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Psychosocial Predictors of Relapse Among Diabetes Patients: A 2-Year Follow-Up After Inpatient Diabetes Education

Received Jan. 21, 2003; revision received Oct. 28, 2003; accepted Nov. 24, 2003. From the Tokyo Institute of Psychiatry; Musashino Red Cross Hospital; Sophia University; and Tokyo Women's Medical College. Address correspondence to Ms. Akimoto, 1-15-6, Hazawa, Nerima-ku, Tokyo, 176-0003, Japan; Mrakmt{at}aol.com (e-mail).

ABSTRACT

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In a 2-year follow-up study of diabetes patients (N=309) who received 2 weeks of inpatient diabetes education, the authors investigate the relationship of several demographic, clinical, and psychosocial factors with relapse, defined as the worsening of glycemic control. The patients with no improvement in glycemic control after diabetes education were more likely to have higher scores on the depression subscale of the Profile of Mood States, compared to the patients with improvement. Kaplan-Meier survival analyses showed that patients who had no prior diabetes education, whose meals were prepared by their spouses, and who had less social support were more likely to relapse and relapsed within a significantly shorter period of time than those who had prior diabetes education, cooked for themselves, and had more social support.

INTRODUCTION

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Diabetes is a chronic disease that requires a lifetime of consistent and careful daily self-management. Failure to adhere to strict self-care regimens may lead over time to diabetic complications, such as retinopathy, nephropathy, neuropathy, and coronary heart disease.^1,2

The role of psychosocial factors in the long-term outcome of diabetes patients has been widely studied and well documented.^3–17 Previous studies have addressed a wide range of psychosocial factors at the personal, social, and community level, including the presence of psychiatric conditions³ (especially depression^4,5), health beliefs and attitudes,^6–8 stress and coping styles,^9–11 social support,^12–14 and family and social environment.^15–17

Education has been considered an important part of diabetic treatment. Education has been generally effective in increasing patients' knowledge about the disease, but it has not been as effective in changing self-care behavior.¹⁸ The research literature has shown that short-term and information-based educational programs are often ineffective in enhancing and sustaining treatment adherence, as the behavior of recipients of such programs deteriorates over time.¹⁹

A few studies have addressed the question of who benefits from diabetes education by examining the relationship between psychological factors and the effects of education. Wooldridge and associates⁷ conducted a 12-month follow-up after a diabetes education program that included patients with both type 1 and type 2 diabetes. They found no significant correlation between health beliefs and hemoglobin A_Ic (HbA_Ic) (the major fraction of glycosylated hemoglobin) values (a measure of glycemic control) or between self-reported compliance and HbA_Ic values. Rubin et al.,²⁰ on the other hand, followed both type 1 and type 2 diabetes patients for 6 months and found that those with low levels of emotional well-being, poor self-care patterns, or poor glycemic control benefited the most from educational programs. In a 3-year follow-up study, Bott et al.²¹ found that the following factors were significant predictors of glycemic control: HbA_Ic values before the educational intervention, smoking, diabetes-related knowledge, blood glucose monitoring in the home, age at onset of diabetes, perceived coping abilities, and insulin C-peptide levels. Their study, however, was limited to type 1 diabetes patients who participated in intensive treatment and teaching programs. O'Connor and his research team²² found that patients who had diabetes for 2 years or less and who had poor baseline glycemic control (HbA_Ic values greater than 10%) were more likely to have significant positive change in the glycemic index in response to educational programs. Their follow-up study, however, was based on HbA_Ic values obtained 2 months after the educational intervention, which reflect only the acute effects of outpatient education. The study did not investigate whether the educational program helped patients to maintain good glycemic control over longer periods.

We have observed clinically that some patients have trouble assimilating what they are taught in educational programs. In addition, other patients seem to assume responsibility for their self-care with relative ease in the beginning of treatment but fail in the long run. A meta-analysis of the effect of self-management education for adults with type 2 diabetes²³ showed that the net changes in glycosylated hemoglobin values at the 1–3 month follow-up were particularly diverse. The authors noted that this finding may be partly explained by patient factors, such as psychosocial mediators. Also, Glasgow and Eakin²⁴ stated that patients who require particularly intensive intervention may include those with major psychological disorders, such as clinical depression. On the other hand, Glasgow²⁵ also emphasized the role of social environment factors in diabetes self-management.

