Feasibility Studies for Clinical Trials

Children'S Hospital Of Los Angeles, Los Angeles CA

Investigators

Linked publications & trials

Abstract

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.