In Brief
In an attempt to make education a nonstop process, the University of Turin in Italy developed an education and clinical care model called Group Care for patients with type 2 diabetes. Through this model, a series of seven sessions facilitated by a nurse, a dietitian, and a pedagogist are matched with clinical practice in the diabetes clinic. A primary goal of the sessions is to transform people with diabetes into self-educators. A randomized, controlled trial documented improvements in metabolic outcomes, quality of life, and health behaviors for participants in Group Care compared to a control group. A second multicenter trial demonstrated that Group Care can be effectively reproduced in other medical clinics. This article describes the Turin experience, from development of the program through its evaluation.
Diabetes is one of the most common chronic disorders in the Western world. Type 2 diabetes affects large numbers of people from a wide range of ethnic groups and at all social and economic levels. Although the onset of type 2 diabetes is usually less dramatic than that of type 1 diabetes, both forms of diabetes carry a risk of multiple disabling, yet potentially preventable, complications.1,2 Diabetes greatly increases the risk of cardiovascular disease, including coronary heart disease and stroke, and is the primary cause of death in industrialized countries.
It is now clear that type 2 diabetes is a progressive condition and ought never to be considered the “mild” form of diabetes. It should be taken seriously, and the objective of treatment should be to achieve and maintain long-term near-normal blood glucose, lipid, and blood pressure levels.
It is also recognized that adoption of self-management skills (i.e., the learned ability to perform an act competently) by people living with diabetes is necessary to enable them to manage their disease well. Effective management lies almost entirely in the hands of patients who live with the condition. Optimal management requires good control of blood glucose, good nutrition and food planning, a physical activity program, and compliance with medication and monitoring. However, a professional-centered approach based on the medical model is still traditionally used.
Self-management education for patients with diabetes has changed, however. Patients are no longer passive spectators during education sessions. They are actively involved in the learning process, the determinants and objectives of which depend primarily on them.
Education is a dynamic, lifelong process that requires a multidisciplinary, professional team of educators to provide the best opportunity for improvements in patient outcomes. In particular, psychologists and educators are necessary along with other health care professionals possessing excellent decision-making and managerial skills.
Diabetes education has been definitely acknowledged as an essential component of treatment, especially since the results of the Diabetes Control and Complications Trial1 and the U.K. Prospective Diabetes Study2 were reported. However, new models and management strategies must be found to meet the growing needs of patients living with diabetes while simultaneously meeting standards of care and making effective use of resources.
Recent systematic reviews and meta-analyses have stressed the need for appropriate educational methodologies to modify patients' lifestyles.3–7 As a result, psychological interventions have been developed to improve patients' problem-solving skills, thus reducing their anxiety. However, real improvements in quality of life seem to be possible only after 18 months of such interventions.3,6 Patients usually have improvements in A1C values during the first 1–3 months of a program but then revert to previously higher values if they are not enrolled in a follow-up program.4,5 Lifestyle modifications reduce progression from prediabetes to type 2 diabetes7 and improve metabolic control in patients with diabetes, thus preventing micro- and macrovacular complications.1,2,8 However, even in people with type 2 diabetes who are intensively treated, metabolic control tends to deteriorate because the disease progresses toward β-cell failure.2 Thus, a clinical approach designed to achieve and maintain the benefits of improved health behaviors while delivering appropriate pharmacological treatment is necessary.4
The Turin Experience
In January 1996, in response to the need for a new clinical approach, the University of Turin in Italy launched an effort to develop a new education and clinical care model for patients with type 2 diabetes. The new model, called Group Care, stressed that health care providers must relentlessly take care of people who need help. This does not mean forcing patients to do what the health care providers would like them to do, but rather helping patients in the process of attaining autonomy—becoming self-sufficient and self-confident enough to manage their diabetes self-care. Because diabetes is a long-lasting disease, adequate time and appropriate self-care behaviors are very important in the therapeutic relationship between health care providers and patients. Long-term education and care are based on unconditional support as well as shared risks and responsibilities.
