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

Primary Purpose

Adolescents With Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive intervention (disease management program)
Usual Care
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adolescents With Type 2 Diabetes focused on measuring Adolescents, Type 2 Diabetes, Behavioral Research

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Vanderbilt Univ Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1 (Usual Care)

Intervention

Arm Description

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

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

Primary Outcome Measures

A1C
Lipids

Secondary Outcome Measures

blood pressure
self-care behaviors

Full Information

First Posted
April 28, 2009
Last Updated
December 16, 2013
Sponsor
Vanderbilt University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00889785
Brief Title
Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing a Randomized Controlled Trial (RCT)
Official Title
Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing an RCT
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescents With Type 2 Diabetes
Keywords
Adolescents, Type 2 Diabetes, Behavioral Research

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 (Usual Care)
Arm Type
Active Comparator
Arm Description
Patients will continue to review usual care in the diabetes clinic. Patients will receive monthly phone calls as an active control condition.
Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive intervention (disease management program)
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Will receive usual care and monthly phone calls as an active control.
Primary Outcome Measure Information:
Title
A1C
Time Frame
0,3,6 months
Title
Lipids
Time Frame
0,3,6 months
Secondary Outcome Measure Information:
Title
blood pressure
Time Frame
0,3,6 months
Title
self-care behaviors
Time Frame
0,3,6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis of T2DM will be included if they are: Age 12-19 years A clinical diagnosis of T2DM (according to the patient and their health provider in the clinic) Actively receive diabetes care in the Eskind Diabetes Clinic Willingness of patient and a caregiver to access the Internet to complete problem solving activities 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: Identify an outside practitioner as the main provider of their diabetes care Have a significant psychiatric illness such as severe depression or active psychosis that would impact on the ability to participate in the study Life expectancy of <6 months Unable to access the Internet from any convenient location Blind or deaf Parent Inclusion criteria: Parents must be a primary caregiver of an adolescent with a diagnosis of T2DM between the ages 12-19 seen at the Eskind Clinic 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: Identify an outside practitioner as the main provider of their child's diabetes care Self report of significant psychiatric illness such as severe depression or active psychosis that would impact on the ability to participate in the study life expectancy of <6 months unable to access the Internet from any convenient location blind or deaf. Joint Inclusion criteria: Both the primary caregiver (parent) and adolescent must agree to participate in the research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell L Rothman, MD MPP
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Univ Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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

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