Smartphone App Mindfulness-Based Intervention for Patients With Rheumatic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Number of participants recruited
研究概览
简要总结
This study will assess the effect of a mindfulness meditation program administered via a smartphone application on health-related quality of life for patients with rheumatic disease.
详细描述
After obtaining written consent, participants will be asked to download and use the Calm meditation smartphone application everyday for a 30-day period. Participant demographics and clinical information will be collected at baseline. Participants will additionally be asked to complete questionnaires concerning health-related quality of life (HRQoL) as well as mental health, stress, and self-efficacy at baseline and at the end of the 30 day study period. A brief check-in via telephone will be conducted on day 15.
Participants using the calm app will be compared to participants receiving usual care who will be asked to complete identical sets of questionnaires. The participant may choose whether they join the Calm application vs usual care (questionnaires only) group on a voluntary basis; there is no pre-assignment. The Calm application is a publicly available program that is available to any patient independent of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Established patients of the Johns Hopkins (JH) Rheumatology Division will be eligible for participation.
- •Participants must have one of the following JH rheumatologist-diagnosed and/or confirmed diseases: inflammatory arthritis, scleroderma, myositis, Sjogren's syndrome, systemic lupus erythematosus, and vasculitis.
- •Participants must be at least 18 years of age to participate; there is no upper-bound age limit
- •Participants must have access to a smartphone or computer to access the Calm app (or webpage) as well as Redcap (which requires an email address) to access the questionnaires
排除标准
- 未提供
结局指标
主要结局
Number of participants recruited
时间窗: 2 years
The investigators' goal is to recruit 264 participants. The investigators will report the number of participants recruited which will be a measure of Percentage of target enrollment achieved.
Total number of minutes per participant
时间窗: 30 days
The program consists of a total of 150 minutes. The investigators will report the total number of minutes per participant as a measure of adherence to program.
次要结局
- Change in Depression as assessed by the PROMIS Global-29 profile(Baseline, 30 days)
- Change in Social participation as assessed by the PROMIS Global-29 profile(Baseline, 30 days)
- Change in Pain interference as assessed by the PROMIS Global-29 profile(Baseline, 30 days)
- Change in Sleep disturbance as assessed by the PROMIS Global-29 profile(Baseline, 30 days)
- Change in Fatigue as assessed by the PROMIS Global-29 profile(Baseline, 30 days)
- Change in Depression as assessed by the PROMIS depression CAT(Baseline, 30 days)
- Change in Self-Efficacy for managing emotions as assessed by the PROMIS self-efficacy for managing emotions short form (8a)(Baseline, 30 days)
- Change in stress as assessed by the Perceived Stress Scale (PSS)(Baseline, 30 days)
- Change in Anxiety as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Global-29 profile(Baseline, 30 days)
- Change in Anxiety as assessed by the PROMIS anxiety computer adaptive testing (CAT)(Baseline, 30 days)
- Change in Physical Function as assessed by the PROMIS Global-29 profile(Baseline, 30 days)
- Change in Self-Efficacy for managing symptoms as assessed by the PROMIS self-efficacy for managing symptoms short form (8a)(Baseline, 30 days)