS)

  Change in FSS survey questions, scores range from 1-63, lower score is better.

  Day 0 to Month 3

• Fatigue Severity Scale (FFS)

  Change in FSS survey questions, scores range from 1-63, lower score is better.

  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

  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

  Day 0 to Month 6

• Rapid 3

  Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better

  Day 0 to Month 3

• Rapid 3

  Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better

  Day 0 to Month 6

Secondary Outcomes (7)

• Mediterranean and Paleo Diet Screener

  Baseline

• Mediterranean and Paleo Diet Screener

  Month 3

• Mediterranean and Paleo Diet Screener

  Month 6

• Hospital Anxiety and Depression Scale (HADS)

  Day 0 to Month 3

• Hospital Anxiety and Depression Scale (HADS)

  Day 0 to Month 6

Study Arms (2)

Immediate Intervention: Creating Health Online course

EXPERIMENTAL

This arm will begin the intervention immediately after randomization

Behavioral: Creating Health Online Course

Delayed Intervention: Creating Health Online course

OTHER

This is the control arm.

Behavioral: Delayed access to Creating Health Online Course

Interventions

Creating Health Online Course BEHAVIORAL

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

Immediate Intervention: Creating Health Online course

Delayed access to Creating Health Online Course BEHAVIORAL

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

Delayed Intervention: Creating Health Online course

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Terry L. Wahls: lead

Study Sites (1)

Univeristy of Iowa

Iowa City, Iowa, 52246, United States

RECRUITING

Related Publications (6)

• Sandikci SC, Ozbalkan Z. Fatigue in rheumatic diseases. Eur J Rheumatol. 2015 Sep;2(3):109-113. doi: 10.5152/eurjrheum.2015.0029. Epub 2015 Sep 1.

  PMID: 27708942 BACKGROUND

• Wolfe F, Hawley DJ, Wilson K. The prevalence and meaning of fatigue in rheumatic disease. J Rheumatol. 1996 Aug;23(8):1407-17.

  PMID: 8856621 BACKGROUND

• Nikolaus S, Bode C, Taal E, van de Laar MA. Fatigue and factors related to fatigue in rheumatoid arthritis: a systematic review. Arthritis Care Res (Hoboken). 2013 Jul;65(7):1128-46. doi: 10.1002/acr.21949.

  PMID: 23335492 BACKGROUND

• Omdal R, Mellgren SI, Koldingsnes W, Jacobsen EA, Husby G. Fatigue in patients with systemic lupus erythematosus: lack of associations to serum cytokines, antiphospholipid antibodies, or other disease characteristics. J Rheumatol. 2002 Mar;29(3):482-6.

  PMID: 11908560 BACKGROUND

• Miller FW. The increasing prevalence of autoimmunity and autoimmune diseases: an urgent call to action for improved understanding, diagnosis, treatment, and prevention. Curr Opin Immunol. 2023 Feb;80:102266. doi: 10.1016/j.coi.2022.102266. Epub 2022 Nov 26.

  PMID: 36446151 BACKGROUND

• Dean C, Parks S, Titcomb TJ, Arthofer A, Meirick P, Grogan N, Ehlinger MA, Bisht B, Fox SS, Daack-Hirsch S, Snetselaar LG, Wahls TL. Facilitators of and Barriers to Adherence to Dietary Interventions Perceived by Women With Multiple Sclerosis and Their Support Persons. Int J MS Care. 2022 Sep-Oct;24(5):235-241. doi: 10.7224/1537-2073.2021-051. Epub 2022 May 26.

  PMID: 36090239 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Sjogren's Syndrome; Lupus Erythematosus, Systemic; Mixed Connective Tissue Disease; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Terry L Wahls, MD, Other

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

319 384 5002; ch-studies@uiowa.edu

Mary Ehlinger, BS

CONTACT

319 384 5002; AIM-Studies@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will be masked
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: waitlist control

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)