Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care

NCT01109797 | Completed

• 1 other identifier: 12157
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare two interventions for preparing diabetic teens and young adults for transition from pediatric to adult diabetes care.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Measure and compare change in self-efficacy and change in diabetes knowledge, diabetes quality of life, family conflict, and treatment satisfaction for and between the two groups.

  6 months and 12 months

Secondary Outcomes (4)

• Make exploratory baseline comparisons between the two groups regarding locus of diabetes care (kind of provider), comparing numbers of subjects in each group who made a successful transition to adult care

  6 months and 12 months

• Make exploratory baseline comparisons between the two groups of using some form of social networking by the two groups as an adjunt of diabetes care.

  6 months and 12 months

• Make exploratory baseline comparisons between the two groups regarding provider and educator time devoted in each arm of the intervention (in order to prepare for a robust comparative effectiveness analysis in a subsequent study).

  6 months

• Make exploratory baseline comparisons between the two groups of HgbA1c

  6 months and 12 months

Study Arms (2)

Transition Social Behavioral Intervention

EXPERIMENTAL

Behavioral: Transition Social Behavioral Intervention

Diabetes Transition Clinic

EXPERIMENTAL

Behavioral: Diabetes Transition Clinic

Interventions

Transition Social Behavioral Intervention BEHAVIORAL

If you are assigned to the first group, you will have two all-day Saturday sessions four weeks apart on the KU campus in Lawrence. The objectives of the Saturday programs are to promote positive behavior change with respect to "taking ownership" of diabetes and its demands by providing transition-specific information, enabling participants to practice the life skills needed to successfully manage diabetes as an adult, and fostering peer-to-peer social networking over the 6-month period of the intervention (and beyond). You will continue to see your current provider of diabetes care outside of the parameters of this study.

Transition Social Behavioral Intervention

Diabetes Transition Clinic BEHAVIORAL

Patients who participate in the transition clinic arm of the study will be seen six times during a six-month time period, as well as receive psychological assessment and intervention, as necessary, prior to the first clinic visit (intake) and as part of visits 2 and 4. Three of the six visits will be standard of care medical visits with either a pediatric or adult provider or both. Three will be individual or group education sessions with diabetes educators focused on transition issues such as, managing the adult health care system, talking with your care provider,and dealing with adult issues (pregnancy, genetic concerns, etc).

Diabetes Transition Clinic

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 16-29
• Diagnosis of type 1 diabetes, or type 2 diabetes managed with insulin, at least one year prior to study initiation
• English-speaking
• Some form of private or public (e.g., Medicaid) health insurance

You may not qualify if:

• Cystic fibrosis-related or pancreatitis-related diabetes
• Diabetes related to a known specific genetic defect such as Down's Syndrome, Lipoatrophic Diabetes, Leprechaunism or Rabson-Mendenhall Syndrome, etc.
• Chronic liver disease
• History of chronic renal failure
• Serious psychiatric illness that in the judgment of the investigators would preclude the individual's ability to complete the study
• Pregnant or planning to become pregnant within 6 months

Sponsors & Collaborators

• University of Kansas: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kurt Midyett, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 23, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 26, 2014

Record last verified: 2014-05

Locations

US (1)