Clinical trial NCT02874612: Psychosocial Functioning in Young Adults With Type 1 Diabetes
Official title: Young Adults With Type 1 Diabetes: Psychosocial Influences in Heath Outcomes for Young Adults Transitioning to Adult Care Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: Young Adults
Psychosocial Functioning
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Baylor University
name: Children's National Research Institute
name: Texas A&M University
First posted: 2016-08-22
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All YA (ages 18-24) who are seen in the CCHMC Diabetes Clinic and have recently (\< 4 months) completed the READdY assessment tool as part of their standard clinical care is eligible for the study. In addition, the YA will need to be planning to stay at CCHMC (i.e., not imminently being transferring their diabetes care to an adult provider) for the next 12 months.

Brief summary: Background: The often studied psychosocial correlates that relate to health outcomes in adolescents with Type 1 Diabetes (T1D) are factors such as self-efficacy, depression, distress, quality of life, and adherence. These psychosocial factors are not well-studied within a young adult (YA) population and the parents of YAs during the transition planning phase. Impact: This study aids program development for pre-transfer educational interventions to ensure more successful post-transfer health outcomes from both a patient and parent perspective. Methods: This longitudinal study is designed to characterize the psychosocial factors relevant for a population of YA with T1D. Data analyses of these psychosocial and transition readiness variables allow for understanding of prospective health outcomes for young adults with T1D during the transition process. Implications/Future Directions: From a clinical perspective, the outcomes of this feasibility study will be two-fold: (1) establish which of the clinical measures used in the study are related to meaningful health outcomes in this young adult population in order to determine future standardized assessments in the Diabetes Center and (2) determine which psychosocial constructs are relevant to health outcomes to then more fully develop the Diabetes Center's transition program interventions to improve functioning clinic-wide (e.g., group day sessions). Finally, it would be attractive to various National Institutes of Diabetes and Digestive and Kidney Disorder (NIDDK) grant mechanisms to identify the relevant psychosocial measures that assess the psychosocial functioning of YA with diabetes after they transfer to adult care.

Detailed description: The purpose of this study is to assess how psychosocial functioning and transition readiness (health knowledge and self-reported health-related skills) of young adults (aged 18-24) with Type 1 Diabetes (T1D) and their parents impact health outcomes before they transition to adult diabetes care. Transition of health care from pediatric to adult care systems is a complex process and is often a challenge for young adults. These transition barriers lead to gaps in healthcare, worsening of glycemic control, and increased hospitalizations/emergency room utilization. Initial program development efforts to prepare young adults for transition were developed at Cincinnati Children's Hospital Medical Center (CCHMC) based on best practice recommendations in the literature. The psychosocial correlates of health outcomes in this population are not well studied, though. Nor is it known whether these diabetes education interventions impact transition to adult care over time. The investigators will study how psychosocial factors (e.g., self-efficacy, depression, distress, quality of life, adherence, and risky behaviors) impact health outcomes (e.g., glycemic control) over a one year period, within the context of the current diabetes education transition program at Cincinnati Children's Hospital Medical Center (CCHMC) for young adults with T1D and their parents.

Eligibility criteria: Inclusion Criteria:

* Young Adults ages 18-24
* Current patients of the Cincinnati Children's Hospital Medical Center (CCHMC) Diabetes Clinic
* Recently (\< 4 months) completed the Readiness Assessment tool
* Planning to continue to receive diabetes services at CCHMC (i.e., not imminently being transferring their diabetes care to an adult provider) for the next 12 months.

Exclusion Criteria:

* Co-existing diagnosis of mental retardation or pervasive developmental disorder
* Not fluent in the English language.

Primary outcomes:
measure: Evidence of a correlation between negative diabetes health outcomes and psychosocial functioning over a 1 year period
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants rating themselves as having diabetes resilience as assessed by the Diabetes Resilience Measure (DRMY-YA) measure
timeFrame: 1 year
measure: Number of participating rating themselves as having diabetes quality of life as assessed by the PedsQL Diabetes 3.2 measure
timeFrame: 1 year
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jessica C Kichler, PhD
role: PRINCIPAL_INVESTIGATOR
References: