Original Article. (This manuscript was submitted on 9 February Following blind peer review, it was accepted for publication on 6 June 2012)

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1 483331PED0Supp / D. Trouilloud and J. Regnier 013 Therapeutic education among adults with type diabetes: effects of a three-day intervention on perceived competence, self-management behaviours and glycaemic control David Trouilloud 1 and Jennifer Regnier Abstract: The purpose of this study was to evaluate the impact of a three-day therapeutic education programme on perceived competence, self-management behaviours (i.e. physical activity, diet and medication) and glycaemic control among adults with type diabetes. A total of 10 participants were included in this randomized, wait list control group trial. The results confirm that therapeutic education may be a powerful healthcare intervention to improve lifestyle and health status of people with type diabetes. We observed that the education programme used in this study generated positive changes in glycaemic control and adherence to physical activity and diet after three months follow-up. Furthermore, the intervention positively impacted participants perceived competence towards physical activity and diet. The latter finding is of particular importance, given that perceived competence has been found to be involved in long-term adherence to self-management behaviours. (Global Health Promotion, 013; 0 Supp. : 94 98). Keywords: therapeutic education, diabetes, perceived competence, physical activity, diet, glycaemic control, self-management More than 50% of type diabetics fail to follow the recommendations prescribed by their healthcare providers (1). Optimal management of diabetes requires that multiple complex behaviours (e.g. dietary adjustment, regular physical activity) be performed on a long-term basis. For this reason, therapeutic patient education (TPE) is often implemented to help individuals with diabetes modify their self-management behaviours and lifestyle, and thus improve their health status. TPE can be defined as an exchange of knowledge, tools, and practice that will address the patient s needs (). In the last decade, meta-analyses (3,4) indicated that TPE had a moderate positive effect on glycaemic control, and thus reduced acute and chronic complications of diabetes. Consequently, TPE is now largely considered as a cornerstone of diabetic treatment. However, TPE is a global term that may encompass a wide range of different intervention modalities. TPE varies substantially across the studies, notably concerning the mode of intervention (e.g. individual versus group), the duration and the number of diabetesrelated topics covered (e.g. diet, medications, blood glucose monitoring, physical activity). Recent systematic reviews (5 7) indicate that TPE efficiency varies strongly from one programme to another. Due to this heterogeneity between studies, it appears necessary to precisely evaluate and identify the characteristics of interventions involved in TPE efficiency. Moreover, despite the numerous arguments in favour of TPE, there is a lack of knowledge about how and why TPE works. In particular, several authors (8,9) highlight the necessity to identify the psychological mechanisms involved in health and behavioural changes generated by TPE. To date, 1. Laboratoire Sport et Environnement Social, Université de Grenoble, France. Correspondence to: David Trouilloud, University of Grenoble, Laboratoire Sport et Environnement Social, BP 53, Grenoble Cedex 9, France. david.trouilloud@ujf-grenoble.fr. Unité d Education Diabétique, CHU Grenoble, Grenoble, France. (This manuscript was submitted on 9 February 01. Following blind peer review, it was accepted for publication on 6 June 01) Global Health Promotion ; Vol 0 Supp. : 94 98; Copyright The Author(s) 013, Reprints and permissions: DOI: /

