Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing a Randomized Controlled Trial (RCT)

Study Overview
=================
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).

Official Title
-----------------
Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing an RCT

Conditions
-----------------
Adolescents With Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Comprehensive intervention (disease management program)
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 (Usual Care)<br>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<br>* Will receive usual care and monthly phone calls as an active control.<br>|
| Experimental: Intervention<br>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)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1C |  | 0,3,6 months | 
| Lipids |  | 0,3,6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 0,3,6 months | 
| self-care behaviors |  | 0,3,6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescents, Type 2 Diabetes, Behavioral Research