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Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing a Randomized Controlled Trial (RCT) | Clinical Trials | Clareo Health

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

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

NCT00889785•Vanderbilt University

View on ClinicalTrials.gov

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).

Eligibility

Age

12 - 19 years

Sex

ALL

Healthy Volunteers

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

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
•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
+2 more criteria

Locations (1)

Vanderbilt Univ Medical Center

Nashville, Tennessee, United States

Key Dates

Start Date

June 1, 2009

Primary Completion Date

August 1, 2011

Completion Date

August 1, 2011

Last Updated

December 18, 2013

Enrollment

ACTUAL participants

Conditions

Adolescents With Type 2 Diabetes

Interventions

Comprehensive intervention (disease management program)

BEHAVIORAL

Usual Care

BEHAVIORAL