2 D. Trouilloud and J. Regnier 95 relatively little such research has been conducted. On this point, researchers and practitioners widely recognize that perceived competence (or similar constructs, such as self-efficacy) individuals perceptions of their competence and ability in specific domains (e.g. physical activity) is probably one of the primary predictors of behaviour change resulting from diabetes education (10). People with diabetes perceive themselves to be competent when they feel able to control important health outcomes (11), such as respecting dietary limitations or practising regular physical activity. Perceived competence contributes to motivation and adherence in several ways, notably by shaping aspirations and goals and determining amount of effort and perseverance (1). The importance of perceived competence to diabetes self-care has been highlighted in several studies (13), showing that perceived competence is notably associated with higher adherence, treatment satisfaction and glycaemic control. It is thus largely believed that improving patient perceived competence is a critical pathway to improved diabetes self-management. However, only a small number of studies have concretely explored the role played by perceived competence in the process of TPE efficiency in diabetes care (5). Moreover, these works demonstrated mixed results for interventions that attempt to improve selfmanagement behaviours through improved perceived competence (10). Clearly, more research is needed to evaluate the impact of TPE on perceived competence and its role in behaviour change. The overall aim of this study was to confirm and extend knowledge about TPE effects among patients with diabetes. More precisely, a randomized controlled trial was implemented to evaluate the impact at three months of a three-day TPE programme on perceived competence, selfmanagement behaviours (i.e. physical activity, diet, and medication) and glycaemic control among adults with type diabetes. Methods Procedure and participants This randomized controlled trial was conducted in the diabetes education unit of a French hospital (Grenoble). Participants were recruited on a voluntary basis. Eligibility criteria for this study were physician-confirmed type diabetes, aged between 0 and 80 years, able to speak and read French. A total of 10 participants met the criteria and were randomly assigned to either the TPE group or the control group. The TPE condition consisted of a three-day programme including eight group sessions, each session lasting 3 hours. Sessions were interactive and patient-centered, and consisted of both educational and problem-solving activities on the three main components of diabetes management: diet, physical activity and medication. A group consisted of 5 8 patients. The TPE was conducted by a multiprofessional team including a diabetologist, a dietician, nurses and a physical activity counsellor. In the control condition, patients were placed on a waiting list during a three-month period. The duration of the follow-up was three months. Background characteristics (e.g. demographic, treatments) and outcome measures (glycaemic control, self-management behaviours and perceived competence) were assessed at baseline (T1) and after three months (T). The current study was approved by the consultative committee for the protection of persons participating in biomedical research of Lyon (in France). Measures Glycaemic control (HbA1c) Glycaemic control was measured using HbA1c (glycosylated haemoglobin), an indirect and retrospective measure of average blood glucose over the past three months. HbA1c is widely used as the central clinical indicator of glycaemic control in type diabetes. The normal range for persons who do not have diabetes is %. Higher levels of HbA1c indicate poorer glycaemic control. Diabetes self-management Diabetes self-management behaviours were assessed using eight items from the Summary of Diabetes Self- Care Activities Questionnaire (14). This scale is a brief self-report questionnaire that assesses adherence (over the past seven days) to three aspects of diabetes selfcare: dietary activities (three items), physical activity (three items) and medication taking (three items). Participants indicated the number of days per week that they achieved the behaviour (from 0 to 7). IUHPE Global Health Promotion Vol. 0, Supp. 013

3 96 Table 1. Reliability analysis, means (M) and standard deviations (SD) for glycaemic control, diabetes self management and perceived competence at baseline and three months, by groups Variables Baseline (T1) Month 3 (T) TPE group Control group TPE group Control group Range Alpha M SD M SD Alpha M SD M SD Glycaemic control HbA1c Diabetes self management Diet Physical activity Medication Perceived competence Diet Physical activity Medication TPE: therapeutic patient education Internal reliabilities (Cronbach s alpha) at baseline and three months were satisfactory(see Table 1). Perceived competence in diabetes self-management The Perceived Competence for Diabetes Scale (15) was used to assess the degree to which patients felt that they can manage the three main components of diabetes care: diet, physical activity and medication taking. Each component was assessed using four items. Participants indicated their level of agreement with each item on a 1 7 scale. Internal reliabilities at baseline and three months were satisfactory (see Table 1). Results Data analysis and preliminary results Data on 99 participants (48 women and 51 men; study completion rate = 8.5%) are presented because 16 did not present for follow-up at three months (seven in the TPE group and nine in the control group), and five were considered as outliers (i.e. data that are more than two standard deviations from the mean). On average, participants were aged 56.7 years and had had diabetes for 10 years. At baseline, the mean HbA1c level was 7.54%. Table 1 shows means and standard deviations for outcome measures in both groups at baseline and three months. Data analysis was performed in two steps. Firstly, t-tests were used to evaluate between-condition differences on baseline measures. Results indicate that randomization was effective, as there were no differences between the two groups at baseline on any measure. Next, a series of repeated-measure analyses of variance were conducted in order to assess changes in glycaemic control, self-management behaviours and perceived competence. In these analyses, group (TPE versus control) was used as the between-subject factors and time (baseline versus three months follow-up) as the within-subject factors. Effect sizes are reported as partial eta (which describes the proportion of total variance that is accounted for by the effect in question). Given the focus of this study, only results concerning the interaction time-by-group are presented. Changes in glycaemic control (HbA1c) The results reveal a significant group-by-time interaction for HbA1c [F(1, 97) = 10.5, p < 0.01; η p = 0.10]. Follow-up Scheffe comparisons showed that HbA1c significantly decreased in the TPE group (p < 0.001), whereas it remained stable in the control group (p = 0.55). IUHPE Global Health Promotion Vol. 0, Supp. 013

