The Mindful Kidney: A Digital Mindfulness Intervention for Adults With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Mindfulness App Engagement
研究概览
简要总结
This study tests a digital mindfulness app called Calm Health among adults with chronic kidney disease (CKD). Participants will use the app for 6 weeks while wearing a wrist sensor that tracks sleep, physical activity, heart rate, and other health signals. The study will measure how acceptable and feasible the app is, and whether it may improve stress, anxiety, and quality of life. Participants will also receive health coaching and a personalized report showing how their mindfulness practice relates to their health data.
详细描述
Chronic kidney disease (CKD) affects approximately 15% of U.S. adults and is associated with elevated rates of anxiety, depression, and diminished quality of life. Mindfulness-based interventions have demonstrated efficacy for psychological well-being in chronic illness populations, but scalable digital delivery models for CKD have not been adequately tested.
This single-arm pilot feasibility trial evaluates Calm Health, a HIPAA-compliant digital mindfulness platform, among adults with CKD receiving nephrology care at Yale Medicine or Yale New Haven Hospital. Over 6 weeks, participants will use the app at a recommended dose of 45 minutes per week. They will also wear an Actigraph Leap 2 wrist sensor continuously to capture physical activity, sleep, heart rate, heart rate variability, respiratory rate, skin temperature, and blood pressure trends derived from photoplethysmography (PPG).
The primary objectives are to assess feasibility (app engagement minutes per week) and acceptability (satisfaction, appropriateness, and feasibility ratings). Secondary objectives include estimating pre-post effect sizes for mindfulness (FFMQ), self-compassion (SCS), self-efficacy (CDSES), resilience (BRS), perceived stress (PSS-10), kidney disease quality of life (KDQOL-36), and well-being (SWEMWBS). A third objective evaluates participant response to a personalized biometric report integrating app usage, actigraphy, and PPG-derived blood pressure trends, assessed via cognitive interviewing at the final visit.
Two structured health coaching check-ins are delivered by a qualified allied health professional - one at Week 1 (troubleshooting and onboarding) and one at Week 4 (motivational interviewing approach). Safety monitoring includes GAD-7 and PHQ-8 administered via the Calm Health app at 4 weeks, with structured follow-up protocols for severe or worsening scores. All study visits are conducted via televideo (Zoom).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years
- •Diagnosed with chronic kidney disease (CKD) for at least 6 months with at least two consecutive nephrology visits within the past year
- •Receiving CKD care at Yale Medicine Nephrology or Yale New Haven Hospital
- •Able to use a smartphone (study team will provide one if needed)
- •Able to read and write English
排除标准
- •Current meditation or mindfulness practice meeting or exceeding 70 minutes per week over the past month
- •New or unstable psychopharmaceutical treatment in the past 2 months (stable maintenance therapy with no dose or medication changes for 8 or more weeks is acceptable)
- •Current intensive psychiatric treatment, defined as psychiatric hospitalization in the past 6 months, intensive outpatient program, or inpatient rehabilitation
- •Current or planned pregnancy in the next 6 months
- •Average resting blood pressure exceeding 160/100 mmHg based on readings available in the medical record, with reconfirmation by additional readings prior to exclusion if only an isolated reading in this range is available
研究组 & 干预措施
Intervention
干预措施: Mindfulness (Behavioral)
结局指标
主要结局
Mindfulness App Engagement
时间窗: 6 weeks
Mean minutes per week of Calm Health app use, measured objectively via app backend usage logs across the 6-week intervention period. Feasibility is defined a priori as average engagement ≥45 minutes per week. There is no scale; outcome is reported as continuous minutes per week.
次要结局
- Perceived Stress Scale (PSS-10) Score(Baseline and 6 weeks)
研究者
Garrett I Ash, PhD
Assistant Professor of Medicine, Biomedical Informatics, and Data Science
Yale University