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Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study

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ClinicalTrials.gov Identifier: NCT01892280
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : September 23, 2019
Sponsor:
Collaborators:
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Lori Laffel, Joslin Diabetes Center

Tracking Information
First Submitted Date  ICMJE July 1, 2013
First Posted Date  ICMJE July 4, 2013
Last Update Posted Date September 23, 2019
Study Start Date  ICMJE November 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
Change in glycemic control from baseline to 1 year [ Time Frame: Baseline and 1 year ]
Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01892280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
  • Change in glycemic control from 1 year to 18 months [ Time Frame: 1 year and 18 months ]
    Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)
  • Psychosocial factors (self-report surveys) [ Time Frame: Baseline, 6 months, 1 year, 18 months ]
    We will assess psychosocial factors (e.g., diabetes-specific family conflict, diabetes burden, negative affect around blood glucose monitoring, quality of life, depressive symptoms, self-efficacy, disordered eating behaviors) every 6 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study
Official Title  ICMJE Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study
Brief Summary The purpose of this 18-month randomized controlled trial (RCT) is to find out if (1) a set of psychoeducational materials for teens with type 1 diabetes and (2) text message reminders to check blood glucose levels can help improve blood glucose levels in teens with type 1 diabetes.
Detailed Description

Glycemic control deteriorates during adolescence as parents become less involved in teens' diabetes management and adherence declines. Thus, there is a need to improve adherence and glycemic control in mid to older teens with type 1 diabetes by strengthening the teens' self-efficacy for daily diabetes self-management to help prepare them for the transition between pediatric and adult care. This 18-month, multi-center RCT is designed to increase frequency of blood glucose monitoring and improve glycemic control in teens with type 1 diabetes through a behavioral intervention called Teenwork with or without text message reminders to check blood glucose levels.

We will implement and evaluate the Teenwork intervention and text message reminders to check blood glucose levels in a 2x2 factorial design in which 300 participants, across two sites, will be randomized to 1 of 4 groups: Teenwork, Text Message, Teenwork/Text Message, or Usual Care.

Participants in the Teenwork Group will meet with a research assistant during each study visit to review strategies for improving self-care, including self-management and self-advocacy, focusing on two areas: blood glucose monitoring and insulin administration. Participants in the Text Message Group will be instructed in the use of the text messaging system. They will receive 2-way text message reminders to check blood glucose levels at self-selected times and to reply by text message with blood glucose results. Participants in the Teenwork/Text Message Group will receive both the Teenwork intervention and the text message reminders (as described above). Participants in the Usual Care Group will receive the same intervention as the Teenwork/Text Message Group, but not until after 1 year.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • Behavioral: Teenwork intervention
    Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
  • Behavioral: Text message reminders
    Text message reminders to check blood glucose levels at self-selected times
Study Arms  ICMJE
  • Experimental: Teenwork Group
    Teen/family will receive the Teenwork intervention at each quarterly study visit.
    Intervention: Behavioral: Teenwork intervention
  • Experimental: Teenwork/Text Message Group
    Teen/family will receive the Teenwork intervention at each quarterly study visit. Teen will receive text message reminders to check blood glucose levels at self-selected times.
    Interventions:
    • Behavioral: Teenwork intervention
    • Behavioral: Text message reminders
  • Experimental: Text Message Group
    Teen will receive text message reminders to check blood glucose levels at self-selected times.
    Intervention: Behavioral: Text message reminders
  • No Intervention: Usual Care Group
    Teen/family will receive routine clinical care for the first year of the study (the time period for assessment of primary outcomes). After year 1, teen/family will receive the Teenwork intervention at each remaining study visit and teen will receive text message reminders to check blood glucose levels at self-selected times.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2015)
310
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2013)
300
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Youth age 13-17 years
  • Diagnosis of type 1 diabetes according to American Diabetes Association criteria
  • Diabetes duration ≥6 months
  • Daily insulin dose ≥0.5 units/kg
  • A1c ≥6.5%and ≤11%
  • Willingness to check blood glucose levels
  • Cell phone with text messaging ability
  • Clinic attendance

    1. At least one clinic visit at the clinical site in the previous 12 months
    2. Anticipated care at the clinical site for the duration of the study
  • Fluency in English (reading, writing, and speaking) for child and parent/guardian
  • Enrollment no later than December of the teen's senior year of high school

Exclusion Criteria:

  • Pregnancy in the youth participant
  • Significant developmental or cognitive disorder that would prevent full study participation
  • Significant mental illness, defined by either major psychiatric disorder (e.g., diagnosed eating disorder, major psychoses) or inpatient psychiatric admission within the previous 6 months
  • Failure to understand that the 2-way text messaging does NOT result in immediate response from a health care professional; this will be assessed at the time of informed consent/assent
  • Participation in another intervention study within the 3 months prior to enrollment
  • Other psychosocial, medical, or family issues, as assessed by the teen's pediatric team, that would prevent full study participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01892280
Other Study ID Numbers  ICMJE 2012-11
R01DK095273 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lori Laffel, Joslin Diabetes Center
Study Sponsor  ICMJE Joslin Diabetes Center
Collaborators  ICMJE
  • Baylor College of Medicine
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Lori Laffel, MD, MPH Joslin Diabetes Center
Principal Investigator: Barbara J. Anderson, PhD Texas Children's Hospital/Baylor College of Medicine
PRS Account Joslin Diabetes Center
Verification Date September 2019

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