Feasibility Studies for Clinical Trials

临床试验的可行性研究

• 批准号: 8251834
• 负责人: Yang Lu
• 金额: $ 9.57万
• 依托单位: CHILDREN'S HOSPITAL OF LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-15 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8251834
• 关键词: 18 year old; 20 year old; Accident and Emergency department; Adherence; Adolescence; Adolescent; Age; Alcohol abuse; Behavior; Blindness; Blood Glucose; Blood Vessels; Cataract; Characteristics; Childhood; Chronic Disease; Clinic; Clinical; Clinical Data; Clinical Trials; Communication; Complications of Diabetes Mellitus; Coronary; Data; Data Analyses; Diabetes Mellitus; Diabetic Ketoacidosis; Diagnosis; Disease; Disease Management; Eligibility Determination; Endocrinology; Eye diseases; Feasibility Studies; Friends; Future; Glaucoma; Glycosylated hemoglobin A; Goals; Health; Health Care Costs; Hospitalization; Individual; Infusion procedures; Insulin; Insulin-Dependent Diabetes Mellitus; Kidney; Kidney Diseases; Literature; Location; Los Angeles; Medical; Medical Records; Mental disorders; Mentors; Mentorship; Monitor; Nature; Nerve; Neuropathy; Outcome; Participant; Patients; Peripheral; Phase; Process; Randomized Clinical Trials; Recording of previous events; Recruitment Activity; Research; Retinal Diseases; Risk; Role; Sample Size; Secondary to; Self Management; Socioeconomic Status; Source; Surveys; Time; Training Programs; Treatment Protocols; United States; Visit; Youth; age group; demographics; disorder control; empowered; empowerment; experience; field survey; fighting; glycemic control; illness length; improved; information gathering; interest; malignant breast neoplasm; novel; peer; preference; programs; residence; response; social; subcutaneous; treatment adherence; young adult

DESCRIPTION (provided by applicant): Treatment regimen non-adherence is prevalent among adolescent and young adult patients with Type 1 Diabetes (T1D), which directly contributes to poor glycemic control, faster progression to secondary complications, higher healthcare costs, and shorter survivals. This R03 study will provide preliminary data on the feasibility of peer mentoring to improve adherence in T1D patients in adolescence and young adulthood. Current literature and our previous research suggest that lack of empowerment is a significant barrier to adherence among these age groups. We expect that having young adult patients (19-26 years old) mentor adolescent patients (13-18 years old) on the subject of self-management will empower both groups, leading to improved adherence and better health outcomes. This type of peer mentorship is novel to T1D disease management but has been proven effective in other fields such as alcohol abuse reduction where individuals also need to constantly monitor their behaviors. The study will first develop surveys to gather information from potential T1D mentees and mentors on the feasibility of peer mentoring. For potential mentees, the survey will further identify barriers to adherence, assess the need for and interest in patient-to-patient mentoring, and collect data on patient demographics, disease history, baseline HbA1c levels, strategies for treatment adherence, and preferred modes of mentoring communication. For potential mentors, in addition to what is asked in the mentee survey, input will also be sought on experience of and barriers to adherence, responsiveness to assuming a mentoring role, and aspects of mentor eligibility. 70 potential mentee patients and 30 potential mentor patients will be surveyed and recruited from two pediatric endocrinology clinics in Los Angeles and the ongoing Helmsley T1D Transition "Let's Empower and Prepare" (LEAP) Program (2010PG- T1D011). Clinical data, such as HbA1c, will also be collected from participants' medical records. Quantitative, qualitative, and spatial data analyses will be conducted on the preliminary data collected: (1) contents from the surveys and clinical data will be analyzed and response rates calculated for both groups; (2) baseline HbA1c stratified by patient characteristics will be used for estimating statistical power and planning sufficient sample sizes for a future clinical trial; (3) essential components of a mentor training program wil be discussed and delineated; (4) participants' residential information will be taken into consideration in the process of peer mentorship planning. In summary, this study will assess and evaluate the feasibility of peer mentoring for T1D patients in adolescence and young adulthood, with the goal to improve self-management and glycemic control, and to delay and ameliorate T1D-related complications. This feasibility study will lay the groundwork for a future randomized clinical trial in T1D adherence improvement. PUBLIC HEALTH RELEVANCE: Type 1 Diabetes (T1D) is the second most prevalent serious childhood illness in the United States. Due to T1D's insulin-dependent nature, optimal disease management and glycemic control is largely determined by how well patients adhere to their individual treatment regimen. This feasibility study will provide preliminary data for a future randomized clinical trial of peer mentoring to improve adherence among adolescents and young adults with T1D.

描述（由申请人提供）：不遵守治疗方案在 1 型糖尿病 (T1D) 青少年和年轻成年患者中普遍存在，这直接导致血糖控制不佳、更快进展为继发性并发症、更高的医疗费用和更短的生存期。这项 R03 研究将提供关于同伴指导的可行性的初步数据，以提高青春期和成年早期 T1D 患者的依从性。当前的文献和我们之前的研究表明，缺乏赋权是这些年龄组坚持的一个重大障碍。我们预计，让年轻成年患者（19-26 岁）在自我管理方面指导青少年患者（13-18 岁）将为这两个群体赋权，从而提高依从性并改善健康结果。这种类型的同伴指导对于 T1D 疾病管理来说是新颖的，但在其他领域已被证明是有效的，例如减少酗酒，在这些领域中，个人也需要不断监控自己的行为。该研究将首先开展调查，从潜在的 T1D 受训者和导师那里收集有关同伴指导可行性的信息。对于潜在的受指导者，该调查将进一步确定依从性的障碍，评估患者对患者指导的需求和兴趣，并收集有关患者人口统计、疾病史、基线 HbA1c 水平、治疗依从性策略和首选治疗模式的数据。辅导沟通。对于潜在的导师，除了学员调查中提出的问题外，还将寻求关于依从性的经验和障碍、承担导师角色的反应性以及导师资格方面的意见。将从洛杉矶的两个儿科内分泌诊所和正在进行的赫尔姆斯利 T1D 过渡“让我们赋权和准备”(LEAP) 计划 (2010PG-T1D011) 调查和招募 70 名潜在受训患者和 30 名潜在导师患者。 HbA1c 等临床数据也将从参与者的医疗记录中收集。对收集到的初步数据进行定量、定性和空间数据分析：（1）分析调查内容和临床数据，计算两组的应答率； (2) 按患者特征分层的基线 HbA1c 将用于估计统计功效并为未来的临床试验规划足够的样本量； (3) 讨论和界定导师培训计划的基本组成部分； (4) 在同伴指导规划过程中将考虑参与者的居住信息。总之，本研究将评估青春期和成年早期 T1D 患者同伴辅导的可行性，目的是改善自我管理和血糖控制，延缓和改善 T1D 相关并发症。这项可行性研究将为未来改善 T1D 依从性的随机临床试验奠定基础。 公共卫生相关性：1 型糖尿病 (T1D) 是美国第二大常见的严重儿童疾病。由于 T1D 具有胰岛素依赖性，最佳的疾病管理和血糖控制在很大程度上取决于患者对其个人治疗方案的坚持程度。这项可行性研究将为未来的同伴指导随机临床试验提供初步数据，以提高患有 T1D 的青少年和年轻人的依从性。