Use of a Telehomecare Program for Young Patients With New Onset Type 1 Diabetes
NCT ID: NCT01401790
Last Updated: 2011-07-25
Study Results
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Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2008-02-29
2009-08-31
Brief Summary
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* 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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Telehomecare
3 month use of a new telehomecare program
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
Control
3 month regular education program and follow up at the Diabetes Clinic
Standard education and follow up at diabetes clinic
Patients allocated to the control branch receive standard diabetes teaching and care.
Interventions
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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
Standard education and follow up at diabetes clinic
Patients allocated to the control branch receive standard diabetes teaching and care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Months
18 Years
ALL
No
Sponsors
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Huot, Celine, M.D.
OTHER
Responsible Party
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Centre Hospitalier Universitaire Sainte-Justine
Locations
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Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
Related Links
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Description of technological evaluation ongoing in institution where the project is done
Other Identifiers
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CHUSTEJUSTINE2644
Identifier Type: -
Identifier Source: org_study_id
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