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
  Purpose

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).


Condition Intervention
Adolescents With Type 2 Diabetes
Behavioral: Comprehensive intervention (disease management program)
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing an RCT

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • A1C [ Time Frame: 0,3,6 months ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: 0,3,6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 43
Study Start Date: June 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Usual Care
Will receive usual care and monthly phone calls as an active control.
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.
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.

  Eligibility

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889785

Locations
United States, Tennessee
Vanderbilt Univ Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Russell L Rothman, MD MPP Vanderbilt University
  More Information

No publications provided

Responsible Party: Russell Rothman, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00889785     History of Changes
Other Study ID Numbers: 090076, K23 DK065294, R03 DK081726
Study First Received: April 28, 2009
Last Updated: December 16, 2013
Health Authority: United States: Independent Data Safety Monitor (Cyndi Lybarger RN CDE)
United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Adolescents
Type 2 Diabetes
Behavioral Research

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 31, 2014