Longitudinal test of adherence & control in kids new to T1 diabetes & 5-9 yrs old

纵向依从性测试

• 批准号: 9301535
• 负责人: Susana R Patton
• 金额: $ 35.46万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9301535
• 关键词: 9 year old; Address; Adherence; Adolescence; Adolescent; Affect; Age; Area; Behavior; Behavior Therapy; Behavioral; C-Peptide; Caring; Characteristics; Child; Child Behavior; Child Development; Child Rearing; Childhood; Complications of Diabetes Mellitus; Conflict (Psychology); Data; Development; Diabetes Mellitus; Diagnosis; Disease; Distress; End stage renal failure; Ensure; Failure; Family; Feasibility Studies; Foundations; Fright; Glycosylated hemoglobin A; Goals; Habits; Health; Health behavior; Home environment; Hypoglycemia; Insulin-Dependent Diabetes Mellitus; Intervention; Intervention Studies; Interview; Knowledge; Lead; Learning; Literature; Long-Term Care; Longitudinal Studies; Manuals; Measures; Memory; Mental Depression; Metabolic; Moods; Morbidity - disease rate; Newly Diagnosed; Outcome; Outcome Study; Parents; Patients; Pattern; Phase; Pilot Projects; Preventive Intervention; Preventive treatment; Production; Public Health; Qualitative Research; Recruitment Activity; Regimen; Research; Research Design; Research Methodology; Research Personnel; Risk; Sampling; Schools; Self Care; Series; Stress; Structure; Surveys; Testing; Treatment Protocols; Vascular Diseases; Work; Youth; age group; attentional control; base; behavior influence; cognitive development; coping; data format; design; diabetes management; effective therapy; efficacy trial; executive function; experience; glycemic control; improved; innovation; insulin dependent diabetes mellitus onset; intervention program; lifetime risk; longitudinal design; middle childhood; mortality; novel; polypeptide C; prevent; prospective; prototype; psychologic; public health relevance; theories; therapy design; therapy development

DESCRIPTION (provided by applicant): Children 5-9 years-old and newly diagnosed with type 1 diabetes mellitus (T1DM) have an increased lifetime risk of developing end stage renal disease and poor glycemic control may exacerbate this risk. Our pilot data suggest that up to 44% of 5-9 year-olds new to T1DM experience declining glycemic control early in their disease despite increasing treatment intensification as they exit the honeymoon period. Moreover, from the literature, we can ascertain that these declines may not be solely due to a loss in C peptide production and may be an outcome of nonadherence to daily T1DM management. Targeted behavioral interventions can help patients to achieve better adherence and glycemic control. Unfortunately, no such interventions exist for families of 5-9 year-olds and there is a lack of foundational research to inform intervention development for these families. The PI is a leader in studying T1DM management in young children. With the revised R01, she now seeks to expand her research to focus on intervention development for children in middle childhood. The new R01 aims are to 1) prospectively identify adherence and glycemic trajectories in families of 5-9 year-olds old with new-onset T1DM; 2) identify modifiable parent, child, and family behavior factors that serve as barriers or facilitators of optimal adherence and glycemic trajectories in these families; 3) develop a prototype preventative intervention specifically tailored to these families. The revised R01 aims will be accomplished in two studies. In Study 1, 120 families will complete a 30-month prospective, longitudinal study of adherence and glycemic trajectories and the causes and consequences of these in 5-9 year-olds new to T1DM. In Study 2, 28 parents will participate in serial semi-structured interviews designed to gather new data to inform the content of our preventative intervention and review and refine each intervention module to ensure a high level of acceptability and engagement among families. Finally, 12 families will participate in a pilot feasibility study of the intervention. This R01 is significant because we expect it to produce the necessary data to inform the development of a specific and targeted behavioral intervention which may ultimately result in improved trajectories of glycemic control and adherence for 5-9 year-olds with new-onset T1DM. It is innovative because it proposes a mixed methods research design to efficiently inform our interventions and increase the likelihood our treatments will be targeted to the unique characteristics, needs, and behavioral patterns of 5-9 year-olds with T1DM. We also believe it is innovative in its plan to recruit a homogeneous (by age) sample of children and Study 1's prospective, longitudinal design, which both represent departures from existing research in youths with new-onset T1DM. The research team has complementary expertise in treatment development, longitudinal research, health behavior theories, and T1DM management. The expected outcomes are a relevant and empirically-based preventative treatment, identification of a creditable attention control treatment, and novel longitudinal data regarding health outcomes for 5-9 year-olds with new-onset T1DM.

描述（由申请人提供）：5-9 岁新诊断患有 1 型糖尿病 (T1DM) 的儿童一生中患终末期肾病的风险增加，而血糖控制不佳可能会加剧这种风险。我们的试点数据表明，高达 44% 的 5-9 岁新患 T1DM 的儿童在疾病早期经历了血糖控制下降，尽管在蜜月期结束后加强了治疗强度。此外，从文献中，我们可以确定这些下降可能不仅仅是由于 C 肽产生的损失，而且可能是不遵守日常 T1DM 管理的结果。有针对性的行为干预可以帮助患者实现更好的依从性和血糖控制。不幸的是，目前还没有针对 5-9 岁儿童家庭的此类干预措施，并且缺乏基础研究来为这些家庭制定干预措施提供信息。该 PI 是研究幼儿 T1DM 管理的领导者。通过修订 R01，她现在寻求扩大研究范围，重点关注儿童中期儿童的干预发展。新的 R01 目标是 1) 前瞻性地确定 5-9 岁新发 T1DM 家庭的依从性和血糖轨迹； 2) 确定可改变的父母、儿童和家庭行为因素，这些因素是这些家庭中最佳依从性和血糖轨迹的障碍或促进因素； 3) 开发专门针对这些家庭的预防性干预原型。修订后的 R01 目标将通过两项研究来实现。在研究 1 中，120 个家庭将完成一项为期 30 个月的前瞻性纵向研究，研究 5-9 岁 1 型糖尿病新患者的依从性和血糖轨迹及其原因和后果。在研究 2 中，28 名家长将参加系列半结构化访谈，旨在收集新数据以告知我们预防性干预的内容，并审查和完善每个干预模块，以确保家庭的高水平接受度和参与度。最后，12 个家庭将参与干预措施的试点可行性研究。该 R01 非常重要，因为我们期望它能够产生必要的数据，为制定具体的、有针对性的行为干预措施提供信息，这可能最终改善 5-9 岁新发 T1DM 儿童的血糖控制和依从性轨迹。它具有创新性，因为它提出了一种混合方法研究设计，可以有效地为我们的干预措施提供信息，并增加我们的治疗针对 5-9 岁 1 型糖尿病患者的独特特征、需求和行为模式的可能性。我们还认为，招募同质（按年龄）儿童样本的计划以及研究 1 的前瞻性纵向设计都是创新的，这两者都代表了对新发 T1DM 青少年的现有研究的背离。研究团队在治疗开发、纵向研究、健康行为理论和 T1DM 管理方面拥有互补的专业知识。预期结果是相关且基于经验的预防性治疗、确定可信的注意力控制治疗以及有关 5-9 岁新发 T1DM 儿童健康结果的新颖纵向数据。