Optimizing Self-Management Adherence and Glycemic Control in Older Teens with T1D

优化老年 T1D 青少年的自我管理依从性和血糖控制

• 批准号: 8518320
• 负责人: Barbara Jane Anderson
• 金额: $ 68.03万
• 依托单位: JOSLIN DIABETES CENTER
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8518320
• 关键词: 17 year old; Adherence; Adolescence; Adult; Affect; Age; Behavior; Behavior Therapy; Behavioral; Blindness; Blood Glucose; Caring; Cellular Phone; Child; Childhood; Chronic; Clinic; Clinic Visits; Comorbidity; Complex; Complications of Diabetes Mellitus; Conflict (Psychology); Data; Deterioration; Development; Diabetes Mellitus; Diagnosis; Eating Disorders; Ensure; Evidence based intervention; Family; Family Study; Frequencies; Genetic Crossing Over; Glycosylated hemoglobin A; Health; Health Care Costs; Healthcare Systems; Heart Diseases; Insulin-Dependent Diabetes Mellitus; Intervention; Kidney Failure; Life Expectancy; Longitudinal Studies; Measures; Morbidity - disease rate; Nature; Outcome; Parents; Participant; Patients; Pharmaceutical Preparations; Population; Populations at Risk; Premature Mortality; Public Health; Quality of life; Randomized; Randomized Controlled Clinical Trials; Risk; Risk Factors; School-Age Population; Self Care; Self Efficacy; Self Management; Series; Staging; Technology; Teenagers; Text; Therapeutic; Vulnerable Populations; Work; Youth; adverse outcome; base; blood glucose regulation; clinical research site; cost; cost effective; depressive symptoms; design; diabetes management; disability; early onset; experience; follow-up; glucose monitor; glycemic control; group intervention; high risk; improved; independent self care; indexing; middle age; multi-component intervention; peer; prevent; primary outcome; psychologic; satisfaction; social cognitive theory; standard care; uptake; young adult

DESCRIPTION (provided by applicant): Despite many new medications and technologies to improve diabetes self-management and glycemic control (blood glucose [BG] levels), disability and premature mortality from chronic diabetes complications remain common, highlighting the gap between treatment advances and robust patient uptake. Non-adherence to prescribed diabetes treatment contributes significantly to this gap, especially in the vulnerable population o mid to older teens with type 1 diabetes (T1D) who are emerging from their parents' care and becoming more independent in their own self-care. During this developmental period, glycemic control often deteriorates as adherence to BG monitoring declines. Longitudinal studies reveal that non-adherence in late adolescence is a risk factor for poor glycemic control, multiple physical and psychiatric comorbidities, and premature mortality. The primary aim of the proposed project is to improve glycemic control, measured as hemoglobin A1c (A1c) (an index of average BG levels over the previous 2-3 months), by motivating self-care behaviors in mid to older teens with T1D, ages 14-17 years old. Given the complex and often intractable nature of non- adherence in adolescence, this application proposes to design, implement, and evaluate multi-faceted interventions aimed at increasing adherence, particularly to BG monitoring, and improving glycemic control. These interventions include: (1) a behavioral Teen work (TW) intervention targeting BG monitoring and diabetes self-management through increased self-efficacy, (2) automated 2-way text message reminders to check BG levels (TX), or (3) both (TW/TX). The proposed project extends our Family Teamwork intervention, previously validated in school-age children and young teens with T1D, by tailoring it to mid to older teens with T1D, and also builds on our pilot work of 2-way text message reminders to increase BG monitoring frequency. The Teen work intervention is focused on self-care behaviors and is integrated into the teen's regular quarterly diabetes clinic visits. Grounded in social cognitive theory, this multiple-PI R01 randomized controlled clinical trial will be implemented at 2 large diabetes clinical sites. We propose a 2x2 factorial design in which 300 mid to older teens with T1D duration of e1 year and A1c levels of 7-13% will be randomized to 1 of 4 groups: TW, TX, TW/TX, or Standard Care (SC). In this 2-year study, the primary outcome will be change in A1c from baseline to 12 months across the 4 groups, as well as from 12 to 24 months. To ensure recruitment and retention of this at-risk population, the SC group will cross-over to TW/TX at 12 months. The TW, TX, and TW/TX groups will continue to receive their respective interventions in months 12-24 to assess durability. We will assess BG monitoring frequency and A1C, as well as other measures for mode rational and meditational analyses. Data will be collected on costs of the interventions and any adverse outcomes to assess if the interventions enhance adherence to BG monitoring and improve A1c cost-effectively in mid to older teens with T1D as they prepare to transition to young adulthood and diabetes self-care.

描述（由申请人提供）：尽管有许多新的药物和技术可以改善糖尿病的自我管理和血糖控制（血糖 [BG] 水平），但慢性糖尿病并发症导致的残疾和过早死亡仍然很常见，突显了治疗进展与患者积极接受之间的差距。不遵守规定的糖尿病治疗在很大程度上造成了这一差距，特别是在弱势群体中，尤其是患有 1 型糖尿病 (T1D) 的中老年青少年中，他们正在摆脱父母的照顾，并在自我护理方面变得更加独立。在这个发育时期，血糖控制往往会随着血糖监测依从性的下降而恶化。纵向研究表明，青春期后期的不依从性是血糖控制不佳、多种身体和精神合并症以及过早死亡的危险因素。该项目的主要目标是通过激励 14-17 岁中老年 T1D 青少年的自我护理行为，改善血糖控制，以血红蛋白 A1c (A1c)（过去 2-3 个月平均血糖水平的指数）来衡量。鉴于青春期不依从性的复杂性和往往棘手的性质，本申请建议设计、实施和评估旨在提高依从性的多方面干预措施，特别是血糖监测和改善血糖控制。这些干预措施包括：(1) 行为青少年工作 (TW) 干预措施，旨在通过提高自我效能来进行血糖监测和糖尿病自我管理，(2) 自动双向短信提醒以检查血糖水平 (TX)，或 (3) 两者兼而有之 (TW/TX)。拟议的项目扩展了我们之前在患有 T1D 的学龄儿童和青少年中验证的家庭团队合作干预措施，将其针对中老年 T1D 青少年进行了定制，并且还建立在我们的双向短信提醒试点工作的基础上，以提高 BG 监测频率。青少年工作干预的重点是自我护理行为，并纳入青少年每季度定期就诊的糖尿病诊所。这项多PI R01随机对照临床试验以社会认知理论为基础，将在2个大型糖尿病临床中心实施。我们提出了 2x2 因子设计，其中 300 名 1D 病程为 e1 年且 A1c 水平为 7-13% 的中老年青少年将被随机分入 4 组中的一组：TW、TX、TW/TX 或标准护理 (SC)。在这项为期 2 年的研究中，主要结果是 4 组的 A1c 从基线到 12 个月以及 12 到 24 个月的变化。为了确保招募和保留这一高危人群，SC 组将在 12 个月时交叉到 TW/TX。 TW、TX 和 TW/TX 组将在第 12-24 个月继续接受各自的干预措施，以评估耐久性。我们将评估 BG 监测频率和 A1C，以及用于模式理性和冥想分析的其他措施。将收集有关干预措施成本和任何不良后果的数据，以评估干预措施是否可以增强 BG 监测的依从性，并在中老年 1D 青少年准备过渡到青年期和糖尿病自我护理时经济有效地改善 A1c。