Research settings
This study was conducted at a diabetes clinic, located within a university hospital in Denmark with an intake of patients from both urban and rural areas in the region. The hospital is a local hospital with an intake area that reflects other hospital intake areas in Denmark. Patients can be referred by their general practitioner or other hospital departments to the diabetes clinic. At the clinic, patients are offered ongoing individual counselling by dietitians, nurses or physicians and group education delivered by a multidisciplinary healthcare team over 4 days. The 4 day diabetes education programme includes approximately eight to ten patients and focuses on a range of themes such as diabetes treatment, prevention of diabetes-related complications, self-monitoring of blood glucose, diet, physical activity, alcohol use and issues regarding insurance. The teaching method is based on guided self-determination designed to guide patients and professionals in mutual problem-solving [24].
Research participants and design
Patients were eligible if they had type 1 or type 2 diabetes mellitus, were over 18 years of age and had participated in the group education programme offered at the diabetes clinic. Exclusion criteria included pregnancy, severe debilitating disease and cognitive deficit. The patients were informed at day 1 and recruited at day 4 while participating in the group education programme. Following informed consent, the patients were randomised to either a control group or an intervention group. Randomisation was done immediately after participation in the group education programme. No stratification was used. All outcome measures were assessed at randomisation, 1 and 2 years after randomisation in both groups. Randomisation was generated by random permuted blocks, with allocation concealment by sequentially numbered, sealed, opaque envelopes. The person generating the allocation scheme did not administer the allocation of the patients to the two groups and was not part of the research team.
The sample size was determined by a power calculation. With 352 patients, 176 in each group, the trial can detect a 0.4% difference in HbA1c. The power was set to 90%. This calculation was based on a standard deviation of 1.15 in the HbA1c value and a 5% two-sided significance level.
Usual care
Medical treatment was not part of the intervention. All participants, irrespective of participation in the intervention group or the control group, therefore underwent the same routine check-up at their general practitioner or outpatient clinic in charge of their diabetes care. This usually involved four physician visits per year. Biochemical tests and examinations were usually performed during the visits in accordance with national diabetes guidelines. Individual counselling and recommendations based on the results of the examinations, biochemical tests and their self-monitoring of blood glucose was given. Renewal of prescribed medication and test strips for blood glucose monitoring were also given at these check-ups. Patients could be referred for individual counselling in change of diet, physical activity, smoking habits and alcohol abuse if required by their usual healthcare provider.
Research intervention
The theoretical approach of the intervention was based on self-efficacy theory and MI spirit. Perceived self-efficacy is defined as people’s beliefs about their capabilities of producing designated levels of performance exercising influence over events that affect their lives [25]. MI was used as a method to facilitate this process. MI is a directive counselling style for eliciting behaviour change by helping patients to explore and resolve ambivalence [26, 27].
In addition to usual care, patients in the intervention group received a 1 year MI programme consisting of five individual counselling sessions lasting approximately 45 min and offered at 1, 3, 6, 9 and 12 months. Each participant in the intervention group had a healthcare professional assigned to them who was trained in MI. The style of the interview was: (1) seeking to understand the person’s frame of reference; (2) expressing acceptance and affirmation; (3) eliciting and selectively reinforcing the client’s own self-motivational statements of problem recognition, concern, desire and intention to change, and ability to change; (4) exploring the client’s degree of readiness to change; and (5) affirming the client’s freedom of choice and self-direction. The role of exploring readiness to change was that this was used as a component of the therapeutic process and not an outcome. Each session followed a semi-structured interview format of MI, especially developed for this intervention programme. Participants brought up any problematic issues related to diabetes self-care during sessions. The participants in the intervention group could be referred by the healthcare professional to individual counselling in changes of diet, a smoking cessation programme, counselling in alcohol abuse and an exercise programme, as they required.
Education of the healthcare professionals prior to the intervention
Three diabetes specialist nurses, two dietitians, one physiotherapist and one psychologist were educated to carry out MI. They were all coached by a MI trainer from the Motivational Interviewing Network of Trainers in the Nordic countries. The course comprised a 5 day theoretical introduction to strategies in MI. The course was followed by three practical coaching sessions every 3 months for 18 months. The theoretical and practical part of the education included training in the key elements of MI, which is generally facilitating through eliciting change talk and exploring ambivalence about behavioural change, while trying to examine discrepancies between the individual’s current behaviour and core values or personal goals. The healthcare professionals were introduced to the MI method including reflective listening and acknowledgement to allow them to be able to clarify the patient’s goals and concerns and elicit reasons for change in the patient’s own words. The role of the healthcare professionals was to coach and support the patient in discovering and developing his/her own resources for change and management at the patient’s request.
