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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
200
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 (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
Univeristy of Iowa
Iowa City, Iowa, United States
RECRUITINGModified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Time frame: Day 0 to Month 3
Modified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Time frame: Day 0 to Month 6
Fatigue Severity Scale (FFS)
Change in FSS survey questions, scores range from 1-63, lower score is better.
Time frame: Day 0 to Month 3
Fatigue Severity Scale (FFS)
Change in FSS survey questions, scores range from 1-63, lower score is better.
Time frame: 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
Time frame: 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
Time frame: Day 0 to Month 6
Rapid 3
Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better
Time frame: Day 0 to Month 3
Rapid 3
Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better
Time frame: Day 0 to Month 6
Mediterranean and Paleo Diet Screener
Mediterranean and Paleo Diet Screener questions, scores range 0-14, higher is better
Time frame: Baseline
Mediterranean and Paleo Diet Screener
Mediterranean and Paleo Diet Screener questions, scores range 0-14, higher is better
Time frame: Month 3
Mediterranean and Paleo Diet Screener
Mediterranean and Paleo Diet Screener questions, scores range 0-14, higher is better
Time frame: Month 6
Hospital Anxiety and Depression Scale (HADS)
Change in HADS survey questions, scores range from 0-42, lower score is better.
Time frame: Day 0 to Month 3
Hospital Anxiety and Depression Scale (HADS)
Change in HADS survey questions, scores range from 0-42, lower score is better.
Time frame: Day 0 to Month 6
Multi-Dimensional Health Assessment Questionnaire (MDHAQ)
Change in MDHAQ survey questions, scores range from 0 to 40, lower is better
Time frame: Day 3 to Month 3
Multi-Dimensional Health Assessment Questionnaire (MDHAQ)
Change in MDHAQ survey questions, scores range from 0 to 40, lower is better
Time frame: Day 3 to Month 6
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