Type 1 Diabetes
Conditions
Keywords
type 1, diabetes, adolescents, heath information technology
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
Interventions
BEHAVIORALHIT-aided approach
Subjects randomized to this approach will be using the HIT-aided monitor.
BEHAVIORALContracted conflict management system
Subjects randomized to this arm will be using the behavioral contracted conflict management system.
BEHAVIORALHIT plus contracted conflict management
Subjects randomized to this arm will use both the HIT-aided approach and the behavioral contract conflict management system.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control using HBA1C | Baseline, 3 months, and 6 months | Change in Glycemic Control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction | 3 month and 6 month | Patient and parent satisfaction with the intervention with questions determined by the investigator. |
Countries
United States
Outcome results
None listed