An interventional study of Comprehensive intervention (disease management program) and Usual Care in Adolescents With Type 2 Diabetes, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2013-12-18.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Health services research
The proposed research will test a new comprehensive disease management intervention with adolescents who have type 2 diabetes using a randomized controlled trial (RCT). Adolescents subjects with a history of Type 2 Diabetes and a parent caregiver will be consented, enrolled, and randomly assigned to either an 6-month intervention (N=44) or a "usual care" comparison (N=44). Recruitment will take place within the Vanderbilt Eskind Pediatric Diabetes Clinic. The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component. Outcomes include self-reported self-management behaviors (exercise, diet, medication adherence, etc.), blood pressure, weight/BMI, and glycated hemoglobin (A1C).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 43 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with a diagnosis of T2DM will be included if they are:
Exclusion Criteria:
Patients will be excluded if they meet any of the following:
Parent Inclusion criteria:
Parent Exclusion criteria:
Patients will be excluded if they meet any of the following:
Joint Inclusion criteria:
Both the primary caregiver (parent) and adolescent must agree to participate in the research.
Patients will continue to review usual care in the diabetes clinic. Patients will receive monthly phone calls as an active control condition.
Behavioral: Usual Care
The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component.
Behavioral: Comprehensive intervention (disease management program)
The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component.
Will receive usual care and monthly phone calls as an active control.
A1C
Time frame: 0,3,6 months
Lipids
Time frame: 0,3,6 months
blood pressure
Time frame: 0,3,6 months
self-care behaviors
Time frame: 0,3,6 months
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Vanderbilt University