跳至主要内容
临床试验/NCT02115555
NCT02115555已完成不适用

Advancing Diabetes Management in Adolescents Using Health Information Technology

Indiana University4 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2014年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
4
主要终点
Glycemic Control using HBA1C

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Type 1 diabetes diagnosed for at least 6 months
  • At least one or more parent/guardian who agrees to participate

排除标准

  • Other chronic diseases with the exception of well-controlled asthma or treated thyroid disease

研究组 & 干预措施

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.

干预措施: HIT-aided approach (Behavioral)

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.

干预措施: Contracted conflict management system (Behavioral)

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.

干预措施: HIT plus contracted conflict management (Behavioral)

结局指标

主要结局

Glycemic Control using HBA1C

时间窗: Baseline, 3 months, and 6 months

Change in Glycemic Control

次要结局

  • Frequency of self monitoring blood glucose measurement(Baseline, 3 months, 6 months)
  • Quality of Life(Baseline and 6 months)
  • Family dynamics(Baseline and 6 months)
  • Treatment Adherence Behaviors(Once per month for 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamara S. Hannon

Associate Professor of Pediatrics

Indiana University

研究点 (4)

Loading locations...

相似试验

Advancing Diabetes Management in Adolescents Using... | 临床试验