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Open Access Study protocol

A cluster randomised pragmatic trial applying Self-determination theory to type 2 diabetes care in general practice

Lise Juul1*, Helle T Maindal1, Vibeke Zoffmann2, Morten Frydenberg3 and Annelli Sandbaek1

Author Affiliations

1 Department of Public Health, Section for General Practice, Aarhus University, Denmark

2 Steno Diabetes Centre, Gentofte, Denmark

3 Department of Public Health, Section for Biostatistics, Aarhus University, Denmark

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BMC Family Practice 2011, 12:130  doi:10.1186/1471-2296-12-130

Published: 24 November 2011

Abstract

Background

Treatment recommendations for prevention of type 2 diabetes complications often require radical and life-long health behaviour changes. Observational studies based on Self-determination theory (SDT) propose substantial factors for the maintenance of behaviour changes and concomitant well-being, but experimental research is needed to develop and evaluate SDT-based interventions. The aims of this paper were to describe

1) the design of a trial assessing the effectiveness of a training course for practice-nurses in autonomy support on patient-perceived motivation, HbA1, cholesterol, and well-being among a diabetes population,

2) the actual intervention to a level of detail that allows its replication, and

3) the connection between SDT recommendations for health care-provider behaviour and the content of the training course.

Methods/Design

The study is a cluster-randomised pragmatic trial including 40 Danish general practices with nurse-led diabetes consultations, and the associated diabetes population. The diabetes population was identified by registers (n = 4034).

The intervention was a 16-hour course with interactive training for practice nurses. The course was delivered over 4 afternoons at Aarhus University and one 1/2 hour visit to the practice by one of the course-teachers over a period of 10 months (0, 2, 5, 10 mths.). The intervention is depicted by a PaT Plot showing the timeline and the characteristics of the intervention components.

Effectiveness of the intervention will be assessed on the diabetes populations with regard to well-being (PAID, SF-12), HbA1c- and cholesterol-levels, perceived autonomy support (HCCQ), type of motivation (TSRQ), and perceived competence for diabetes care (PCD) 15-21 months after the core course; the completion of the second course afternoon. Data will be retrieved from registers and by questionnaires.

Discussion

Challenges and advantages of the pragmatic design are discussed. In a real-world setting, this study will determine the impact on motivation, HbA1c, cholesterol, and well-being for people with diabetes by offering a training course in autonomy support to practice-nurses from general practices with nurse-led consultations.

Trial registration

ClinicalTrials.gov: NCT01187069