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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187069
• Other study ID #: 2009-41-3065
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: August 17, 2012
• Start date: August 2009
• Est. completion date: September 2011

Study information

• Verified date: August 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of General Practice, School of Public Health, Aarhus University	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Lundbeck Foundation, Sygekassernes Helsefond, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	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	No
Secondary	HDL-cholesterol	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	No
Secondary	LDL-cholesterol	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	No
Secondary	Perceived autonomy support (HCCQ)	Modified health care climate quastionaire (Self-determination Theory)	15 months from nurse participation in the course	No
Secondary	Type of motivation (TSRQ)	The treatment self-regulation quastionaire (Self-determination Theory)	15 months from nurse participation in the course	No
Secondary	Perceived competence (PCS)	perceived competence scale (Self-determination Theory)	15 months from nurse participation in the course	No
Secondary	Total-cholesterol	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	No
Secondary	Self-rated health (SF-12)		15 months from nurse participation in the course	No
Secondary	Problem Areas In Diabetes scale (PAID)		15 months from nurse participation in the course	No