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



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:12 - 19
Updated:11/30/2013
Start Date:June 2009
Contact:Russell L Rothman, MD MPP
Email:russell.rothman@vanderbilt.edu
Phone:615-936-2149

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


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).


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.
We found this trial at
1
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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