RightFit
RecruitingNot applicable

Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an online health course to help people improve their diet and self-care. It will look at whether the course reduces tiredness and improves daily life, and what makes it easy or hard to use. The study focuses on people with certain immune system diseases and mood disorders, but joining requires one of the diseases listed below.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a doctor-documented diagnosis of rheumatoid arthritis or psoriatic arthritis (diseases that affect joints), Sjogren's syndrome (often causes dry eyes and mouth), lupus, or mixed connective tissue disease (diseases that can affect many body parts). You report this diagnosis to the study team.
  • Be age 18 or older when you agree to join.
  • Speak and read English well enough to understand the consent form and discuss study details with staff.
  • Have high-speed internet and a device that can play online audio and video.
  • Be willing to take the online diet and self-care course and complete online surveys over 6 months.
  • Pass a short memory and thinking test. Usually, you can make up to 2 errors. You may make up to 3 with only a grade school education, or up to 1 with education beyond high school.

Who can't join

  • Cannot give informed consent, meaning you understand the study and agree to join, or cannot join a Zoom consent call between 8 a.m. and 5 p.m. Central Time.
  • Are in another study testing a treatment, medicine, diet, or exercise program. Studies that only observe people are allowed.
  • Currently follow a modified Paleolithic diet, a low-fat vegetarian diet rich in nutrients, or a Mediterranean diet at least 75% of the time.
  • Have a condition that makes gentle exercise unsafe, such as poorly controlled heart, kidney, or liver disease in the past 12 months, or a severe mental illness, such as schizophrenia, that makes study tasks hard to follow.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

IA