Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01109797|
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : May 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Behavioral: Transition Social Behavioral Intervention Behavioral: Diabetes Transition Clinic||Not Applicable|
One will represent a short-term intensive social-behavioral intervention supported by peer-to-peer social networking in which subjects receive "usual care" from their current diabetes provider outside the parameters of the study. The second intervention will be a traditional transition clinic model, where subjects will receive the standard of diabetes care from a team of combined pediatric and adult practitioners and educators, with added educational modules and behavioral evaluation and support designed to facilitate the transition to adult care (i.e., that foster "developmentally tailored care"). The first is a much less intensive intervention from the standpoint of the providers and gives special prominence to peer support; the second is provider-intensive. The goal of both interventions is to improve self-efficacy (confidence in taking ownership of and managing one's diabetes); i.e., to prepare the patient to move from primary support by family and providers to a reliance on self-ownership and self-management as a responsible, independent adult.
Optional sub-study available for parents, spouses, and significant others.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of Two Models for Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
|Experimental: Transition Social Behavioral Intervention||
Behavioral: Transition Social Behavioral Intervention
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.
|Experimental: Diabetes Transition Clinic||
Behavioral: Diabetes Transition Clinic
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).
- 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. [ Time Frame: 6 months and 12 months ]
- 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 [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: 6 months ]
- Make exploratory baseline comparisons between the two groups of HgbA1c [ Time Frame: 6 months and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109797
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Kurt Midyett, MD||University of Kansas Medical Center|