Currently, Group Care sessions are held in the Laboratory for Applied and Experimental Clinical Pedagogy, which was built through funds granted by the European Federation for the Study of Diabetes and the European Association for the Study of Diabetes. The laboratory is both a diabetes research facility and a care center, where nurses and dietitians are trained and work together with other trained educators and diabetes specialists. To achieve this, education sessions are matched with daily clinical practice in the diabetes clinics.
The laboratory is intended to be both a learning and a training center, where people can get to know each another and human relationships come first. The organization of the clinic was unclear at the beginning, with many different physicians, each having a different clinical and educational approach. Physicians and nurses had various roles and tasks inside the clinic, and, as a result, patients with either type 1 or type 2 diabetes were rarely treated by the same physician for their ongoing care. It was decided to focus on a methodology for providing care for patients with type 2 diabetes, primarily because of the large number of these patients who needed help.
There was a great interest in the need for a new educational model and working strategy that would help patients change their lifestyles, using more appropriate health behaviors to improve metabolic control and quality of life. The clinic had not previously promoted an effective education program. Indeed, in most cases, patients were not considered as people who had their own feelings and experiences to share. The disease and its symptoms were the only aspects that mattered. Therefore, to develop the new model, it was decided to collect the needs, impressions, and experiences of people with type 2 diabetes.
Preparing for a New Education Model: Patients' Perspective
The educator decided to observe the clinical setting from patients' point of view, and to do this, spent 6 months in the waiting room of the clinic. During this time, she could listen to and document patients' opinions, feelings, fears, and beliefs. By listening to conversations among patients, she could systematically collect patients' personal remarks and individual beliefs about the disease. It became clear from this experience that patients had different ways to talk about their diabetes but that every word was hiding common beliefs, habits, experiences, and traditions.
Among patients' descriptions of diabetes were:
“… [diabetes] is a nasty disease!”
“… [diabetes] is like a woodworm boring in the silence.”
“It is like a thief robbing your home … you don't realize it, but you find out that you've lost everything.”
These types of descriptions revealed that patients were afraid of diabetes and perceived it as something bad. It was likely that information about diabetes had been delivered to them superficially and that they may have been threatened with its consequences during consultations. Thus, patients were not able to understand diabetes and now felt confined to a no-escape zone.
One patient was heard asking another who had just seen the doctor, “What did he tell you? Did he say that's your fault?” Thus, it appeared that patients attending the clinic were afraid that they would be blamed for their behaviors and for their disease.
Unfortunately, some physicians and nurses are accustomed to criticizing their patients and justify this behavior as a way to motivate patients. Patients often do not understand their physicians' criticisms, nor do they agree. The attitude of motivating people by blaming them is based on an incorrect theory concerning the functioning of the human psyche. In actuality, human beings tend to ignore information and knowledge contradicting their behaviors whenever they believe that it is too difficult for them to act in a different way. This phenomenon is known as a “cognitive dissonance.” From conversations heard in the busy waiting room, the clinic's health care providers began to understand many things about what it is like to live with a chronic disease.
Diabetes is indeed a chronic disease, and patients with diabetes usually need to change their lifestyle, eating habits, beliefs, and traditions to manage it well. This requires time and a shared set of ideas and words whose meaning must be understood by both patients and their health care providers. When health care providers use technical words or focus on the negative effects of the disease, this often leads to ineffective care and can have dangerous consequences. However, it often takes time for physicians and other health care providers to understand and change their educational approach and interventions when they deal directly with patients.
It came to be understood that a cognitive and emotional dissonance existed between what health care providers said about diabetes and the way patients perceived their disease. It was similar to two people speaking in different languages; different meanings were given to words and notions by each party. The task, then, became helping the two parties (patients and providers) communicate with each other more effectively. It seemed necessary to foster a therapeutic education program based not only on treatment but also on patient-to-provider human relationships. Crucial issues and the strategies needed to solve them must be detected together. This can be demanding, but it is not impossible.
