CKD Awareness, Referrals, Education, and Support Intervention for Early-Stage CKD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Motivation for diabetes-related self-care behaviour scale
研究概览
简要总结
The goal of this pilot clinical trial is to learn if an intervention delivering education, motivational support, and social support can prevent worsening kidney disease in adults with diabetes and early-stage kidney disease. The main questions it aims to answer are:
- Is this intervention feasible to deliver and acceptable to patients?
- What is the impact of the intervention on patient motivation, self-efficacy, kidney disease knowledge, and use of support services referrals?
The investigators will compare information collected about participants' response to this intervention with a group of similar patients who receive general diabetes information.
Participants will meet virtually with a nurse approximately 1 week before a scheduled primary care provider visit and complete surveys over the phone three times in a period of three months.
详细描述
Chronic kidney disease (CKD) progression to kidney failure causes devastating declines in quality of life and mortality, with high healthcare costs. CKD affects ~15% of all adults in the U.S. and ~40% of adults with diabetes, with substantial variability in rate of progression to kidney failure. Negative social determinants of health (SDOH), such as food insecurity can speed up disease progression. However, if CKD progression to kidney failure can be prevented or delayed, patients can experience minimal impact on health and well-being. The diagnosis, treatment, and monitoring of early-stage, asymptomatic CKD occurs predominantly in the primary care setting, including for those with diabetes. Unfortunately, the rates of guideline-based CKD care delivery are low, and as a result, clinical diagnosis of early-stage CKD is as low as 50%. Delay in receiving a CKD diagnosis is associated with faster progression to kidney failure. Furthermore, because CKD is not always prioritized in the busy primary care setting, most patients are unaware they have CKD and have low rates of CKD knowledge, which impedes their ability to adhere to treatment. To address the issues of underdiagnosis, patients' lack of disease knowledge and self-efficacy, and the impact of SDOH for patients with diabetes and CKD, proactive action is critical. The investigators will target patients with diabetes who are eligible for an early-stage CKD diagnosis with a nurse-led, pre-primary care-visit 1:1 virtual session including evidence-based CKD education, motivational interviewing, and SDOH screening with referrals to services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •adults (18+)
- •diabetes diagnosis (type 1 or 2)
- •CKD Stage 3 diagnosis eligible
- •>1 prior visit at the UIHealth primary care clinics
- •can speak English
排除标准
- •CKD of congenital or pediatric onset
- •history of kidney transplant
- •cognitive impairment as documented in the medical record
研究组 & 干预措施
Intervention group
Participants will participate in a nurse-led virtual session delivering education about chronic kidney disease, motivational interviewing to set a self-management goal, and screening/referral for social determinants of health barriers to treatment adherence and engagement.
干预措施: CKD Awareness, Referrals, Education, and Support (CARES) (Behavioral)
Control group
The attention control group will participate in a nurse-led virtual session delivering general information about diabetes and treatment.
干预措施: Attention control (Behavioral)
结局指标
主要结局
Motivation for diabetes-related self-care behaviour scale
时间窗: From enrollment to study completion (2-3 months)
Participant self-report. A scale from 1-5, with a lower score meaning not motivated and a higher score meaning highly motivated. Items are different self-management behaviors (e.g., medication, diet, exercise).
Kidney Disease Knowledge Survey
时间窗: From enrollment to study completion (2-3 months)
Participant self-report. A set of fact-based questions about kidney disease which has a right and a wrong answer. Participants will be scored based on % correct answers.
CKD Self Efficacy Instrument
时间窗: From enrollment to study completion (2-3 months)
Participant self-report. The scale ranges from 1-10, with low scores indicating not at all confident and high scores indicating totally confident.
Social referral uptake
时间窗: From enrollment to study completion (2-3 months)
Participant self-report of uptake of any support services for barriers to treatment adherence that are needed.
次要结局
- Brief Illness Perceptions Questionnaire(From enrollment to study completion (2-3 months))
- Patient activation Measure(From enrollment to study completion (2-3 months))
- PROMIS Medication Adherence Scale(From enrollment to study completion (2-3 months))
- Dialysis Diet and Fluid Non-adherence Questionnaire(From enrollment to study completion (2-3 months))
- International Physical Activity Questionnaire(From enrollment to study completion (2-3 months))
- Care plan changes(From enrollment to study completion (2-3 months))
- Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences(From enrollment to study completion (2-3 months))