Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing a Randomized Controlled Trial (RCT)
Completed · Not applicable
Conditions studied: Adolescents With Type 2 Diabetes
In brief
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).
Key facts
- Study ID
- NCT00889785
- Run by
- Vanderbilt University
- People needed
- 43
- Starts
- 2009-06-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2013-12-18
Who can join
Age: 12 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with a diagnosis of T2DM will be included if they are:
- Age 12-19 years
- A clinical diagnosis of T2DM (according to the patient and their health provider in the clinic)
- Actively receive diabetes care in the Eskind Diabetes Clinic
- Willingness of patient and a caregiver to access the Internet to complete problem solving activities
- Adolescent address is the same as their primary caregiver participating in the study
You may not qualify if…
- Patients will be excluded if they meet any of the following:
- Identify an outside practitioner as the main provider of their diabetes care
- Have a significant psychiatric illness such as severe depression or active psychosis that would impact on the ability to participate in the study
- Life expectancy of <6 months
- Unable to access the Internet from any convenient location
- Blind or deaf
- Parent Inclusion criteria:
- Parents must be a primary caregiver of an adolescent with a diagnosis of T2DM between the ages 12-19 seen at the Eskind Clinic
- Willingness of patient and a caregiver to access the Internet to complete problem solving activities.
- Parent Exclusion criteria:
- Patients will be excluded if they meet any of the following:
- Identify an outside practitioner as the main provider of their child's diabetes care
- Self report of significant psychiatric illness such as severe depression or active psychosis that would impact on the ability to participate in the study
- life expectancy of <6 months
- unable to access the Internet from any convenient location
- blind or deaf.
- Joint Inclusion criteria:
- Both the primary caregiver (parent) and adolescent must agree to participate in the research.
Where it is running
- Vanderbilt Univ Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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