CommunityRx-Kidney Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 634
- 试验地点
- 1
- 主要终点
- Acute healthcare utilization
研究概览
简要总结
In the United States, the burden of chronic kidney disease (CKD) rests disproportionately on rural communities. This study evaluates the implementation and effectiveness of CommunityRx-Kidney Health (CRx-K); this health information technology intervention integrates medical, social, and self-care resources to improve CKD management in rural eastern North Carolina. Through a partnership among local primary care centers, community organizations, and researchers, CRx-K will strengthen rural care networks, improve CKD management, and enhance the well-being of rural communities.
详细描述
Approximately one in seven adults in the United States lives with chronic kidney disease (CKD). CKD typically worsens with time and, in its final stage, can result in kidney failure. Contextual factors in rural, eastern North Carolina communities impede optimal management of CKD multimorbidity. In these communities, geographical barriers to medical care, dwindling resources, and underdeveloped health infrastructure have worsened CKD outcomes. CommunityRx-Kidney Health (CRx-K) is an evidence-based, low-intensity, health information technology-driven intervention designed to support CKD management in rural eastern North Carolina. CRx-K integrates medical (e.g., blood pressure and glucose monitoring, eye and foot care), social (food, housing, transportation), and self-care (weight and stress management, exercise) resources. CRx-K comprises three components: brief education on integrated CKD needs, a personalized community resource referral list (HealtheRx), and clinic navigator-led, longitudinal support (12 months) for CKD patients in our trial. Our multidisciplinary, community-engaged research team will test the effects of CRx-K through three related aims.
This pragmatic individual-randomized, two-arm, single-blind trial in 35 rural primary care clinics in 16 rural eastern North Carolina counties (n=634 adults with CKD) assesses the effect of CRx-K on acute healthcare utilization (primary outcome), self-efficacy for finding resources, knowledge and sharing of integrated care resources, resource use, number of unmet needs over time, ambulatory care utilization, and health-related quality of life. The researchers hypothesize that 12-month acute healthcare utilization will differ between participants receiving CRx-K and those receiving usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
Investigators are masked to participant assignments. Unmasked research staff support enrollment, randomization, and data collection; unmasked navigators deliver the intervention to participants randomized to the active arm. Participant masking is not possible, as participants in the active condition will receive the three CRx-K components described during the consent process.
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
- •Diagnosis of chronic kidney disease defined as ≥1 ICD-10 CKD codes (excluding end-stage kidney disease) or CKD biomarkers (estimated glomerular filtration rate ≤ 60 ml/min, albuminuria ≥30 mg/24h)
- •At least one clinic visit at Goshen Medical Center in 12 months before enrollment
排除标准
- •Limited life expectancy (e.g., advanced cancer, end-stage liver disease, hospice)
- •Active cancer treatment
- •Living in a skilled nursing facility
- •Dementia/other significant cognitive impairment/inability to participate in the informed consent process
研究组 & 干预措施
Intervention + usual care
This arm will receive the intervention in addition to usual care.
干预措施: CommunityRx-Kidney Health (Behavioral)
Usual care only
This arm will not receive the intervention.
结局指标
主要结局
Acute healthcare utilization
时间窗: 12 months
Acute healthcare utilization is measured as the sum of self-reported 911 calls, ambulance visits, emergency room visits, urgent care visits, and hospital admissions across the 12-month follow-up period.
次要结局
- Ambulatory healthcare utilization(12 months)
- Self-efficacy for finding social and self-care resources(6 months, 12 months)
- Attitudes about social and self-care resources(6 months, 12 months)
- Knowledge of social and self-care resources(6 months, 12 months)
- Use of social and self-care resources(6 months, 12 months)
- Unmet social and self-care needs(6 months, 12 months)
- Sharing of information about social and self-care resources(6 months, 12 months)
- Health-related quality of life(6 months, 12 months)