After the 5-day course, the healthcare professionals were individually supervised by the MI trainer in ten real patient situations for 1 year. The supervision included videotaping and evaluation inspired by the Motivational Interviewing Treatment Integrity (MITI) coding system (T. B. Moyers, T. Martin, J. K. Manuel, W. R. Miller, D. Ernst, 2007; available to trainers and members of the Motivational Interviewing Network of Trainers [MINT]). The MITI coding system is divided into a global rating and behavioural counts. The global rating is a five-point Likert scale, where 1 indicates low competence in MI and 5 indicates high competence in MI. The behaviour counts reveal MI behaviour in proportion to all behaviour, where a high percentage indicates a high competence in MI.
Measurements
Questionnaires
Competence of diabetes self-management was assessed by validated questionnaires translated into a Danish version in accordance with recommendations [24]. The Problem Areas in Diabetes Scale (PAID) was used to measure diabetes-related distress reported by the participants. This 20-item questionnaire assesses a wide range of feelings related to living with diabetes and diabetes treatment [28, 29]. Each item can be rated on a five point Likert scale ranging from 0 (not a problem) to 4 (‘a serious problem’). When transforming PAID scores into a 0–100 scale, all item scores are summed and multiplied by 1.25, which results in an overall PAID score with higher scores indicating greater emotional distress [30, 31]. High PAID scores are associated with low self-reported adherence [29]. The Perceived Competence for Diabetes Scale (PCDS) was used to measure competence at carrying out the diabetes treatment regime. This is a five item questionnaire assessing the degree to which participants feel confident about dealing with diabetes [32, 33]. Each item can be rated on a seven point Likert scale ranging from 1 (‘not true at all’) to 7 (‘very true’). The score on the PCDS is calculated by averaging the responses on the five items. The minimum average score is the one equalling the lowest possible perceived competence in dealing with diabetes and the maximum average score is 7, equalling the highest possible perceived competence in dealing with diabetes.
Laboratory measurements
One laboratory analysed all the blood samples. Glycaemic control was assessed using HbA1c, which was measured by a high-performance liquid chromatography-based ion exchanged procedure (Tosho Alc 2.2, Tokyo, Japan). The reference range was 4.3–6.3%. Total cholesterol, HDL cholesterol and triacylglycerol levels were measured in serum by enzymatic methods (Boehringer Mannheim Diagnostica, Mannheim, Germany). LDL-cholesterol was calculated by Friedewald’s equation [34].
Clinical measurements
Both height and weight were measured without shoes. Weight was measured without accessories, i.e. wallet, keys, mobile phone. Waist circumference was measured with a measuring tape directly on the individual’s skin. Restrictive garments and clothing were removed. The tape was placed at the uppermost border of the iliac crest horizontal to the floor. Measurement was made at the end of a normal expiration. Blood pressure was measured by the auscultatory method with use of a stethoscope and a sphygmomanometer. An inflatable cuff was placed around the upper left arm, at the same vertical height as the heart. Measurement was made at rest in a sitting position.
Statistical analysis
For data analyses, SPSS (version 18, Chicago, IL, USA) for Windows and STATA (version 11, College Station, TX, USA) were used.
The baseline values are reported as means±SD or n (%). On the basis of an intention to treat analysis, a mixed effects regression model with random intercept was used to compare primary and secondary outcomes at 12 and 24 months between the intervention and control groups, where treatment was taken as the explanatory variable and the baseline value as a covariate. Further, each outcome was adjusted for the covariates, age, sex, type of diabetes, level of education, HbA1c level at baseline, and healthcare professionals delivering the intervention. A random intercept was included in order to account for possible within-individual dependence due to repeated measurements. In the same fashion, a random intercept was included to account for cluster effects due to the healthcare professionals. Results are presented as means (95% CI). A p value of <0.05 was regarded as statistically significant.
Research ethics
The study design was approved by the Regional Scientific Ethics Committee of Southern Denmark (project-ID: VF-20050131) and the study was reported to the Danish Data Protection Agency. All patients were informed about the aim of the study and were included in the study after informed consent. The study was performed in accordance with the Declaration of Helsinki.