Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing a Randomized Controlled Trial (RCT)
NCT ID: NCT00889785
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
43 participants
INTERVENTIONAL
2009-06-30
2011-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1 (Usual Care)
Patients will continue to review usual care in the diabetes clinic. Patients will receive monthly phone calls as an active control condition.
Usual Care
Will receive usual care and monthly phone calls as an active control.
Intervention
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Usual Care
Will receive usual care and monthly phone calls as an active control.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
4. unable to access the Internet from any convenient location
5. blind or deaf.
12 Years
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Vanderbilt University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Russell Rothman
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Russell L Rothman, MD MPP
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt Univ Medical Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.