The clinical team realized that patient education often was being provided on an irregular and unstructured basis only when specific needs arose. Education sessions were neither structured and scheduled nor monitored and assessed for effectiveness. To improve this situation, the new, patient-oriented approach to diabetes education had to:
Encourage people to change;
Improve human relationships;
Establish deadlines to reach goals;
Create a monitoring and evaluating system to assess interventions;
Foster patients' self-confidence and improvements using a dynamic interactive process;
Stress the importance of listening to patients without prejudice; and
Include training of the professional team based on shared methods and goals.
Group Care: A New Model
Group Care education interventions are based on a new, interactive patient-to-provider approach that replaced the one-on-one traditional relationship. Patients participate in a session of Group Care every 3 months. This frequency was chosen so that the education sessions would correspond to the clinic's scheduling of patients with type 2 diabetes for routine follow-up visits, which occur every 3 months.
Education must always take into account the participants' social and cultural characteristics. People involved in an educational intervention must also educate themselves. They must understand the cultural and social settings in which people live and work and take advantage of available resources aimed at specific patient subgroups. Based on previous experiences, the Group Care education program consists of a series of seven sessions that are facilitated by a nurse, a dietitian, and a pedagogist and last no longer than 1 hour each. The sessions focus of the following topics related to diabetes self-care and healthy lifestyles:
Session 1: Exploring the connection between eating habits, body weight, and diabetes
Session 2: Exploring eating habits by choosing foods from a sample menu to encourage thinking about ways of eating
Session 3: Looking at one meal and then cooking a better one
Session 4: Shopping, including patients choosing their own foods and explaining their choices
Session 5: Understanding the link between diabetes control (A1C) and individual lifestyle behaviors, including physical activity
Session 6: Discussing the importance of regular follow-up and individualized care
Session 7: Avoiding complications, highlighting the meaning of prevention and healthy behaviors in everyday life
Each session is divided into four parts: welcoming patients, teaching, exploring real-life situations, and concluding. The Group Care sessions last for 2 years and then begin again, so that patients can get continuously updated information. The programs are continuously changing as a result of contributions from active learners, both patients and facilitators.
Health care professionals learn to emphasize the importance of individual experiences during group sharing and to identify the group's unique and ever-changing dynamics and needs. The groups are characterized by active involvement, communication, interaction, creativity, transformation, and a deep respect for all members. People involved in an educational intervention must become educators of themselves.
Teaching methodologies focus on facilitating learning about various topics while emphasizing both cognitive exercises (e.g., simulations, role-playing games, and moderated debates) and psychomotor abilities (e.g., hands-on workshops and even walking together during the shopping experience).
An educational kit has been patented. It is a big box containing various tools to be used during each session. There are artificial food items (e.g., fruits and vegetables, meats, fish, noodles, breads, cakes, milk, sugar, wine, beer, oil), graduated containers, tools for diabetic foot care (e.g., different kinds of shoes, socks, and soaps), other tools for personal hygiene, an eye model, a heart model, and a colorful information booklet. Procedures for using the training aid and organizing sessions are carefully described.
Flexibility is essential throughout the educational process. Indeed, every educational intervention must be tailored to fit the group to whom it is delivered. The same topics must be treated in different ways to take into account the needs of the patients involved and avoid possible monotony and boredom. It is also particularly important to focus on individuals, helping them discover and share their potentially huge personal resources. When this is accomplished, patients take control of their diabetes and begin to enjoy a healthier lifestyle.
Finally, the connection between “time” and “learning process” is very important. We cannot change patients' cognitive structures, but we can try to identify the right time for them to learn, which can raise their self-confidence.
Group Care has been well accepted by many participants, as evidenced by the following representative comments:
“When my disease, diabetes, caught me, I couldn't really believe I was ill. Now, thanks to group sessions and your different way of conducting examinations (talking to a nurse), we have more time to learn and understand.”
“With time, over the years, I've learned a lot thanks to people in my group, and all the people sitting around have helped me, too.”
“Every single person I met taught me something new, new solutions, old types of wisdom … I learned even from people who could neither write nor read. They all made me a better human being.”
