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Completed

NCT Number: NCT01401790

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

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.

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Key information

Conditions

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

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Telehomecare (Intelligent Distance Patient Monitoring)

Device

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

Standard education and follow up at diabetes clinic

Other

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

Other names: Standard diabetes care

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. Knowledge of diabetes

    Time frame: 3 months

    using in house validated pre and post intervention questionnaires

  3. 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

  4. Family satisfaction with the software application

    Time frame: 3 months

    Using an in house validated questionnaire

Sponsors and collaborators

Lead sponsor

Huot, Celine, M.D.

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 25, 2011
Registry last updated
Jul 25, 2011

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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