Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents
NCT ID: NCT00308256
Last Updated: 2011-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2006-03-31
2011-08-31
Brief Summary
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Working Hypothesis:
We hypothesized that a stricter control of glycaemia by nurse-counselling could probably improve metabolic control in adolescents with type 1 diabetes.
Objectives:
To show that nurse-counselling may improve levels of patient satisfaction.
Methodology:
The main criterion is the patient acceptance of diabetes measured by an analogical visual scale rated from 0 (I cope very well with my diabetes, I cope very badly with my diabetes) to 10 cm. The scale will be measured every quarter within 12 months follow-up. We wish to improve patient's appreciation by 10 mm, near to "I cope very well with my diabetes".
This is a randomised parallel group study with 36 subjects in each group. During the follow-up, the "routine follow-up" group will continue its routine care. The "complementary follow-up" group will be called by nurses every 15 days and consult monthly. HbA1c is the secondary criterion and will be measured every 3 months.
The total study duration is 18 months including 6 months for the recruitment and 12 months for the patients follow-up
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Nurse counseling
Phone calls performed by nurse 15 days after each monthly visit
nurse-counselling
Phone calls performed by nurse 15 days after each monthly visit
Control
Normal monthly follow-up without phone calls
No interventions assigned to this group
Interventions
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nurse-counselling
Phone calls performed by nurse 15 days after each monthly visit
Eligibility Criteria
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Inclusion Criteria
* HbA1c rate \> 8 %.
Exclusion Criteria
* patients participating in another study
13 Years
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Marc NICOLINO, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Marc Nicolino
Lyon, , France
Countries
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References
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Kassai B, Rabilloud M, Bernoux D, Michal C, Riche B, Ginhoux T, Laudy V, Terral D, Didier-Wright C, Maire V, Dumont C, Cottancin G, Plasse M, Jeannoel GP, Khoury J, Bony C, Lievre M, Drai J, Nicolino M. Management of adolescents with very poorly controlled type 1 diabetes by nurses: a parallel group randomized controlled trial. Trials. 2015 Sep 8;16:399. doi: 10.1186/s13063-015-0923-7.
Other Identifiers
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2005.395
Identifier Type: -
Identifier Source: org_study_id