A 4-year study evaluating the Group Care program showed that participants were able to perceive their disease in a different way and learned to be more self-sufficient in managing diabetes as a result of the program.9 Group Care facilitates the learning process; members do not feel lonely; they can share opinions with others and learn from them; they know there's somebody waiting for them and vice versa; they establish new relationships; they feel at ease; and they are themselves and perceive that the others are really interested in what they are saying. All this has a positive effect in terms of their quality of life, health conditions, individual approaches to diabetes, and ability to take responsibility for making changes. Each group member counts, regardless of financial resources, social origins, or education level.
Diabetes is a social disease in that it concerns not only patients but also their families and friends. As a result, when these people change their life-style, others are always involved.
More comments on the positive social effects of this experience included:
“I am more and more happy to come here … . I came for the first time many years ago, and it makes me feel so good to look at you … so young and beautiful … it's a bit like when I go visiting relatives. Well, I always look forward to attending the group sessions. I really need to come here because here I feel fine and happy.”
“At the beginning, I thought something terrible had happened to me: diabetes, restrictive diet … . Today, I know I can make it, together with my friends.”
Validating the Group Care Education and Clinical Model
The goal of the Group Care model is to offer effective care and education to patients through an intervention that diabetes health care teams could easily put into practice. In 1998, it was noted that no clinical trial in the field of education had been conducted and that teaching programs, objectives, and methodologies appeared to be totally insufficient.10 Because so little research had been done on diabetes education, Group Care was a pioneering effort that needed sound scientific evaluation. To do so, the Turin team opted to conduct a long-term randomized, controlled clinical trial. Rigorous procedures were adopted to ensure the trial's quality and validity, and published data from the trial have validated the Group Care model.9,11–14
Study design
Patients with type 2 diabetes (n = 120) were randomized into Group Care or the control group. Selected patients had all been attending the clinic for > 1 year, and none had received previous structured and continuous therapeutic education. Some patients were illiterate, elderly, retired, or homemakers, and all patients involved in the study signed the informed consent. The Group Care random sample (n = 60) was divided into groups of 9–10 people for group sessions, and the control group (n = 60) continued to receive the usual one-on-one treatment.
Patients in Group Care attended education sessions along with their usual medical appointments every 3 months. At each visit, patients had their body weight, blood glucose, and A1C levels measured and then joined their groups for the diabetes education session. Once a year, these patients were screened for diabetes complications. They had laboratory tests for total cholesterol, HDL cholesterol, triglycerides, microalbuminuria, and complete blood count; their blood pressure was measured; and they were given diabetic retinopathy and foot examinations. All patients' medical records and test results were examined by a physician before group education session, and after each session, patients could decide to see the physician for a brief individual visit. The Group Care educational interventions were documented in the patients' case records and were based on the new, interactive patient-to-provider approach that had replaced the one-on-one traditional approach.
Patients were followed for 5 years. Clinical and metabolic data were collected, and patients' quality of life, understanding of diabetes, and life-style behaviors were assessed through validated questionnaires. These assessments were important because no literature existed regarding the impact of therapeutic education on such psychometric indicators in such a heterogeneous group of patients with type 2 diabetes. Of particular interest was identifying the extent to which education could help patients develop a new perception of their disease and find new ways to live with it.
Study results
At an average of 51 months, 56 patients managed with group education and 56 control patients managed with individual consultations (usual care) were evaluated. A1C increased in the control group but not in the Group Care patients (P < 0.001), in whom BMI decreased (P < 0.001) and HDL cholesterol increased (P < 0.001). Quality of life, knowledge of diabetes, and health behaviors improved with Group Care (P < 0.001) and worsened among control patients (P = 0.004 to P < 0.001). Dosage of hypoglycemic agents decreased (P < 0.001) and retinopathy progressed less (P < 0.009) among the Group Care patients than among control patients. Diastolic blood pressure (P < 0.001) and relative cardiovascular risk (P < 0.05) decreased from baseline in both patient groups.13
The ROMEO Trial: Reproducing Group Care Education
After the initial success of Group Care education in Turin, the program was instituted at 13 other diabetes units in Italy. The Rethink Organization to iMprove Education and Outcomes (ROMEO) trial was conducted to determine whether the results of Group Care could be reproduced in other clinics.15
Study design
A total of 815 patients with type 2 diabetes of ≥ 1 year of known duration, aged ≤ 80 years, from the 13 diabetes units were randomized to either Group Care or traditional one-on-one care (control group). Body weight, fasting glycemia, A1C, and blood pressure were measured every 3 months; creatinine, total cholesterol, HDL cholesterol, and triglycerides were measured yearly. Health behaviors and quality of life were measured by validated questionnaires at baseline and at 2 and 4 years. Knowledge of diabetes was measured at baseline and at 4 years.
