The Diabetes Specialist Nurse as Delegated Main Care Provider for Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Netherlands: Ministry of Health, Welfare and Sports
Langerhans Foundation, the Netherlands
Information provided by:
Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT00394875
First received: October 31, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

To determine whether the management of type 2 diabetes mellitus (DM2) can be transferred from an internist to a supervised nurse specialized in diabetes (NSD) with a comparable quality of clinical care, health care costs, health related quality of life (HRQOL), and patient satisfaction.


Condition Intervention
Diabetes Mellitus, Type 2
Procedure: Treated and educated by nurses specialized in diabetes.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Diabetes Specialist Nurse as Delegated Main Care Provider for Patients With Type 2 Diabetes in a Secondary Care Setting: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
  • mean decrease in:
  • HbA1c
  • blood pressure
  • total cholesterol
  • LDL cholesterol
  • cholesterol/HDL-ratio
  • proportion of patients achieving ranges of:
  • glycaemic control
  • lipid profile

Secondary Outcome Measures:
  • health related quality of life (HRQOL)
  • diabetes related symptoms
  • patients' satisfaction
  • health care consumption and costs

Estimated Enrollment: 81
Study Start Date: March 2002
Estimated Study Completion Date: January 2005
Detailed Description:

Diabetes mellitus type 2 (DM2) is a chronic, progressive illness which causes considerable morbidity and premature mortality.1-2 The worldwide prevalence of DM2 is high and is increasing steadily, also in The Netherlands.3-4 The burden of DM2 on health care has also increased because of the intensified cardiovascular risk management being practiced to prevent macrovascular morbidity and mortality in these patients.5 In the treatment of DM2, tight guidelines are increasingly recommended for optimizing glycaemia, blood pressure and lipid profile.6 Therefore, the burden of treatment has increased and will further increase per patient as well as per population with DM2. In order to meet this problem, we tested, in the current study, the hypothesis that well defined routine aspects in diabetes care, previously handled only by medical doctors in secondary care setting, may be safely transferred to supervised nurses specialized in diabetes (NSD), including the prescription of medication, resulting in at least the same quality of clinical care, health care costs, health related quality of life (HRQOL), and patient satisfaction.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with DM2 who were referred by GPs to the diabetes outpatient clinics

Exclusion Criteria:

  • macroalbuminuria
  • serum creatinine level > 135 mol/l,
  • Cockcroft < 50 ml/min
  • alanine aminotransferase (ALT) > 120 U/l
  • pregnant woman
  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: NCT00394875

Locations
Netherlands
Isala Clinics
Zwolle, Netherlands, 8025 AB
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Netherlands: Ministry of Health, Welfare and Sports
Langerhans Foundation, the Netherlands
Investigators
Principal Investigator: Sebastiaan T Houweling, PhD 2. Department of General Practice, University of Groningen, Groningen, The Netherlands
Study Chair: Betty Meyboom-de Jong, PhD Department of General Practice, University of Groningen, Groningen, The Netherlands
Study Chair: Henk Bilo, PhD 3. Centre of Excellence, Isala Clinics, Zwolle, The Netherlands
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00394875     History of Changes
Other Study ID Numbers: IC-06-03-SL
Study First Received: October 31, 2006
Last Updated: October 31, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Research Foundation, The Netherlands:
Randomized controlled trial
Delegation, Professional
Nurses

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014