Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00308256
First received: March 28, 2006
Last updated: December 28, 2011
Last verified: December 2011
  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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Patient's acceptance of the disease evaluated by an analogical visual scale rating [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308256

Locations
France
Marc Nicolino
Lyon, France, 69005
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Marc NICOLINO, MD Hospices Civils de Lyon
  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, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014