Group sessions and individual visits were performed every 3 months by the same team. The Group Care patients participated in seven 1-hour sessions that were repeated once over the 4 years. Education involved group discussions, hands-on activities, problem-solving, real-life simulations, and role-playing. All patients received individual physician consultations at least yearly or whenever health care professionals felt it was necessary or on request by patients.
Trial investigators were trained in the Turin laboratory on principles of adult education, how to do an analysis of the Group Care group, and how to transfer Group Care to their clinics. An operating manual, teaching materials, logistical support, and supervision were provided to the participating clinics throughout the study. The control groups' individual visits were based on local clinical practices.
Study results
In Group Care subjects, BMI, fasting glycemia, A1C, total and LDL cholesterol, triglycerides, and systolic and diastolic blood pressure decreased from baseline to 4 years, while HDL cholesterol increased (P ≥ 0.001 for all) and creatinine did not change.15 In control group subjects, BMI, A1C, triglycerides, and creatinine increased, whereas HDL and LDL cholesterol and systolic blood pressure did not change and diastolic blood pressure decreased. Health behaviors, quality of life, and knowledge improved in Group Care subjects (P ≤ 0.001 for all). Health behaviors did not change in control subjects, and quality of life and knowledge decreased.
The proportion of patients reaching individual therapeutic target levels for A1C, systolic blood pressure, diastolic blood pressure, and LDL cholesterol at 4 years increased from baseline, and the number of patients meeting all targets doubled.15
Conclusion
Lifestyle intervention requires the ability to deliver continuing patient education and care with measurable outcomes without increasing clinic workload. In the Turin experience, it was possible to reorganize routinely delivered medical care practices for patients with type 2 diabetes and to implement Group Care, a feasible and cost-effective approach that improved metabolic control and quality of life.9,12–14
ROMEO, a multicenter, controlled trial, showed that Group Care is transferable to other diabetes centers and confirmed its efficacy. A1C and lipids improved, and, at study end, the percentage of Group Care patients achieving currently recommended clinical targets increased from baseline, while the opposite happened to control subjects. This occurred without additional medication and strongly suggests that healthier behaviors were induced by Group Care.15,16 As the acronym ROMEO suggests, Group Care requires reallocation of tasks, roles, and resources and a change in providers' attitudes from the traditional prescriptive approach to a more empathic role of facilitator.
Previous studies evaluating education in diabetes management varied in approach, were shorter in duration, and measured fewer outcomes.17 The Diabetes Education and Self-Management for Ongoing and Newly Diagnosed study, the only other multicenter trial of education in patients with type 2 diabetes, did not register improvements in A1C or quality of life over the 1-year follow-up in newly diagnosed patients.18 In contrast, continuous interactive patient-centered education through Group Care is reproducible and improves diabetes management and outcomes.
Based on 11 studies with 1,532 participants, a Cochrane review concluded that group-based training for self-management strategies in people with type 2 diabetes is effective, as evidenced by improvements in fasting blood glucose levels, A1C, and diabetes knowledge and reductions in blood pressure, body weight, and the need for diabetes medications.17 Group Care interventions are an emerging application for diabetes care, and the method is expanding because it involves the areas of diabetes counseling, psychosocial support, diabetes education, and medical treatment.19 Although more research is needed to continue testing the efficacy of Group Care compared to individual treatment methods, we think that part of the rocky road to the full recognition of group medical appointments as essential in good care for type 2 diabetes has been successfully traveled.
