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Completed

NCT Number: NCT00889785

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

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Key information

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt Univ Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comprehensive intervention (disease management program)

Behavioral

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

Behavioral

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

Primary outcomes

  1. A1C

    Time frame: 0,3,6 months

  2. Lipids

    Time frame: 0,3,6 months

Secondary outcomes

  1. blood pressure

    Time frame: 0,3,6 months

  2. self-care behaviors

    Time frame: 0,3,6 months

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

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

Registry information

Official study title

Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing an RCT

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 29, 2009
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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