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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telehomecare (Intelligent Distance Patient Monitoring)
Standard education and follow up at diabetes clinic
Sponsored by
Huot, Celine, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Children, Adolescents, Telehomecare

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire Sainte-Justine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telehomecare

Control

Arm Description

3 month use of a new telehomecare program

3 month regular education program and follow up at the Diabetes Clinic

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
Knowledge of diabetes
using in house validated pre and post intervention questionnaires
Organizational impacts
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
Using an in house validated questionnaire

Full Information

First Posted
July 8, 2011
Last Updated
July 22, 2011
Sponsor
Huot, Celine, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01401790
Brief Title
Use of a Telehomecare Program for Young Patients With New Onset Type 1 Diabetes
Official Title
Use of a Telehomecare Program for Young Patients With New Onset Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Huot, Celine, M.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Children, Adolescents, Telehomecare

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telehomecare
Arm Type
Experimental
Arm Description
3 month use of a new telehomecare program
Arm Title
Control
Arm Type
Active Comparator
Arm Description
3 month regular education program and follow up at the Diabetes Clinic
Intervention Type
Device
Intervention Name(s)
Telehomecare (Intelligent Distance Patient Monitoring)
Other Intervention Name(s)
Telehealth, Telemonitoring
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard education and follow up at diabetes clinic
Other Intervention Name(s)
Standard diabetes care
Intervention Description
Patients allocated to the control branch receive standard diabetes teaching and care.
Primary Outcome Measure Information:
Title
Patients' health (reported number of hypoglycemias and nocturnal hypoglycemias)
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patients and parents' health
Description
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).
Time Frame
3 months
Title
Knowledge of diabetes
Description
using in house validated pre and post intervention questionnaires
Time Frame
3 months
Title
Organizational impacts
Description
Number and time required for contacts with the nurse at the clinic and / or with the physician on call
Time Frame
3 months
Title
Family satisfaction with the software application
Description
Using an in house validated questionnaire
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre Hospitalier Universitaire Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12716807
Citation
Chase HP, Pearson JA, Wightman C, Roberts MD, Oderberg AD, Garg SK. Modem transmission of glucose values reduces the costs and need for clinic visits. Diabetes Care. 2003 May;26(5):1475-9. doi: 10.2337/diacare.26.5.1475.
Results Reference
background
PubMed Identifier
12817805
Citation
d'Annunzio G, Bellazzi R, Larizza C, Montani S, Pennati C, Castelnovi C, Stefanelli M, Rondini G, Lorini R. Telemedicine in the management of young patients with type 1 diabetes mellitus: a follow-up study. Acta Biomed. 2003;74 Suppl 1:49-55.
Results Reference
background
PubMed Identifier
19464030
Citation
Izquierdo R, Morin PC, Bratt K, Moreau Z, Meyer S, Ploutz-Snyder R, Wade M, Weinstock RS. School-centered telemedicine for children with type 1 diabetes mellitus. J Pediatr. 2009 Sep;155(3):374-9. doi: 10.1016/j.jpeds.2009.03.014. Epub 2009 May 21.
Results Reference
background
PubMed Identifier
17329725
Citation
Pare G, Jaana M, Sicotte C. Systematic review of home telemonitoring for chronic diseases: the evidence base. J Am Med Inform Assoc. 2007 May-Jun;14(3):269-77. doi: 10.1197/jamia.M2270. Epub 2007 Feb 28.
Results Reference
background
PubMed Identifier
16670859
Citation
Rami B, Popow C, Horn W, Waldhoer T, Schober E. Telemedical support to improve glycemic control in adolescents with type 1 diabetes mellitus. Eur J Pediatr. 2006 Oct;165(10):701-5. doi: 10.1007/s00431-006-0156-6. Epub 2006 May 3.
Results Reference
background
PubMed Identifier
16525844
Citation
Skinner TC, Hoey H, McGee HM, Skovlund SE; Hvidore Study Group on Childhood Diabetes. A short form of the Diabetes Quality of Life for Youth questionnaire: exploratory and confirmatory analysis in a sample of 2,077 young people with type 1 diabetes mellitus. Diabetologia. 2006 Apr;49(4):621-8. doi: 10.1007/s00125-005-0124-0. Epub 2006 Jan 26.
Results Reference
background
Links:
URL
http://www.chu-sainte-justine.org/Pro/Page.aspx?ID_PAGE=10002900
Description
Description of technological evaluation ongoing in institution where the project is done

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

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