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

NCT01187069 | Completed DMC

• 1 other identifier: 2009-41-3065
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Motivation; patients with type 2 diabetes; practice nurses; general practice; Self-determination Theory

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• HDL-cholesterol

  Last measurement within 12 months before - and 15 months after nurse participation in the course

• LDL-cholesterol

  Last measurement within 12 months before - and 15 months after nurse participation in the course

• Perceived autonomy support (HCCQ)

  15 months from nurse participation in the course

• Type of motivation (TSRQ)

  15 months from nurse participation in the course

• Perceived competence (PCS)

  15 months from nurse participation in the course

Study Arms (2)

Training course for practice nurses in autonomy support

EXPERIMENTAL

Behavioral: Training course for practice nurses in autonomy support

Control

NO INTERVENTION

Control practices were randomly drawn from among intervention practice applicants and were informed by mail about their status as control practice.

Interventions

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.

Training course for practice nurses in autonomy support

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• TrygFonden, Denmark: collaborator
• Sygekassernes Helsefond: collaborator
• Lundbeck Foundation: collaborator

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

Related Publications (2)

• Juul L, Maindal HT, Zoffmann V, Frydenberg M, Sandbaek A. Effectiveness of a training course for general practice nurses in motivation support in type 2 diabetes care: a cluster-randomised trial. PLoS One. 2014 May 5;9(5):e96683. doi: 10.1371/journal.pone.0096683. eCollection 2014.

  PMID: 24798419 DERIVED

• Juul L, Maindal HT, Zoffmann V, Frydenberg M, Sandbaek A. A cluster randomised pragmatic trial applying Self-determination theory to type 2 diabetes care in general practice. BMC Fam Pract. 2011 Nov 24;12:130. doi: 10.1186/1471-2296-12-130.

  PMID: 22111524 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: August 23, 2010
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 20, 2012

Record last verified: 2012-08

Locations

DK (1)