Skip to main content
OpenTrials
Completed

NCT Number: NCT01187069

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of General Practice, School of Public Health, Aarhus University

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The intervention-study comprises 40 general practices were:
  • 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 ;
  • 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.

Treatment and study plan

Training course for practice nurses in autonomy support

Behavioral

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. Perceived autonomy support (HCCQ)

    Time frame: 15 months from nurse participation in the course

    Modified health care climate quastionaire (Self-determination Theory)

  4. Type of motivation (TSRQ)

    Time frame: 15 months from nurse participation in the course

    The treatment self-regulation quastionaire (Self-determination Theory)

  5. Perceived competence (PCS)

    Time frame: 15 months from nurse participation in the course

    perceived competence scale (Self-determination Theory)

  6. 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)

  7. Self-rated health (SF-12)

    Time frame: 15 months from nurse participation in the course

  8. Problem Areas In Diabetes scale (PAID)

    Time frame: 15 months from nurse participation in the course

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Lundbeck Foundation
  • Sygekassernes Helsefond
  • TrygFonden, Denmark

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2010
Registry last updated
Aug 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.