NCT07154251招募中不适用
Utilizing a Community Health Worker in the Role of a Diabetes Technology Coach for Black Children Using Automated Insulin Delivery and Not Meeting Glycemic Targets (CHWs AID Youth)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in capillary HbA1c
研究概览
简要总结
This study uses community health workers (CHW) as diabetes technology coaches for African American children using automated insulin delivery systems but have an HbA1c of 8% or higher. Families will meet with the CHW monthly x 6 months with additional visits as needed. All participants and parents/guardians will fill out questionnaires at the beginning and end of the 6 month intervention in addition to an interview at 6 months. This will be followed by 6 months with no extra help from the CHW, but we will continue to follow CGM and pump download data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported as non-Hispanic Black
- •Clinical diagnosis of type 1 diabetes, requiring treatment with insulin at the time of consent
- •Currently using, or have used within the past 3 months, an automated insulin delivery system (consisting of a continuous glucose monitor and an insulin pump as well as an automated insulin delivery algorithm)
- •Clinical care provided at UH Cleveland Medical Center
- •Has not previously worked with a community health worker for help with diabetes technology
排除标准
- •Clinical diagnosis of Type 2 or monogenic diabetes
- •Completed high school
- •At least 1 parent/guardian or family support person not willing to participate
- •Non-English speaking guardians
- •Has not used automated insulin delivery within the past 3 months
- •Has previously worked with a CHW for help with diabetes technology
- •Custody of children and family services
结局指标
主要结局
Change in capillary HbA1c
时间窗: Baseline, 3 months, 6 months, 9 months, 12 months
Change in number of participants who use an automated insulin delivery system with at least 80% time in automated mode over the past 30 days, as measured by download of data from the automated insulin delivery system
时间窗: Baseline, 3 months, 6 months, 9 months, 12 months
次要结局
- Change in time in range (70-180 mg/dL) as measured by continuous glucose monitoring(Baseline, 3 months, 6 months, 9 months, 12 months)
- Change in time under 70 mg/dL as measured by continuous glucose monitoring(Baseline, 3 months, 6 months, 9 months, 12 months)
- Change in time over 250 mg/dL as measured by continuous glucose monitoring(Baseline, 3 months, 6 months, 9 months, 12 months)
- Change in continuous glucose monitor wear time as measured by continuous glucose monitoring(Baseline, 3 months, 6 months, 9 months, 12 months)
- Change in time in automated mode as measured by automated insulin delivery system(Baseline, 3 months, 6 months, 9 months, 12 months)
- Change in psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents/guardians(Baseline, 6 months)
- Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale(Baseline, 6 months)
- Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy(Baseline, 6 months)
- Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version(Baseline, 6 months)
- Change in medical distrust, as measured by the Group Based Medical Distrust Scale(Baseline, 6 months)
- Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index(Baseline, 6 months)
- Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index(Baseline, 6 months)
- Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale(Baseline, 6 months)
- Change in barriers to technology as measured by Barriers to Technology Checklist(Baseline, 6 months)
- Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version(Baseline, 6 months)
- Change in Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale(Baseline, 6 months)
- Episodes of Diabetic Ketoacidosis as measured by chart review(up to 12 months)
- Episodes of severe hypoglycemia as measured by chart review(Up to 12 months)
研究者
Sarah A. MacLeish
Associate Professor of Pediatrics
University Hospitals Cleveland Medical Center
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Community Health Workers and Diabetes EducationDiabetesNCT02811874Hospital de Clinicas de Porto Alegre118
已完成
不适用
Community Health Worker Diabetes Prevention InterventionDiabetes PreventionNCT03530579NYU Langone Health954
已完成
不适用
Integrating Community Health Workers to Improve Diabetes PreventionDiabetes MellitusNCT03006666NYU Langone Health773
已完成
不适用
Northern Manhattan Diabetes Community Outreach ProjectDiabetesNCT00787475Columbia University360
Unknown
不适用
Peer-Supported Diabetes Self-Management SupportDiabetesNCT02746861InquisitHealth, Inc.96