ClinicalTrials.gov
ClinicalTrials.gov Menu

Advancing Diabetes Management in Adolescents Using Health Information Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02115555
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Tamara S. Hannon, Indiana University

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: HIT-aided approach Behavioral: Contracted conflict management system Behavioral: HIT plus contracted conflict management Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Advancing Diabetes Management in Adolescents Using Health Information Technology
Actual Study Start Date : May 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIT-aided approach
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
Subjects randomized to this approach will be using the HIT-aided monitor.

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

Experimental: HIT plus contracted conflict management
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
Subjects randomized to this arm will use both the HIT-aided approach and the behavioral contract conflict management system.




Primary Outcome Measures :
  1. Glycemic Control using HBA1C [ Time Frame: Baseline, 3 months, and 6 months ]
    Change in Glycemic Control


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Satisfaction [ Time Frame: 3 month and 6 month ]
    Patient and parent satisfaction with the intervention with questions determined by the investigator.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115555


Locations
United States, Indiana
Riley Children's Specialties
Carmel, Indiana, United States, 46032
Riley Children's Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Tamara Hannon, MD Indiana University School of Medicine

Responsible Party: Tamara S. Hannon, Associate Professor of Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT02115555     History of Changes
Other Study ID Numbers: IRB-04, IRB00000219
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared via presentation and publications.

Keywords provided by Tamara S. Hannon, Indiana University:
type 1
diabetes
adolescents
heath information technology

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases