Advancing Diabetes Management in Adolescents Using Health Information Technology

Type 1 Diabetes Clinical Trial

Official title:

Advancing Diabetes Management in Adolescents Using Health Information Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115555
• Other study ID #: IRB-04, IRB00000219
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: June 2016

Study information

• Verified date: February 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• HIT-aided approach
Subjects randomized to this approach will be using the HIT-aided monitor.
• Contracted conflict management system
Subjects randomized to this arm will be using the behavioral contracted conflict management system.
• HIT plus contracted conflict management
Subjects randomized to this arm will use both the HIT-aided approach and the behavioral contract conflict management system.

Locations

Country	Name	City	State
United States	Riley Children's Specialties	Carmel	Indiana
United States	Riley Children's Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction	Patient and parent satisfaction with the intervention with questions determined by the investigator.	3 month and 6 month
Primary	Glycemic Control using HBA1C	Change in Glycemic Control	Baseline, 3 months, and 6 months
Secondary	Frequency of self monitoring blood glucose measurement	change in Self-monitoring blood glucose measurement	Baseline, 3 months, 6 months
Secondary	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
Secondary	Family dynamics	Change in family dynamics measured by the Cornell Parent Behavior Description Scale and the Helping for Health Inventory.	Baseline and 6 months
Secondary	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