MedTrace Logo

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

NCT00889785 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2013-12-18

No results posted yet for this study

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).

Conditions

  • Adolescents With Type 2 Diabetes

Interventions

BEHAVIORAL

Comprehensive intervention (disease management program)

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.

BEHAVIORAL

Usual Care

Will receive usual care and monthly phone calls as an active control.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Russell L Rothman, MD MPP · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00889785 on ClinicalTrials.gov