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）：在青少年和年轻的1型糖尿病患者（T1D）中，不遵守治疗方案不遵守，这直接导致血糖控制不良，更快地发展为继发性并发症，更高的医疗保健成本和较短的生存。这项R03研究将提供有关同伴指导以提高青春期和年轻成年患者依从性的可行性的初步数据。当前的文献和以前的研究表明，缺乏赋权是这些年龄段遵守的重大障碍。我们预计，有年轻的成年患者（19-26岁）导师青少年患者（13-18岁）就会受到自我管理的影响，将增强两组的能力，从而提高依从性和改善健康成果。这种类型的同伴指导对T1D疾病管理是新颖的，但已被证明在其他领域（例如减少酗酒的领域）也有效，因为个人也需要不断监测其行为。该研究将首先制定调查，以收集潜在的T1D训练者和导师有关同伴指导的可行性的信息。对于潜在的受训者，该调查将进一步确定遵守障碍，评估对患者到患者指导的需求和兴趣，并收集有关患者人口统计学，疾病史，基线HBA1C水平，治疗依从性的策略以及良好的指导沟通方式的数据。对于潜在的导师，除了在《指导者调查》中所要求的内容外，还将寻求有关依从性的经验和障碍，对指导角色的反应以及导师资格的各个方面的意见。将从洛杉矶的两个小儿内分泌诊所和正在进行的Helmsley T1D转变“让我们的Empower and Progarge and Progarne Program”（2010PG- T1D011）进行调查和招募70名潜在的受训患者和30名潜在的导师患者。 HBA1C等临床数据也将从参与者的病历中收集。将对收集的初步数据进行定量，定性和空间数据分析：（1）将分析调查和临床数据中的内容，并对两组计算出响应率； （2）根据患者特征分层的基线HBA1C将用于估计统计能力和计划以后的临床试验的足够样本量； （3）将讨论和划定导师培训计划的基本组成部分； （4）在同行指导计划的过程中，将考虑参与者的住宅信息。总而言之，这项研究将评估和评估青春期和成年期T1D患者的同伴指导的可行性，以改善自我管理和血糖控制，并延迟和改善与T1D相关的并发症。这项可行性研究将为T1D依从性改善的未来随机临床试验奠定基础。 公共卫生相关性：1型糖尿病（T1D）是美国第二普遍的严重童年疾病。由于T1D的胰岛素依赖性，最佳疾病管理和血糖控制在很大程度上取决于患者遵守其个体治疗方案的能力。这项可行性研究将为未来的同伴指导的随机临床试验提供初步数据，以提高青少年和T1D年轻人的依从性。