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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 28, 2006 | ||||
| Last Updated Date | October 4, 2007 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Patient's acceptance of the disease evaluated by an analogical visual scale rating | ||||
| Original Primary Outcome Measures ICMJE |
Patient’s acceptance of the disease evaluated by an analogical visual scale rating | ||||
| Change History | Complete list of historical versions of study NCT00308256 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Nurse-Counselling in the Improvement of the type1 Diabetes Control in Adolescents | ||||
| Official Title ICMJE | Effects of Nurse-Counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial | ||||
| Brief Summary | The incidence of type 1 diabetes is increasing in France. A recent cross sectional study has shown that in France, only 15% of children and 26% of adults had HbA1c<7%. Adolescents seem to need particularly a better metabolic control. 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 |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Randomized, Open Label, Uncontrolled, Parallel Assignment | ||||
| Condition ICMJE | Type 1 Diabetes | ||||
| Intervention ICMJE | Behavioral: nurse-counselling | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 72 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 13 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00308256 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 2005.395 | ||||
| Study Sponsor ICMJE | Hospices Civils de Lyon | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hospices Civils de Lyon | ||||
| Verification Date | October 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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