Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing an RCT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vanderbilt University
- Enrollment
- 43
- Locations
- 2
- Primary Endpoint
- A1C
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
A1C
Time Frame: 0,3,6 months
Lipids
Time Frame: 0,3,6 months
Secondary Outcomes
- self-care behaviors(0,3,6 months)
- blood pressure(0,3,6 months)
Investigators
Russell Rothman
Associate Professor
Vanderbilt University