Use of a Telehomecare Program for Young Patients With New Onset Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

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.
    

Intervention name(s): Telehomecare (Intelligent Distance Patient Monitoring); Standard education and follow up at diabetes clinic
Intervention type(s): Device; Other
Intervention description(s): 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; Patients allocated to the control branch receive standard diabetes teaching and care.
Other intervention name(s): Telehealth; Telemonitoring; Standard diabetes care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Children; Adolescents; Telehomecare