Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01187069
Enrollment
40
Registered
2010-08-23
Start date
2009-08-31
Completion date
2011-09-30
Last updated
2012-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

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

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.

Interventions

BEHAVIORALTraining 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.

Sponsors

TrygFonden, Denmark
CollaboratorINDUSTRY
Sygekassernes Helsefond
CollaboratorOTHER
Lundbeck Foundation
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
HbA1cLast measurement within 12 months before - and 15 months after nurse participation in the courseCollected from registers (historical data - not measured as a part of this study)

Secondary

MeasureTime frameDescription
LDL-cholesterolLast measurement within 12 months before - and 15 months after nurse participation in the courseCollected from registers (historical data - not measured as a part of this study)
Perceived autonomy support (HCCQ)15 months from nurse participation in the courseModified health care climate quastionaire (Self-determination Theory)
Type of motivation (TSRQ)15 months from nurse participation in the courseThe treatment self-regulation quastionaire (Self-determination Theory)
HDL-cholesterolLast measurement within 12 months before - and 15 months after nurse participation in the courseCollected from registers (historical data - not measured as a part of this study)
Total-cholesterolLast measurement within 12 months before - and 15 months after nurse participation in the courseCollected 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
Perceived competence (PCS)15 months from nurse participation in the courseperceived competence scale (Self-determination Theory)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026