The aim of the current study was twofold: 1) to determine which psychosocial factors directly and immediately influence patients' ability to learn diabetic self-care and 2) to follow the longitudinal course of patients' glycemic control in order to examine the relationship between these factors and the maintenance of glycemic control. We hypothesized that patients who do not benefit from education are more likely to have psychiatric problems or particularly ineffective coping styles. We also hypothesized that those who initially benefit by achieving lower HbA_Ic values but who return to their initial glycemic state tend to do so for other reasons, which may go beyond personal factors.

METHOD

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Subjects
The subjects were patients with a diagnosis of type 1 or type 2 diabetes who were admitted to Musashino Red Cross Hospital, one of the largest general hospitals in the suburbs of Tokyo, between April 1995 and August 2000, for an inpatient diabetes treatment and education program. The majority of patients admitted to Musashino Red Cross Hospital come from the mid-western area of the capital. After informed consent was obtained, 535 patients completed a series of questionnaires that measured psychosocial factors affecting the course of diabetes. Owing to an administrative error, follow-up HbA_Ic values were not obtained for 183 subjects, and they were omitted from the database. Subjects were also excluded if they had comorbid medical or psychological conditions, including schizophrenia (N=4), borderline personality disorder (N=1), cancer (N=4; death occurred in three cases), secondary diabetes (N=3), dementia (N=2), hepatitis C treated with interferon (N=2), impaired glucose tolerance (N=1), and death (N=1). Other subjects were dismissed because their data were incomplete (N=7) or because they were readmitted within the study period (N=18). Thus, the analyses are based on data for a total of 309 subjects.

The Inpatient Diabetes Education Program
The hospital's 2-week inpatient diabetes education program consists of 14 hours of lectures on the causes of diabetes, acute and chronic complications, treatment, diet, exercise, medication, and other aspects of self-management, including foot care. The lectures are given by the hospital staff, including physicians, nurses, a dietitian, and a pharmacist. In this comprehensive program, which covers most areas involved in diabetic self-management, diet is particularly emphasized, and four 1-hour sessions are dedicated to nutrition and meal planning. After the lectures, patients are interviewed daily by a charge nurse to check their level of understanding, and the nurse provides complementary information and training if necessary. The techniques for self-monitoring of blood glucose and/or insulin injection are taught individually and supervised until each patient masters these skills. Although there are no exact criteria for admission to the inpatient diabetes education program, physicians strongly recommend the program to their patients whose HbA_Ic values are more than 8.0% for two or three consecutive months and for patients who require hospital treatment for diabetic complications.

Measures
The psychosocial measures used in the study included the Stress and Coping Inventory,^26,27 the Toronto Alexithymia Scale,^28–30 the NEO Five-Factor Inventory,^31,32 and the Profile of Mood States (POMS).^33,34 All of the questionnaires had been translated and validated in Japanese. The Stress and Coping Inventory, developed by Rahe, has four subscales that measure coping in terms of health habits, social support, responses to stress, and life satisfaction. The social support subscale provides a total social support score and scores in three categories: existence (existence of an individual's social network), utilization (the utilization of this network), and perception (a person's perception of the readiness of the network to come to their aid). In addition to total positive and negative stress response style scores, scores for different coping styles (silver-lining, problem solver, blame, wishful thinking, and social support) are calculated. The Stress and Coping Inventory also provides life satisfaction scores in the following areas: health, work, family, and community. The Toronto Alexithymia Scale is a 20-item questionnaire that measures degrees of emotional regulation. It has three factor scores: factor 1, which measures difficulty in identifying feelings; factor 2, which measures difficulty in describing feelings; and factor 3, which measures externally oriented thinking. The NEO Five-Factor Inventory is a shortened Japanese version (60 items) of the NEO Personality Inventory Revised developed by Costa and McCrae on the basis of the Big Five model of personality. The five factors assessed by the NEO Five-Factor Inventory are neuroticism, extroversion, openness to experience, agreeableness, and conscientiousness. The POMS is a 60-item questionnaire that examines mood states. In addition to providing a total mood score, the POMS has subscales that measure depression, anger, tension and anxiety, vigor, fatigue, and confusion.

HbA_Ic values were used as a measure of glycemic control. We used the HbA_Ic values measured closest in time to admission as baseline data. If the subject's HbA_Ic had not been measured before admission, we used the value assayed during the patient's 2-week hospitalization. Follow-up HbA_Ic values were assayed during each outpatient visit. The frequency of outpatient visits and therefore of HbA_Ic testing varied from patient to patient, ranging approximately from one test every 2 weeks to every 2 months, resulting in a variance in the number of available follow-up HbA_Ic values.

