Advancing Diabetes Management in Adolescents Using Health Information Technology

The study will compare three treatment strategies to look at the best clinical outcomes.

The investigator hypothesizes that the combined approach of a health information technology program plus a conflict-management contract will lead to the best outcomes.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: HIT-aided approach; Behavioral: Contracted conflict management system; Behavioral: HIT plus contracted conflict management

Detailed Description

This study will compare three strategies for enhancing adherence to diabetes care in our population. The study will look at which strategy results in the best short-term clinical outcomes for the population. Also, the study will look at patient satisfaction of contact with his/her health care team, quality of life, and family dynamics.

The three arms are:

1. HIT (health information technology) aided approach
2. Contracted conflict-management strategy
3. Combination of the HIT-aided approach and the contracted conflict management strategy

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Riley Children's Specialties
    • Indianapolis, Indiana, United States, 46202
      • Riley Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type 1 diabetes diagnosed for at least 6 months
• At least one or more parent/guardian who agrees to participate

Exclusion Criteria:

• Other chronic diseases with the exception of well-controlled asthma or treated thyroid disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIT-aided approach; Adolescents and their parents randomized to this arm will be oriented on a HIT system. The system transmits self monitoring blood glucose self monitoring blood glucose data to a secure web portal. The subject will receive messages from the HIT system on the meter based upon the Self Monitored Blood glucose tests.	Behavioral: HIT-aided approach; Subjects randomized to this approach will be using the HIT-aided monitor.
Experimental: Contracted conflict management system; Adolescent-parent pairs will meet with a health educator to establish a behavioral contract that will set patient-centered self-management goals for the adolescent.	Behavioral: Contracted conflict management system; Subjects randomized to this arm will be using the behavioral contracted conflict management system.
Experimental: HIT plus contracted conflict management; Adolescents and their parents randomized to this arm will be oriented on a HIT system. The system transmits self monitoring blood glucose data to a secure web portal. The subject will receive messages from the HIT system on the meter based upon the tests. In addition, adolescent-parent pairs will meet with a health educator to establish a behavioral contract that will set patient-centered self-management goals for the adolescent. This arm combines arms 1 and 2.	Behavioral: HIT plus contracted conflict management; Subjects randomized to this arm will use both the HIT-aided approach and the behavioral contract conflict management system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Control using HBA1C	Change in Glycemic Control	Baseline, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of self monitoring blood glucose measurement	change in Self-monitoring blood glucose measurement	Baseline, 3 months, 6 months
Quality of Life	Change in Diabetes-specific quality of life measures will be measured by the Varney's Pediatric Quality of Life 3.0 Diabetes Module.	Baseline and 6 months
Family dynamics	Change in family dynamics measured by the Cornell Parent Behavior Description Scale and the Helping for Health Inventory.	Baseline and 6 months
Treatment Adherence Behaviors	Change in treatment adherence behaviors measured by the Self-Care Inventory with supplemental questions determined by the investigator.	Once per month for 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction	Patient and parent satisfaction with the intervention with questions determined by the investigator.	3 month and 6 month

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Tamara Hannon, MD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 17, 2014
• First Submitted That Met QC Criteria: April 14, 2014
• First Posted (Estimate): April 16, 2014

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: diabetes; adolescents; type 1; heath information technology
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: IRB-04, IRB00000219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared via presentation and publications.