Advancing Diabetes Management in Adolescents Using Health Information Technology

Indiana University

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Behavioral: HIT plus contracted conflict management; Behavioral: HIT-aided approach; Behavioral: Contracted conflict management system

Study type: Interventional

Funder types: Other

Identifiers

NCT02115555

IRB-04, IRB00000219

Details and patient eligibility

About

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.

Full 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

Enrollment: 129 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 3 patient groups

HIT-aided approach

Experimental group

Description:

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.

Treatment:

Behavioral: HIT-aided approach

Contracted conflict management system

Experimental group

Description:

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.

Treatment:

Behavioral: Contracted conflict management system

HIT plus contracted conflict management

Experimental group

Description:

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.

Treatment:

Behavioral: HIT plus contracted conflict management