4 D. Trouilloud and J. Regnier 97 Changes in diabetes self-management Analyses on diabetes self-management measures reveal a significant group-by-time interaction for physical activity [F(1, 97) = 4.10, p < 0.05; η p = 0.04] and dietary behaviours [F(1, 97) = 11.3, p < 0.01; η p = 0.10]. Follow-up Scheffe comparisons indicate that physical activity significantly increased in the TPE group (p < 0.001), whereas it remained stable in the control group (p = 0.59). Similarly, adherence to dietary recommendations improved in the TPE group (p < 0.001), whereas it remained stable in the control group (p = 0.58). There was no significant interaction for adherence to medication treatment (p = 0.61). This lack of significant effect is probably due to a ceiling effect on this variable. Indeed, scores on adherence to medication treatment were already very high at baseline (M = 6.47). Changes in perceived competence Analyses indicate a significant group-by-time interaction for perceived competence towards physical activity [F(1, 97) = 4.76, p < 0.05; η p = 0.05] and dietary behaviours [F(1, 97) = 4.67, p <.05; η p = 0.05]. Follow-up Scheffe comparisons show that perceived competence towards physical activity significantly increased in the TPE group (p < 0.05), whereas it remained stable in the control group (p = 0.99). Similarly, perceived competence towards dietary recommendations improved in the TPE group (p < 0.001), whereas it remains stable in the control group (p = 0.65). There was also a non-significant trend (p = 0.07) for perceived competence towards medication, suggesting an increase for the TPE group. Conclusion The current study was designed to evaluate the impact of a three-day TPE programme on perceived competence, self-management behaviours and glycaemic control among adults with type diabetes. Globally, results reveal that the education programme used in this study generated positive changes in clinical outcome (i.e. an improvement in glycaemic control) and in adherence on two main components of diabetes self-management (i.e. physical activity and diet). Thus, this study confirms that TPE may be a powerful healthcare intervention to significantly improve the lifestyle and health status of people with type diabetes. Moreover, data analyses reveal that this three-day intervention positively impacted participants perceived competence towards physical activity and diet. This result is of particular importance given that perceived competence has been identified as a psychological parameter involved in both the adoption of and longterm adherence to self-management behaviours (13). Taken together, these findings suggest that when TPE manages to enhance patients perceived competence, they are probably more likely to change their behaviours and thus improve their health status. However, because the relatively modest sample size and limited duration of the follow-up represent limitations of this study, additional research is needed to investigate whether the effects can be replicated in different cultural contexts (e.g. in other countries) and can be maintained for a longer time period. Funding This research was funded with the joint help of the National Institute for prevention and health education (Inpes), the High Health Authorities (HAS), the French National Institute of Medical Health Research (INSERM) and Social System of Independents, through a call for projects of the Research Institute in Public Health, in France. Conflict of interest None declared. References 1. Deakin T, McShane CE, Cade JE, Williams RD. Group based training for self-management strategies in people with type diabetes mellitus. Cochrane Database Syst Rev. 005; : CD Mensing C, Boucher J, Cypress M, Weinger K, Mucahy K, Barta P, et al. National standards for diabetes self-management education. Diabetes Care. 005; 8: S7 S Gary TL, Genkinger JM, Guallar E, Peyrot M, Brancati FL. Meta-analysis of randomized educational and behavioral interventions in type diabetes. Diabetes Educ. 003; 9: Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau M. Self-management education for adults with type diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 00; 5: Albano MG, Crozet C, d Ivernois JF. Analysis of the literature on patient education in diabetes: results and trends. Acta Diabetologica. 008; 45: Lagger G, Pataky Z, Golay A. Efficacy of therapeutic patient education in chronic diseases and obesity. Patient Educ Couns. 010; 79: IUHPE Global Health Promotion Vol. 0, Supp. 013

5 98 7. Norris SL, Engelgau MM, Naranyan KMV. Effectiveness of self-management training in type diabetes: a systematic review of randomized controlled trials. Diabetes Care. 001; 4: Glasgow RE. Translating research to practice: lessons learned, areas for improvement, and future directions. Diabetes Care. 003; 6: Peyrot M. Behavior change in diabetes education. Diabetes Educ. 1999; 5: Krichbaum K, Aarestad V, Buethe M. Exploring the connection between self-efficacy and effective diabetes self-management. Diabetes Educ. 003; 9: Williams GC, McGregor HA, Zeldman A, Freedman ZR, Elder D, Deci EL. Promoting glycemic control through diabetes self-management: evaluating a patient activation intervention. Patient Educ Couns. 005; 56: Bandura A. Self-efficacy: The Exercise of Control. New York, USA: Freeman; Williams KE, Bond MJ. The roles of self-efficacy, outcome expectancies and social support in the selfcare behaviours of diabetics. Psychol Health Med. 00; 7: Toobert DJ, Hampson SE, Glasgow RE. The Summary of Diabetes Self-Care Activities Measure. Results from 7 studies and a revised scale. Diabetes Care. 000; 3; Williams GC, McGregor HA, Zeldman A, Freedman ZR, Deci EL. Testing a self-determination theory process model for promoting glycemic control through diabetes self-management. Health Psychol. 004; 3: IUHPE Global Health Promotion Vol. 0, Supp. 013