A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care

August 17, 2012 updated by: University of Aarhus

A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care. A Pragmatic Cluster Randomised Controlled Trial in Primary Health Care

A huge challenge in type 2-diabetes care is how to motivate patients towards health behaviour changes. In Denmark, the tendency is that nurses in general practice provide a large part of type 2 diabetes care.

Observational studies support Self-determination Theory by finding autonomous motivation and perceived competence associated with improved HbA1c-levels in patients with type 2 diabetes. Hence, research is needed to develop and test interventions that are autonomy supportive.

Aim To develop a training course for practice-nurses in autonomy support in patients with type 2 diabetes, and to evaluate the effect on patient outcomes.

Methods The development of the intervention was based on literature research and expert meetings. The intervention is evaluated in a cluster randomised controlled trial with 40 Danish general practices,

  • where nurses, before enrolment in the study, provided consultations to patients with type 2 diabetes,
  • and about 2500 patients with type 2 diabetes, identified in a Diabetes Database.

The patients will be followed 15 months from nurse-participation in the course. Data will be obtained from registers and patient-questionnaires. The hypothesis is that patients with type 2 diabetes regardless of education level, age, and gender will benefit from the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of General Practice, School of Public Health, Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The intervention-study comprises 40 general practices were:

    1. more than 50% of the patients with type 2 diabetes, who had participated in diabetes-consultations during the last year from the invitation-date to the project, were seen by a nurse at least once, stated by the practice. The diabetes-consultation should not only include examinations (blood tests and blood pressure measurement), but should also include communication about living with type 2 diabetes ;
    2. enrollment in the project before registration deadline (three weeks after invitation).

Patients with diabetes, alive and affiliated the practices by May 2011, were identified in a a validated diabetes database based on health registers; The national Patient Registry, The national Health Insurance Service registry, the prescription database and the laboratory database in the county.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Training course for practice nurses in autonomy support
Behavioral: Training course for practice nurses in autonomy support
An interactive course consisting of 4X4 hours education in autonomy support over a 6 months period. The main-components in the course are 1) communication skills, 2) introduction to patient work-sheets and 3) a quick up-to-date knowledge about treatment recommendations of type 2 diabetes. Furthermore, the nurses in the intervention-practices receive a half an hour support-visit 4-5 months after the end of the course.
NO_INTERVENTION: Control
Control practices were randomly drawn from among intervention practice applicants and were informed by mail about their status as control practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course
Collected from registers (historical data - not measured as a part of this study)
Last measurement within 12 months before - and 15 months after nurse participation in the course

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HDL-cholesterol
Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course
Collected from registers (historical data - not measured as a part of this study)
Last measurement within 12 months before - and 15 months after nurse participation in the course
LDL-cholesterol
Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course
Collected from registers (historical data - not measured as a part of this study)
Last measurement within 12 months before - and 15 months after nurse participation in the course
Perceived autonomy support (HCCQ)
Time Frame: 15 months from nurse participation in the course
Modified health care climate quastionaire (Self-determination Theory)
15 months from nurse participation in the course
Type of motivation (TSRQ)
Time Frame: 15 months from nurse participation in the course
The treatment self-regulation quastionaire (Self-determination Theory)
15 months from nurse participation in the course
Perceived competence (PCS)
Time Frame: 15 months from nurse participation in the course
perceived competence scale (Self-determination Theory)
15 months from nurse participation in the course
Total-cholesterol
Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course
Collected from registers (historical data - not measured as a part of this study)
Last measurement within 12 months before - and 15 months after nurse participation in the course
Self-rated health (SF-12)
Time Frame: 15 months from nurse participation in the course
15 months from nurse participation in the course
Problem Areas In Diabetes scale (PAID)
Time Frame: 15 months from nurse participation in the course
15 months from nurse participation in the course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Lundbeck Foundation
TrygFonden, Denmark
Sygekassernes Helsefond

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (ESTIMATE)

August 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2012

Last Update Submitted That Met QC Criteria

August 17, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-41-3065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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