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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Telehomecare (Intelligent Distance Patient Monitoring)
* Other: Standard education and follow up at diabetes clinic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehomecare<br>3 month use of a new telehomecare program | Device: Telehomecare (Intelligent Distance Patient Monitoring)<br>* 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<br>* Other names: Telemonitoring;|
| Active Comparator: Control<br>3 month regular education program and follow up at the Diabetes Clinic | Other: Standard education and follow up at diabetes clinic<br>* Patients allocated to the control branch receive standard diabetes teaching and care.<br>* Other names: Standard diabetes care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' health (reported number of hypoglycemias and nocturnal hypoglycemias) | 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 | 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 | using in house validated pre and post intervention questionnaires | 3 months | 
| Organizational impacts | 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 | Using an in house validated questionnaire | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Adolescents, Telehomecare