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Trial record 7 of 89 for:    new onset type 1 diabetes
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Use of a Telehomecare Program for Young Patients With New Onset Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Huot, Celine, M.D.
ClinicalTrials.gov Identifier:
NCT01401790
First received: July 8, 2011
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 1
 Device: Telehomecare (Intelligent Distance Patient Monitoring)
Other: Standard education and follow up at diabetes clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Use of a Telehomecare Program for Young Patients With New Onset Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Huot, Celine, M.D.:

Primary Outcome Measures:
  • Patients' health (reported number of hypoglycemias and nocturnal hypoglycemias) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Patients and parents' health [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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).

  • Knowledge of diabetes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    using in house validated pre and post intervention questionnaires

  • Organizational impacts [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number and time required for contacts with the nurse at the clinic and / or with the physician on call

  • Family satisfaction with the software application [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Using an in house validated questionnaire


Enrollment: 86
Study Start Date: February 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Standard diabetes care

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401790

Locations
Canada, Quebec
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Huot, Celine, M.D.
  More Information

Additional Information:
Description of technological evaluation ongoing in institution where the project is done  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Celine Huot MD, Centre Hospitalier Universitaire Sainte-Justine
ClinicalTrials.gov Identifier: NCT01401790     History of Changes
Other Study ID Numbers: CHUSTEJUSTINE2644
Study First Received: July 8, 2011
Last Updated: July 22, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Huot, Celine, M.D.:
Children
Adolescents
Telehomecare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013