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OpenTrials
Completed

NCT Number: NCT02115555

Advancing Diabetes Management in Adolescents Using Health Information Technology

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riley Children's Specialties, Carmel, Indiana, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIT-aided approach

Behavioral

Subjects randomized to this approach will be using the HIT-aided monitor.

Contracted conflict management system

Behavioral

Subjects randomized to this arm will be using the behavioral contracted conflict management system.

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.

Primary outcomes

  1. Glycemic Control using HBA1C

    Time frame: Baseline, 3 months, and 6 months

    Change in Glycemic Control

Secondary outcomes

  1. Frequency of self monitoring blood glucose measurement

    Time frame: Baseline, 3 months, 6 months

    change in Self-monitoring blood glucose measurement

  2. Quality of Life

    Time frame: 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.

  3. Family dynamics

    Time frame: Baseline and 6 months

    Change in family dynamics measured by the Cornell Parent Behavior Description Scale and the Helping for Health Inventory.

  4. Treatment Adherence Behaviors

    Time frame: 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 outcomes

  1. Satisfaction

    Time frame: 3 month and 6 month

    Patient and parent satisfaction with the intervention with questions determined by the investigator.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 16, 2014
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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