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

Vanderbilt University

Status: Completed

Conditions: Adolescents With Type 2 Diabetes

Treatments: Behavioral: Usual Care; Behavioral: Comprehensive intervention (disease management program)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00889785

R03DK081726 (U.S. NIH Grant/Contract)

090076

K23DK065294 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 43 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No 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

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

43 participants in 2 patient groups

1 (Usual Care)

Active Comparator group

Description:

Patients will continue to review usual care in the diabetes clinic. Patients will receive monthly phone calls as an active control condition.

Treatment:

Behavioral: Usual Care

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Comprehensive intervention (disease management program)