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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIT-aided approach | 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. |
|
| Contracted conflict management system | 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. |
|
| HIT plus contracted conflict management | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIT-aided approach | Behavioral | Subjects randomized to this approach will be using the HIT-aided monitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control using HBA1C | Change in Glycemic Control | Baseline, 3 months, and 6 months |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction | Patient and parent satisfaction with the intervention with questions determined by the investigator. | 3 month and 6 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara Hannon, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Children's Specialties | Carmel | Indiana | 46032 | United States | ||
| Riley Children's Hospital |
Data will be shared via presentation and publications.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Contracted conflict management system | Behavioral | Subjects randomized to this arm will be using the behavioral contracted conflict management system. |
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| HIT plus contracted conflict management | Behavioral | Subjects randomized to this arm will use both the HIT-aided approach and the behavioral contract conflict management system. |
|
| 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 |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |