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: 9910386
• 负责人: DEBORAH A. ELLIS
• 金额: $ 60.59万
• 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/9910386
• 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; Childhood diabetes; Chronic Disease; Clinic; 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; Research; Sampling; Schedule; 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; diabetes self-management; dissemination research; eHealth; effectiveness implementation study; 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; randomized effectiveness trial; recruit; 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.

糖尿病自我管理（DSM）和代谢控制的恶化与青少年相关 发育期是众所周知的。患有1型糖尿病（T1 D）的非洲裔美国青少年 这类问题的风险更高。研究表明，父母的行为，如父母的监督， 青少年完成糖尿病日常护理是青少年DSM的关键预测因素。低水平的父母 监测更有可能导致少数民族或低收入T1 D青年的DSM较差 木屋.很少有针对青少年的研究表明，行为干预可以改善DSM 或者代谢控制，也没有专门针对非裔美国青年的临床试验。此外，委员会认为， 目前还没有针对父母日常监控的干预措施的临床试验发表。 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 在许多行为健康护理领域显示出有希望的效果，也可能增加可及性。 对少数民族家庭进行行为健康干预。我们小组最近进行了一项试验性疗效试验， 测试一个简短的，三个会议，计算机干预，旨在增加父母的监督动机， 监测年轻的照顾者，非洲裔美国青少年谁开始过渡到 独立的自我照顾。虽然干预是为糖尿病诊所的分娩而设计的， 为了我们的疗效试验，它在诊所或家中进行 如果家人错过了预定的诊所预约。疗效研究结果表明， 接受干预的照顾者对他们青少年的日常糖尿病有更高的监测 管理青少年的照顾者接受干预有显着改善， 与对照组相比，代谢控制。拟定研究的目的是进行一项多中心， 对212名患有T1 D的非洲裔美国青少年及其 从美国各地的儿科内分泌诊所招募的主要照顾者。Hybrid 1设计 将被使用，允许提出有关干预措施采用的障碍/促进因素的实施科学问题 真实的世界儿科糖尿病护理诊所有待解决。照顾者-青少年二人组将随机 被分配到两个研究组之一：照顾者动机计算机干预父母监测 糖尿病护理或护理者注意力控制。干预将在三个连续的诊所进行 预约时间超过12个月，但仅在糖尿病诊所进行，以确定 在真实的世界中，干预可以改善DSM和健康结果，有效性条件。剂量效应 和治疗结果的调节剂也将被评估。如果成功，干预有可能 改善健康结果，并促进将行为健康干预纳入日常生活， 为弱势青年群体提供医疗服务。