A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Behavioral: Training course for practice nurses in autonomy support |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care. A Pragmatic Cluster Randomised Controlled Trial in Primary Health Care |
- HbA1c [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ] [ Designated as safety issue: No ]Collected from registers (historical data - not measured as a part of this study)
- HDL-cholesterol [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ] [ Designated as safety issue: No ]Collected from registers (historical data - not measured as a part of this study)
- LDL-cholesterol [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ] [ Designated as safety issue: No ]Collected from registers (historical data - not measured as a part of this study)
- Perceived autonomy support (HCCQ) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]Modified health care climate quastionaire (Self-determination Theory)
- Type of motivation (TSRQ) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]The treatment self-regulation quastionaire (Self-determination Theory)
- Perceived competence (PCS) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]perceived competence scale (Self-determination Theory)
- Total-cholesterol [ Time Frame: Last measurement within 12 months before - and 15 months after nurse participation in the course ] [ Designated as safety issue: No ]Collected from registers (historical data - not measured as a part of this study)
- Self-rated health (SF-12) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]
- Problem Areas In Diabetes scale (PAID) [ Time Frame: 15 months from nurse participation in the course ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | August 2009 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Training course for practice nurses in autonomy support |
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.
|
|
No Intervention: Control
Control practices were randomly drawn from among intervention practice applicants and were informed by mail about their status as control practice.
|
Eligibility| Ages Eligible for Study: | 40 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Denmark | |
| Department of General Practice, School of Public Health, Aarhus University | |
| Aarhus, Denmark, 8000 | |
More Information
No publications provided by University of Aarhus
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01187069 History of Changes |
| Other Study ID Numbers: | 2009-41-3065 |
| Study First Received: | June 14, 2010 |
| Last Updated: | August 17, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by University of Aarhus:
|
Motivation patients with type 2 diabetes practice nurses general practice Self-determination Theory |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013