Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth

支持少数民族青少年糖尿病护理的电子健康干预措施的有效性试验

• 批准号: 9309224
• 负责人: DEBORAH A. ELLIS
• 金额: $ 61.64万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9309224
• 关键词: 14 year old; Address; Adolescence; Adolescent; Adoption; Affect; African American; Appointment; Appointments and Schedules; Area; Behavior Therapy; Behavioral; Caregivers; Caring; Child; Child Rearing; Childhood; Chronic Disease; Clinic; Clinical; Clinical Trials; Complications of Diabetes Mellitus; Computer software; Computers; Conflict (Psychology); Critical Care; Data; Deterioration; Development; Diabetes Mellitus; Dose; Effectiveness; Endocrinology; Family; Glycosylated hemoglobin A; Goals; Health; Healthcare; Healthcare Systems; Home environment; Hybrids; Insulin-Dependent Diabetes Mellitus; Intervention; Intervention Trial; Low income; Medical; Metabolic Control; Minority; Monitor; Motivation; Multicenter Trials; Outcome; Parents; Policies; Procedures; Publishing; Randomized; Randomized Clinical Trials; Recruitment Activity; Research; Sampling; Schedule; Self Management; Single Parent; Supervision; Testing; Treatment Efficacy; Treatment outcome; United States; Use Effectiveness; Vulnerable Populations; Work; Youth; aged; attentional control; base; behavioral health; behavioral health intervention; brief intervention; child depression; clinically significant; cost; design; diabetes education; diabetes management; dissemination research; eHealth; effectiveness trial; efficacy study; efficacy trial; evidence base; executive function; follow-up; high risk; implementation research; implementation science; improved; improved outcome; independent self care; innovation; intervention effect; medical appointment; motivational enhancement therapy; motivational intervention; operation; parental monitoring; primary caregiver; research data dissemination; satisfaction; successful intervention; tool; two-arm study

The deterioration in diabetes self-management (DSM) and metabolic control associated with the adolescent developmental period is well known. African American adolescents with Type 1 diabetes (T1D) are at even higher risk for such problems. Research has shown that parenting behaviors such as parental monitoring of adolescent completion of daily diabetes care are critical predictors of youth DSM. Low levels of parental monitoring are even more likely to result in poor DSM among youth with T1D from minority or low income homes. Few studies targeting adolescents have demonstrated that behavioral interventions can improve DSM or metabolic control, and no clinical trials have focused exclusively on African American youth. Furthermore, there have been no published clinical trials of interventions that have targeted parental monitoring of daily diabetes care as a means of improving DSM in adolescents. Computer-delivered, brief interventions have shown promising effects in a number of areas of behavioral health care and may also increase the accessibility of behavioral health interventions to minority families. Our group has recently conducted a pilot efficacy trial to test a brief, three session, computer intervention aimed at increasing parental motivation for supervision and monitoring among caregivers of young, African American adolescents who are beginning to transition to independent self-care. Although the intervention was designed for delivery in diabetes clinics at regularly scheduled appointments, for the purpose of our efficacy pilot, it was delivered either in the clinic or in the home if the family missed their scheduled clinic appointment. Results from the efficacy study suggested that caregivers who received the intervention had significantly higher monitoring of their adolescent’s daily diabetes management. Adolescents whose caregivers received the intervention had significant improvements in metabolic control compared to controls. The purpose of the proposed study is to conduct a multicenter, randomized effectiveness trial of the intervention with 212 African American adolescents with T1D and their primary caregivers recruited from pediatric endocrinology clinics across the United States. A Hybrid 1 design will be used, allowing implementation science questions about barriers/facilitators to intervention adoption in real world pediatric diabetes care clinics to be addressed. Caregiver-adolescent dyads will be randomly assigned to one of two study arms: caregiver motivational computer intervention for parental monitoring of diabetes care or caregiver attention control. The intervention will be delivered at three consecutive clinic appointments occurring over 12 months but will only be delivered in the diabetes clinic to determine if the intervention can improve DSM and health outcomes under real world, effectiveness conditions. Dose effects and moderators of treatment outcomes will also be evaluated. If successful, the intervention has the potential to improve health outcomes and to contribute to the integration of behavioral health interventions into routine medical care in a vulnerable population of youth.

与青少年相关的糖尿病自我管理（DSM）和代谢控制恶化 发育期是众所周知的。患有 1 型糖尿病 (T1D) 的非洲裔美国青少年的比例持平 此类问题的风险更高。研究表明，父母的养育行为，例如父母的监督 青少年完成日常糖尿病护理是青少年 DSM 的关键预测因素。父母亲水平低 监测更有可能导致少数族裔或低收入患有 T1D 的青少年 DSM 不佳 家园。很少有针对青少年的研究表明行为干预可以改善 DSM 或代谢控制，并且没有专门针对非裔美国青年的临床试验。此外， 目前还没有发表针对家长日常监测的干预措施的临床试验。 糖尿病护理作为改善青少年 DSM 的一种手段。计算机提供的简短干预措施 在行为保健的许多领域显示出有希望的效果，并且还可能增加可及性 对少数族裔家庭的行为健康干预。我们小组最近进行了一项试点功效试验 测试一个简短的、三个阶段的计算机干预，旨在提高家长监督和监督的积极性 对开始过渡到非裔美国青少年的照顾者进行监测 独立自理。尽管该干预措施旨在定期在糖尿病诊所提供 预定的预约，出于我们功效试点的目的，它是在诊所或家里进行的 如果家人错过了预定的诊所预约。功效研究的结果表明 接受干预的护理人员对青少年日常糖尿病的监测明显更高 管理。照顾者接受干预的青少年在以下方面有显着改善： 与对照组相比，代谢控制。拟议研究的目的是进行多中心、 对 212 名患有 T1D 的非洲裔美国青少年及其他们的干预措施进行的随机有效性试验 从美国各地的儿科内分泌诊所招募的主要护理人员。混合 1 设计 将使用，允许实施有关干预措施采用的障碍/促进因素的科学问题 现实世界的儿科糖尿病护理诊所需要解决。照顾者-青少年二人组将是随机的 分配给两个研究组之一：看护者动机性计算机干预，用于家长监控 糖尿病护理或护理人员注意力控制。干预措施将在连续三个诊所进行 预约时间超过 12 个月，但只会在糖尿病诊所进行，以确定是否 干预可以在现实世界的有效性条件下改善 DSM 和健康结果。剂量效应 治疗结果的调节因素也将得到评估。如果成功，干预措施有可能 改善健康结果并促进将行为健康干预措施纳入日常生活 弱势青年群体的医疗服务。