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Use of a Telehomecare Program for Young Patients With New Onset Type 1 Diabetes

NCT01401790 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2011-07-25

No results posted yet for this study

Summary

In a Pediatric University Teaching Hospital in Montreal, an Intelligent Distance Patient Monitoring Program was developed to allow for:

* Automatic download of blood glucose levels
* Automatic alerts indicating hypoglycemias, hyperglycemias and ketones to the medical team
* Changes in treatment plan by the diabetes professionals
* E mail exchanges between families and health care professionals
* Reinforcement of teaching program

Use of this program does not replace the existing diabetes education program nor does it preclude contacts with the diabetes team. This service was devised to complement the care already in place for families of children and adolescents with diabetes, hence the term ''telehomecare-enhanced'' approach.

Hypotheses

* This approach would not incur more health problems for Web e Phone users when compared to patients treated by the ''conventional'' approach (telephone and FAX).
* Use of the Web e Phone would save time for members of the diabetes health providers and consequently cut costs.
* This means of communication would be acceptable and user friendly for both families and health care professionals.

OBJECTIVE - To determine the effects of a telehomecare (THC) program used for 3 months in families of children and adolescents with newly diagnosed type 1 diabetes.

RESEARCH DESIGN AND METHODS - A bilingual telehomecare program was developed for type 1 diabetes at the Centre Hospitalier Universitaire Sainte-Justine in Montreal. Between February 2008 and August 2009, newly diagnosed patients and their family were randomly assigned to the standard education program or to the telehomecare-enhanced group. Outcomes of interest were patients' and parents' health (reported number for total and nocturnal hypoglycemias; quality of life using the Diabetes Quality of life for Youth questionnaire and a validated Life Habits survey); knowledge of diabetes (using pre and post intervention questionnaires); organizational impacts (number and time for contacts with the nurses or with the physician on call) and family satisfaction with the software application.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Telehomecare (Intelligent Distance Patient Monitoring)

Randomized patients were to be taugth and to use for 3 months a telehomecare program designed for * Automatic download of blood glucose levels * Automatic alerts indicating hypoglycemias, hyperglycemias and ketones to the medical team * Changes in treatment plan by the diabetes professionals * E mail exchanges between families and health care professionals * Reinforcement of teaching program

OTHER

Standard education and follow up at diabetes clinic

Patients allocated to the control branch receive standard diabetes teaching and care.

Sponsors & Collaborators

  • Huot, Celine, M.D.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01401790 on ClinicalTrials.gov