Adolescents With Type 2 Diabetes
Conditions
Keywords
Adolescents, Type 2 Diabetes, Behavioral Research
Brief summary
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).
Interventions
BEHAVIORALComprehensive 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.
BEHAVIORALUsual Care
Will receive usual care and monthly phone calls as an active control.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
Patients with a diagnosis of T2DM will be included if they are: 1. Age 12-19 years 2. A clinical diagnosis of T2DM (according to the patient and their health provider in the clinic) 3. Actively receive diabetes care in the Eskind Diabetes Clinic 4. Willingness of patient and a caregiver to access the Internet to complete problem solving activities 5. Adolescent address is the same as their primary caregiver participating in the study
Exclusion criteria
Patients will be excluded if they meet any of the following: 1. Identify an outside practitioner as the main provider of their diabetes care 2. Have a significant psychiatric illness such as severe depression or active psychosis that would impact on the ability to participate in the study 3. Life expectancy of \<6 months 4. Unable to access the Internet from any convenient location 5. Blind or deaf Parent Inclusion criteria: 1. Parents must be a primary caregiver of an adolescent with a diagnosis of T2DM between the ages 12-19 seen at the Eskind Clinic 2. Willingness of patient and a caregiver to access the Internet to complete problem solving activities. Parent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A1C | 0,3,6 months |
| Lipids | 0,3,6 months |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure | 0,3,6 months |
| self-care behaviors | 0,3,6 months |
Countries
United States
Outcome results
None listed