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.
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.
Must have access to high-speed internet with devices capable of audio/video streaming.
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.
Crossover
Creating Health Online Course
BehavioralImmediate 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
BehavioralDelayed 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
Modified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Modified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Fatigue Severity Scale (FFS)
Change in FSS survey questions, scores range from 1-63, lower score is better.
Fatigue Severity Scale (FFS)
Change in FSS survey questions, scores range from 1-63, lower score is better.
Mediterranean and Paleo Diet Screener
Mediterranean and Paleo Diet Screener questions, scores range 0-14, higher is better
Mediterranean and Paleo Diet Screener
Mediterranean and Paleo Diet Screener questions, scores range 0-14, higher is better
Mediterranean and Paleo Diet Screener
Mediterranean and Paleo Diet Screener questions, scores range 0-14, higher is better
Hospital Anxiety and Depression Scale (HADS)
Change in HADS survey questions, scores range from 0-42, lower score is better.
Click on the lead sponsor to view all of their trials.
Terry L. Wahls
Lead sponsor
University of Iowa
Sponsor institution
