Transforming Health Habits: Evaluating an Online Wellness Program for Individuals With Rheumatological Conditions and Mood Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Modified Fatigue Impact Scale (MFIS)
研究概览
简要总结
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.
详细描述
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, 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, anxiety disorders, depressive disorders, and moderate depression. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Investigator will be masked
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Immediate Intervention: Creating Health Online course
This arm will begin the intervention immediately after randomization
干预措施: Creating Health Online Course (Behavioral)
Delayed Intervention: Creating Health Online course
This is the control arm.
干预措施: Delayed access to Creating Health Online Course (Behavioral)
结局指标
主要结局
Modified Fatigue Impact Scale (MFIS)
时间窗: Day 0 to Month 3
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Fatigue Severity Scale (FFS)
时间窗: Day 0 to Month 3
Change in FSS survey questions, scores range from 1-63, lower score is better.
Short form 36 (SF 36)
时间窗: Day 0 to Month 3
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better
Rapid 3
时间窗: Day 0 to Month 3
Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better
Modified Fatigue Impact Scale (MFIS)
时间窗: Day 0 to Month 6
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Fatigue Severity Scale (FFS)
时间窗: Day 0 to Month 6
Change in FSS survey questions, scores range from 1-63, lower score is better.
Short form 36 (SF 36)
时间窗: Day 0 to Month 6
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better
Rapid 3
时间窗: Day 0 to Month 6
Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better
次要结局
- Mediterranean and Paleo Diet Screener(Month 6)
- Hospital Anxiety and Depression Scale (HADS)(Day 0 to Month 6)
- Patient Health Questionnaire -8(Day 0 to Month 3)
- Patient Health Questionnaire -8(Day 0 to Month 6)
- General Anxiety Disorder -7(Day 0 to month 3)
- General Anxiety Disorder -7(Day 0 to month 6)
- Perceived Deficits Questionnaire(Day 0 to month 3)
- Perceived Deficits Questionnaire(Day 0 to month 6)
- Single sleep questionnaire(Day 0 to month 3)
- Single sleep questionnaire(Day 0 to month 6)
- UCLA loneliness scale(Day 0 to month 3)
- UCLA loneliness scale(Day 0 to month 6)
- Mediterranean and Paleo Diet Screener(Baseline)
- Mediterranean and Paleo Diet Screener(Month 3)
- Hospital Anxiety and Depression Scale (HADS)(Day 0 to Month 3)
- Multi-Dimensional Health Assessment Questionnaire (MDHAQ)(Day 3 to Month 3)
- Mediterranean and Paleo Diet Screener(Month 6)
- Hospital Anxiety and Depression Scale (HADS)(Day 0 to Month 6)
- Multi-Dimensional Health Assessment Questionnaire (MDHAQ)(Day 3 to Month 6)
研究者
Terry L. Wahls
Clinical Professor
University of Iowa