Clinical trial NCT00394875: The Diabetes Specialist Nurse as Delegated Main Care Provider for Patients With Type 2 Diabetes
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Randomized controlled trial
Delegation, Professional
Nurses
Lead sponsor: Medical Research Foundation, The Netherlands
Sponsor class: OTHER
Collaborators: name: Netherlands: Ministry of Health, Welfare and Sports
name: Langerhans Foundation, the Netherlands
First posted: 2006-11-02
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: mean decrease in:
measure: HbA1c
measure: blood pressure
measure: total cholesterol
measure: LDL cholesterol
measure: cholesterol/HDL-ratio
measure: proportion of patients achieving ranges of:
measure: glycaemic control
measure: lipid profile
Secondary outcomes:
measure: health related quality of life (HRQOL)
measure: diabetes related symptoms
measure: patients' satisfaction
measure: health care consumption and costs
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Clinics
Study officials:
affiliation: 2. Department of General Practice, University of Groningen, Groningen, The Netherlands
name: Sebastiaan T Houweling, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of General Practice, University of Groningen, Groningen, The Netherlands
name: Betty Meyboom-de Jong, PhD
role: STUDY_CHAIR
affiliation: 3. Centre of Excellence, Isala Clinics, Zwolle, The Netherlands
name: Henk Bilo, PhD
role: STUDY_CHAIR
References: