by Olivia Husband, Doctor of Pharmacy Candidate, University of Mississippi School of Pharmacy
Summary and Analysis of: Rygg LØ, Rise MB, Grønning K, Steinsbekk A. Efficacy of ongoing group based diabetes self-management education for patients with type 2 diabetes mellitus. A randomised controlled trial. Patient Education and Counseling. 2012 Jan;86(1):98–105.
Type 2 Diabetes Mellitus (T2DM) is one of the most prevalent disease states worldwide, and it is projected that the number of people diagnosed with T2DM will continue to increase over the next decade.1 As a student pharmacist, T2DM is something I am interested in, not only because of its high prevalence but the impact a pharmacist can have on the management of people with T2DM. An integral component of T2DM treatment is patient self-care and management, including self-monitoring blood glucose and self-administering insulin injections. Patient education is crucial in ensuring that patients are getting the greatest benefit out of their diabetes treatment regimen. The authors of this study state there was very little evidence regarding the efficacy of local, group-based T2DM education.1
This randomized controlled trial was conducted from May 2006 to November 2008 in central Norway. Participants were patients age 18 or older with a physician confirmed diagnosis of type 2 diabetes mellitus who had at least one general practitioner consultation within the previous three years.1 There was no specific A1C requirement to enter the trial; however, patients who previously attended a diabetes education program in the past 12 months were excluded from the study.1 Twenty general practitioners in the local area were asked to evaluate their patients to identify those who met the inclusion criteria for T2DM group education and then to mail out an invitation to participate in the diabetes management course. Patients who accepted the invitation were then interviewed and randomized into one of two groups: the intervention group, which consisted of two cohorts, hospital 1 and hospital 2, and a control group.1 The intervention group cohorts attended 15 hours of T2DM education delivered over three class sessions. The members of the control group were told they would be placed on a waiting list and would be offered the education program after one year. Control group patients were instructed to continue their self-management practices.1 The intervention received education about T2DM as well as nutrition taught by a diabetes nurse educator who had several years of experience. The education methods used included lectures, interactive skills training with activities, including blood glucose monitoring and problem-solving activities, and group discussion.1 The primary outcomes of the study were changes in A1C (a measure of long-term blood glucose control) as well as patient response to a questionnaire that assessed their knowledge. The outcomes were measured at baseline, at 6 months after the education program, and again at 1-year post-program.1 The results were analyzed using both per protocol and intention to treat analysis.1
There were no statistically significant differences between the intervention and control groups in regards to primary outcomes at 6 months.1 But, after 1 year, the control group had a worsening of their A1C level from baseline of 0.3% while the intervention group maintained their baseline A1C (p=0.032).1 All groups improved their diabetes knowledge after 12 months, but the patients in the intervention group significantly greater improvements in diabetes knowledge when compared to the control group.1 The intervention group also had a higher level of treatment satisfaction at 6 months, but not at 12 months.1 There was also a significant increase in the number of participants who avoided fatty foods and regularly self-monitored their blood glucose (p=0.027) among members of the intervention group.1 Although the intervention group improved their knowledge of self-management of T2DM, their quality of life decreased from baseline over the course of 12 months (p=0.005).1 This was not the case for the control group, as their quality of life scores remained unchanged when compared to baseline.1 I think the decline in quality of life in the intervention group might be due to the more intensive monitoring and, ironically, with greater knowledge, more anxiety about the negative effects of diabetes.
Many of the participants in the study had a baseline A1C that was below the recommended treatment goal, and this is a major limitation of this study. To offset this limitation, a sub-group was performed for the subset of patients with an A1C greater than 7.7% at baseline.1 These participants had poorer glycemic control at baseline, so they reaped the most benefit from the T2DM education program. One way the investigators could have prevented this limitation is to have a baseline A1C requirement for participants to enter the study. I think it is important to note the general decline in patient quality of life within the year following the education program perhaps due to more stress and anxiety related to the management of their T2DM. The program consisted of 15 hours of education across 3 sessions which are very long sessions and it’s hard to absorb that much information. This could have been avoided if the 15 hours was separated into more sessions. The sessions themselves seemed to use an effective combination of lectures, activities, and discussions, with breaks provided for participants.1 I think overall, the methods of this study were appropriate because the investigators measured both glycemic control as well as patient knowledge after attending the classes. However, I think they should have scheduled shorter sessions and perhaps included sessions about stress reduction strategies.
Several studies have analyzed the benefits of providing group-based type 2 diabetes management education and most have produced positive results. Participants saw an improvement in their glycemic control. In one analysis patients were more likely to see improvement when the program was taught by a pharmacist rather than a different healthcare professional.2 In most other studies, participants also saw an improvement in their overall quality of life, which was not seen in this study.1-3
This study shows that patient education about type 2 diabetes mellitus and self-care is an essential element of its management. This study reinforces the importance of patient education while providing insight on how to structure it. Learning how to manage a disease can be overwhelming, so it is important to address the stress and anxiety that can occur.
References
- Rygg LØ, Rise MB, Grønning K, Steinsbekk A. Efficacy of ongoing group based diabetes self-management education for patients with type 2 diabetes mellitus. A randomised controlled trial. Patient Education and Counseling. 2012;86:98–105.
- Mikhael EM, Hassali MA, Hussain SA. Effectiveness of diabetes self-management education programs for type 2 diabetes mellitus patients In middle east countries: A systematic review. Diabetes Metab Syndr Obes. 2020;13:117-138.
- Kumah E, Sciolli G, Toraldo ML, Murante AM. The diabetes self-management education programs and their integration in the usual care: A systematic literature review. Health Policy 2018;122:866–77.