Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents
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Purpose
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
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes |
Behavioral: nurse-counselling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial |
- Patient's acceptance of the disease evaluated by an analogical visual scale rating [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of diabetic acidosis having required hospitalization, [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 77 |
| Study Start Date: | March 2006 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nurse counseling
Phone calls performed by nurse 15 days after each monthly visit
|
Behavioral: nurse-counselling
Phone calls performed by nurse 15 days after each monthly visit
|
|
No Intervention: Control
Normal monthly follow-up without phone calls
|
Eligibility| Ages Eligible for Study: | 13 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged 13 to 18 years with a type1 diabetes diagnosed at least one year earlier,
- HbA1c rate > 8 %.
Exclusion Criteria:
- HbA1c < 8 %;
- patients participating in another study
Contacts and Locations More Information
No publications provided
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT00308256 History of Changes |
| Other Study ID Numbers: | 2005.395 |
| Study First Received: | March 28, 2006 |
| Last Updated: | December 28, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Hospices Civils de Lyon:
|
Type1 diabetes; nurse-counselling; adolescent |
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