Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatments hit-aided approach, contracted conflict management system, hit plus contracted conflict management
Sponsor Indiana University
Start date May 2014
End date February 2017
Trial size 90 participants
Trial identifier NCT02115555, IRB-04, IRB00000219

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
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.
hit-aided approach
Subjects randomized to this approach will be using the HIT-aided monitor.
(Experimental)
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.
contracted conflict management system
Subjects randomized to this arm will be using the behavioral contracted conflict management system.
(Experimental)
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.
hit plus contracted conflict management
Subjects randomized to this arm will use both the HIT-aided approach and the behavioral contract conflict management system.

Primary Outcomes

Measure
Glycemic Control using HBA1C
time frame: Baseline, 3 months, and 6 months

Secondary Outcomes

Measure
Frequency of self monitoring blood glucose measurement
time frame: Baseline, 3 months, 6 months
Quality of Life
time frame: Baseline and 6 months
Family dynamics
time frame: Baseline and 6 months
Treatment Adherence Behaviors
time frame: Once per month for 6 months

Eligibility Criteria

Male or female participants from 12 years up to 18 years old.

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

Additional Information

Official title Advancing Diabetes Management in Adolescents Using Health Information Technology
Principal investigator Tamara Hannon, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Indiana University.