Advancing Diabetes Management in Adolescents Using Health Information Technology

Study Overview
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Brief Summary
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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
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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: HIT (health information technology) aided approach Contracted conflict-management strategy Combination of the HIT-aided approach and the contracted conflict management strategy

Official Title
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Advancing Diabetes Management in Adolescents Using Health Information Technology

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: HIT-aided approach
* Behavioral: Contracted conflict management system
* Behavioral: HIT plus contracted conflict management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIT-aided approach<br>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<br>* Subjects randomized to this approach will be using the HIT-aided monitor.<br>|
| Experimental: Contracted conflict management system<br>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<br>* Subjects randomized to this arm will be using the behavioral contracted conflict management system.<br>|
| Experimental: HIT plus contracted conflict management<br>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<br>* Subjects randomized to this arm will use both the HIT-aided approach and the behavioral contract conflict management system.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1, diabetes, adolescents, heath information technology