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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Joslin Diabetes Center
Sponsor:
Collaborators:
Baylor College of Medicine
Information provided by (Responsible Party):
Lori Laffel, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01892280
First received: July 1, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Behavioral: Teenwork intervention
Behavioral: Text message reminders

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study

Resource links provided by NLM:


Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • Change in glycemic control from baseline to 1 year [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)


Secondary Outcome Measures:
  • Change in glycemic control from 1 year to 18 months [ Time Frame: 1 year and 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 300
Study Start Date: November 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teenwork Group
Teen/family will receive the Teenwork intervention at each quarterly study visit.
Behavioral: Teenwork intervention
Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
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.
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
Experimental: Text Message Group
Teen will receive text message reminders to check blood glucose levels at self-selected times.
Behavioral: Text message reminders
Text message reminders to check blood glucose levels at self-selected times
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.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01892280

Contacts
Contact: Lori Laffel, MD, MPH 617-309-2603

Locations
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Niza Tonarely, MA    617-309-4645    niza.tonarely@joslin.harvard.edu   
Principal Investigator: Lori Laffel, MD, MPH         
United States, Texas
Texas Children's Hospital/Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Yuliana Rojas, BA    832-824-7216    yuliana.rojas@bcm.edu   
Principal Investigator: Barbara Anderson, Ph.D         
Sponsors and Collaborators
Joslin Diabetes Center
Baylor College of Medicine
Investigators
Principal Investigator: Lori Laffel, MD, MPH Joslin Diabetes Center
Principal Investigator: Barbara J. Anderson, PhD Texas Children's Hospital/Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Lori Laffel, Chief, Pediatric, Adolescent, & Young Adult Section; Investigator, Genetics & Epidemiology Section, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01892280     History of Changes
Other Study ID Numbers: 2012-11, R01DK095273
Study First Received: July 1, 2013
Last Updated: July 7, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014