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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Training course for practice nurses in autonomy support

• Registration Number: NCT01187069
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-17
• Last Update Posted: 2012-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training course for practice nurses in autonomy support	Training course for practice nurses in autonomy support	-

Primary Outcome Measures

Name	Time	Method
HbA1c	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 Outcome Measures

Name	Time	Method
HDL-cholesterol	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)
LDL-cholesterol	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)
Perceived autonomy support (HCCQ)	15 months from nurse participation in the course	Modified health care climate quastionaire (Self-determination Theory)
Type of motivation (TSRQ)	15 months from nurse participation in the course	The treatment self-regulation quastionaire (Self-determination Theory)
Perceived competence (PCS)	15 months from nurse participation in the course	perceived competence scale (Self-determination Theory)
Total-cholesterol	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)
Self-rated health (SF-12)	15 months from nurse participation in the course
Problem Areas In Diabetes scale (PAID)	15 months from nurse participation in the course

Trial Locations

Locations (1)

Department of General Practice, School of Public Health, Aarhus University; 🇩🇰 Aarhus, Denmark