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

Not Applicable

Completed

• Conditions: Adolescents With Type 2 Diabetes

• Registration Number: NCT00889785
• Lead Sponsor: Vanderbilt University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Study Start: 2009-06
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-16
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 Exclusion criteria:

Patients will be excluded if they meet any of the following:

1. Identify an outside practitioner as the main provider of their child's diabetes care
2. Self report of 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.

Joint Inclusion criteria:

Both the primary caregiver (parent) and adolescent must agree to participate in the research.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
A1C	0,3,6 months
Lipids	0,3,6 months

Secondary Outcome Measures

Name	Time	Method
self-care behaviors	0,3,6 months
blood pressure	0,3,6 months

Trial Locations

Locations (1)

Vanderbilt Univ Medical Center; 🇺🇸 Nashville, Tennessee, United States