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

July 22, 2011 updated by: Huot, Celine, M.D.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

STUDY PROTOCOL

This is a randomized controlled study, unblinded.

The recruitment occured on Day 3 of teaching: random assignment (1:1) to receive either traditional follow up (telephone contacts and FAX communications) with the designated nurse OR a follow up with telehomecare PLUS the follow up by a specialized nurse.

If the patient is designated to telehomecare, the training is provided on day of recruitment and patient leaves with the Web e Phone. Activation of the device must be done at home to enable for transmission of information.

Families complete questionnaires to evaluate knowledge, Quality of Life Questionnaires (Skinner modified), a validated Life Habits survey and a satisfaction questionnaire at recruitment (time 0) and at study completion (3 months) (Children must be aged more than 8 years).

All reported hypoglycemias (less than 3 mmol/L) and nocturnal hypoglycemias by any means (telephone, FAX or Web e Phone) during the follow up period (suggested for 3 months) are to be accounted for.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Centre Hospitalier Universitaire Sainte-Justine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child or adolescent with newly diagnosed type 1 diabetes

Exclusion Criteria:

  • Inability to write or communicate in writing in French or English Blindness Exclusive follow up in another health center once teaching is complete

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telehomecare
3 month use of a new telehomecare program
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 Names:
  • Telehealth
  • Telemonitoring
Active Comparator: Control
3 month regular education program and follow up at the Diabetes Clinic
Other: Standard education and follow up at diabetes clinic
Patients allocated to the control branch receive standard diabetes teaching and care.
Other Names:
  • Standard diabetes care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' health (reported number of hypoglycemias and nocturnal hypoglycemias)
Time Frame: 3 months
All reported hypoglycemias (less than 3 mmol/L) by any means (telephone, FAX or Web e Phone) during the follow up period (3 months) to be accounted for in intervention and control groups
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients and parents' health
Time Frame: 3 months
Families complete questionnaires to evaluate Quality of Life Questionnaires (Skinner modified) and a validated Life Habits Questionnaire at recruitment and at study completion (Children must be more than 8 years).
3 months
Knowledge of diabetes
Time Frame: 3 months
using in house validated pre and post intervention questionnaires
3 months
Organizational impacts
Time Frame: 3 months
Number and time required for contacts with the nurse at the clinic and / or with the physician on call
3 months
Family satisfaction with the software application
Time Frame: 3 months
Using an in house validated questionnaire
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huot, Celine, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

July 22, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Estimate)

July 25, 2011

Last Update Submitted That Met QC Criteria

July 22, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUSTEJUSTINE2644

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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