Advancing Diabetes Management in Adolescents Using Health Information Technology

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Contracted conflict management system; Behavioral: HIT-aided approach; Behavioral: HIT plus contracted conflict management

• Registration Number: NCT02115555
• Lead Sponsor: Indiana University

Brief 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.

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 Timeline

• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-16
• Study Start: 2014-05
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contracted conflict management system	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.
HIT-aided approach	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.
HIT plus contracted conflict management	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.

Primary Outcome Measures

Name	Time	Method
Glycemic Control using HBA1C	Baseline, 3 months, and 6 months	Change in Glycemic Control

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Riley Children's Hospital; 🇺🇸 Indianapolis, Indiana, United States

Riley Children's Specialties; 🇺🇸 Carmel, Indiana, United States