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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Russell Rothman, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00889785
First received: April 28, 2009
Last updated: December 16, 2013
Last verified: December 2013

April 28, 2009
December 16, 2013
June 2009
August 2011   (final data collection date for primary outcome measure)
  • A1C [ Time Frame: 0,3,6 months ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: 0,3,6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00889785 on ClinicalTrials.gov Archive Site
  • blood pressure [ Time Frame: 0,3,6 months ] [ Designated as safety issue: No ]
  • self-care behaviors [ Time Frame: 0,3,6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing a Randomized Controlled Trial (RCT)
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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Adolescents With Type 2 Diabetes
  • 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.
  • Active Comparator: 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.
    Intervention: Behavioral: Usual Care
  • Experimental: 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.
    Intervention: Behavioral: Comprehensive intervention (disease management program)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
August 2011
August 2011   (final data collection date for primary outcome measure)

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.

Both
12 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00889785
090076, K23 DK065294, R03 DK081726
No
Russell Rothman, Vanderbilt University
Vanderbilt University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Russell L Rothman, MD MPP Vanderbilt University
Vanderbilt University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP