KickStart30: A 30-Day Intervention for Patients With Rheumatoid Arthritis (RA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in Generalized Anxiety Disorder-7 (GAD-7)
研究概览
简要总结
This study explores the efficacy and feasibility of a self-management wellness intervention that is integrated, prescriptive, and trackable in a population of patients with Rheumatoid Arthritis (RA) taking a biologic. This 30-day wellness intervention (called "KickStart30") combines five wellness elements: exercise, mindfulness, sleep, social connectedness, and nutrition. Additionally, the program requires that participants implement 5 wellness interventions daily for the 30-day study, document daily online adherence, complete daily HERO (happiness, enthusiasm, resilience, and optimism) exercises to improve mental wellness, and complete online program forms before and after the 30-day intervention. Participants are assessed pre- and post-intervention to determine whether the intervention promotes wellness behavior changes.
详细描述
It is expected that this 30-day integrated, prescriptive, and trackable wellness intervention (combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition) will be found to be an efficacious program for those with Rheumatoid Arthritis taking a biologic or a JAK inhibitor.
Traditionally mental health and other specialties like rheumatology have focused primarily on the diagnosis and treatment of illness rather than incorporating wellness as an essential element of treatment. Those in the helping professions are trained to diagnose health problems with treatment typically focusing on symptom reduction. More recently, mental health and other healthcare specialties like rheumatology have initiated a conversation and subsequent research focusing on the importance of integrating elements of wellness into treatment. Rather than focusing solely on symptom reduction, some providers have begun incorporating elements of wellness promotion into treatment with favorable results.
To the best of our knowledge, even though there is abundant research supporting each of the KickStart30 elements (exercise, mindfulness, sleep, social connectedness, and nutrition) individually, there is no research exploring the effectiveness of an integrated, prescriptive, and trackable wellness intervention combining these five elements specific to a cohort of patients with RA. Therefore, this work will be unique in that it will collect both objective and subjective data to assess the feasibility and effectiveness of this type of wellness intervention. It will lend support to the growing body of research on the efficacy of wellness interventions for a variety of different health conditions, as well as a community-based population. Finally, it is hoped that positive results will yield increased access to and utilization of this type of intervention, thereby improving public health.
The recruitment period will be open for 12 months to obtain a maximum of 50 participants. The study population will be individuals, ages 18 and older, interested in improving their overall wellness and that self-identify as having Rheumatoid Arthritis and taking a biologic or a JAK inhibitor. Each participant will be engaged in the program for 30 days. To determine a participant's eligibility, study personnel will conduct a preliminary screening/orientation telephone interview. If the participant is determined to be eligible for the study based on the preliminary screening/orientation phone interview, study personnel will collect the participant's email address, physical mailing address, and assign the participant a unique identification code based on the order in which the participant was screened. The consent form outlines the purpose and design of the study, data to be collected, confidentiality standards, alternatives to participation, and contact information for research personnel. Participants will have the option to download a PDF of their signed consent form for their records at the time of signing/completion.
