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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Training course for practice nurses in autonomy support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training course for practice nurses in autonomy support<br> | Behavioral: Training course for practice nurses in autonomy support<br>* 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.<br>|
| No Intervention: Control<br>Control practices were randomly drawn from among intervention practice applicants and were informed by mail about their status as control practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Perceived autonomy support (HCCQ) | Modified health care climate quastionaire (Self-determination Theory) | 15 months from nurse participation in the course | 
| Type of motivation (TSRQ) | The treatment self-regulation quastionaire (Self-determination Theory) | 15 months from nurse participation in the course | 
| Perceived competence (PCS) | perceived competence scale (Self-determination Theory) | 15 months from nurse participation in the course | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motivation, patients with type 2 diabetes, practice nurses, general practice, Self-determination Theory