Study personnel will mail each participant a KickStart30 Workbook within one day of emailing participants their unique identification codes. Participants will be instructed to document adherence of their daily wellness practices and their daily HERO exercises online via Qualtrics, an online survey software. Participants can document their daily adherence using their computer and/or their smartphone as Qualtrics offers a mobile version of the Participant Tracking Form. A copy of the Participant Tracking Form will also be available in the KickStart30 Workbook so participants that prefer keeping a daily paper log can do so, and they can then transfer their program adherence information to the online Participant Tracking Form at their convenience throughout the program. The workbook will contain the participant's personal identification code; no personal identification will appear in the workbook in order to protect participant confidentiality. Participants will also receive daily motivational emails from MailChimp, which will provide general information about one of the five wellness elements and/or one of the HERO wellness traits, as well as encouragement to track their participation on a daily basis, and encouragement to contact study personnel via email with any questions and/or concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with Rheumatoid Arthritis (RA) by a Rheumatologist
- •Currently taking a biologic and/or a JaK inhibitor for the treatment of RA, including one or more of the following: Orencia (intravenous infusion or subcutaneous injection), Humira (subcutaneous injection), Kineret (subcutaneous injection), Cimzia (subcutaneous injection), Enbrel (subcutaneous injection), Simponi (subcutaneous injection), Simponi Aria (intravenous infusion), Remicade (intravenous infusion), Kevzara (subcutaneous injection), Rituxan (intravenous infusion), Actemra (intravenous infusion or subcutaneous injection), Olumiant (oral administration), Xeljanz (oral administration)
- •Interested in improving overall wellness
- •Not pregnant and no plans to get pregnant during the 30-day study
- •English-speaking
- •Must have access to a reliable Internet-enabled computer
- •Must possess basic computer skills
排除标准
- •Has not been diagnosed with RA by a Rheumatologist
- •Not currently taking a biologic or a JAK inhibitor for the treatment of RA
- •Not interested in improving overall wellness
- •Pregnant or plans to get pregnant during the 30-day study
- •Does not speak English
- •Does not have access to a reliable, Internet-enabled computer
- •Reports a lack of basic computer skills
- •Acutely suicidal and/or actively psychotic
结局指标
主要结局
Change in Generalized Anxiety Disorder-7 (GAD-7)
时间窗: 0, and 30 days
The GAD-7 is a seven-item self-report questionnaire for screening and measurement of severity of generalized anxiety disorder. Scores range from 0-21 (Lower scores = Less anxiety).
Change in Social Connectedness Scale (SCS)
时间窗: 0, and 30 days
The SCS is an 8-item questionnaire that assesses the degree to which people feel connected to others in their social environment. Scores range from 8 to 48. (Higher scores = More connectedness to others).
Post-Program Participant Questionnaire
时间窗: 0, and 30 days
A brief 6 question post study survey that captures participants' opinions about KickStart30.
Change in Patient Health Questionnaire-9 (PHQ-9)
时间窗: 0, and 30 days
The PHQ-9 is a nine-item depression self-report questionnaire for screening and measurement of severity of major depression. Scores range from 0-27 (Lower scores = Less depression).
Change in Sleep Condition Indicator (SCI)
时间窗: 0, and 30 days
The SCI is a brief 8-item screening tool to evaluate insomnia disorder. Scores range from 0-32 (Lower scores = Greater sleep problems).
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
时间窗: 0, and 30 days
The CPFQ is a brief 7-item scale designed to assess cognitive and physical functioning. Scores range from 7-42 (Lower scores = Higher levels of cognitive and physical functioning).
Change in World Health Organization Well-Being Index (WHO-5)
时间窗: 0, and 30 days
The WHO-5 Well-Being Index is a five-item self-report questionnaire covering 5 areas: positive mood, vitality, and general interests. Scores range from 0-25 (Higher scores = Higher levels of well-being).
Change in Mindful Attention Awareness Scale (MAAS)
时间窗: 0, and 30 days
The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness. Scores range from 15-90 (Higher scores = Higher levels of mindfulness).
Change in Brief Pain Inventory (BPI)
时间窗: 0, and 30 days
The BPI is an 8-item scale that assesses pain. Scores range from 0-10. (0 = No pain and 10 = Pain as bad as you can imagine).
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
时间窗: 0, and 30 days
The EADES is a 24-item sub-scale used to measure stress-related eating. Scores range from 24-120 (Lower scores = Greater emotion and stress-related eating).
Change in Sheehan Disability Scale (SDS)
时间窗: 0, and 30 days
The SDS is a 3-item measurement tool for assessing functional impairment in three inter-related domains: work/school, social, and family life. Scores range from 0-10 (Higher scores = Higher levels of functional impairment).
Change in HERO Wellness Scale
时间窗: 0, and 30 days
The HERO Wellness Scale is a brief 5-item scale designed to measure four wellness traits plus perceived mental wellness. Scores range from 0-50 (Lower scores = Lower levels of mental wellness).
Change in Health Assessment Questionnaire-II (HAQ-II)
时间窗: 0, and 30 days
The HAQ-II is a ten-item self-report questionnaire for assessing functional status in individuals with rheumatic disease. Scores range from 0-3.0 (Higher scores = Worse functioning and greater disability).
次要结局
未报告次要终点
研究者
Saundra Jain
Adjunct Clinical Affiliate, School of Nursing
University of Texas at Austin