Statistical Analysis
The ultimate purpose of diabetic education is to enhance patients' ability to maintain good glycemic control over a long period of time, thus improving their quality of life. We calculated length of time as the number of months before relapse, and we estimated the rate of relapse with the Kaplan-Meier statistic. Relapse was considered to have occurred if the patient's HbA_Ic value, after a decrease during the inpatient diabetes education program, returned to or became higher than the preintervention value. The time frame for relapse analysis was the number of months between improvement (the point when the HbA_Ic value became lower than the preintervention level) and relapse (or at 24 months for patients who did not experience a relapse). If follow-up assessments, which included outpatient visits and monitoring of HbA_Ic levels, were discontinued (because the patient changed hospitals or dropped out of treatment or for other reasons unknown to the authors), the number of months between the measured improvement and the last assessment date was included in the data. The survival curves were compared by using the log-rank (Mantel-Cox) chi-square test. Cox regression analysis was then applied to identify independent prognostic factors. SPSS for Windows, version 10.0 (Chicago, SPSS), was used for all analyses. All statistical tests were two-tailed, with significance set at p<0.05.

RESULTS

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Study Participants
Table 1 shows the demographic and clinical characteristics of the study group (N=309). We compared the characteristics of the study group with those of the 226 subjects who were excluded from the analyses (N=183 because of missing follow-up data, N=43 for other reasons). The two groups were comparable, except for the percentage of patients with type 1 diabetes, the percentage of patients who used insulin, and the duration of diabetes. Compared with the subjects who were excluded, the study group included fewer type 1 diabetes patients (6.5%, compared with 15.7%; ²=9.63, df=1, p<0.01), included more patients who used insulin (40.5%, compared with 19.3%; ²=19.21, df=1, p<0.001), and had a longer mean duration of diabetes (8.88 years, compared with 4.74 years, t=5.00, df=432, p<0.001).

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TABLE 1. Characteristics of Patients With Type 1 and Type 2 Diabetes (N=309) Who Participated in a 2-Week Inpatient Diabetes Education Program

Change in HbA_Ic Values
The patients' mean HbA_Ic values at monthly intervals were plotted (Figure 1). A maximal improvement was observed between the postintervention point (immediately after the 2-week inpatient diabetes education program) and the 3-month follow-up, suggesting an effect of inpatient treatment and education. Thereafter, the mean HbA_Ic value remained constant and, after 12 months, tended to increase gradually.

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FIGURE 1.  Hemoglobin AIc Values Over a 24-Month Follow-Up Period of Patients With Type 1 and Type 2 Diabetes (N=309) Who Participated in a 2-Week Inpatient Diabetes Education Program

The long-term effect of education was examined by repeated-measures analysis of variance of HbA_Ic data at baseline (before the inpatient education program), after the program, and at 3-, 6-, 12-, and 24-month follow-ups. There was a significant main effect of the inpatient diabetes education program (F=20.40, df=5, 165, p<0.001). Post hoc comparisons by means of t tests with Bonferroni's adjustment revealed that in general, HbA_Ic values decreased from baseline (before the inpatient education program) to 3 months after the program and the effect of the education program continued until the 24-month follow-up.

Factors Associated With Absence of a Significant Effect
Despite this overall trend, there were patients who failed to achieve a decrease in preintervention levels of HbA_Ic at the 3-month point. To explore the reasons for this failure, subjects with no improvement in HbA_Ic values by 3 months were categorized as the noneffective group. Subjects with HbA_Ic values that were lower than the preintervention level were deemed the effective group. The data on clinical and psychosocial variables for the effective group (N=274) were compared with those of the noneffective group (N=35) by using Student's t tests. The noneffective group had a significantly lower mean preintervention HbA_Ic level (t=3.88, df=306, p<0.001) and a significantly higher mean POMS depression subscale score (t=2.13, df=288, p<0.05), compared with the effective group. No other significant differences in clinical and psychosocial variables, including the type of diabetes (type 1 versus type 2), were found between the two groups.

Factors Associated With Relapse
At the 24-month follow-up, 113 (36.3%) patients had not relapsed, that is, their HbA_Ic values were lower than their preintervention levels. The remaining 296 (63.7%) patients either relapsed at some point during the 24 months or were dropped from the data analysis for reasons previously mentioned.

To explore factors contributing to long-term maintenance of glycemic control, namely the prevention of relapse, we used Kaplan-Meier analysis to investigate the relationship between each clinical and psychosocial factor and relapse. For each psychosocial variable, the subjects in the effective group were divided into high scorer and low scorer groups according to the median score on the instrument used to measure the variable, including the Toronto Alexithymia Scale (the cutoff score was above 60), the POMS subscale scores and total mood score, and the subscale scores of the Stress and Coping Inventory.

Subjects whose meals were prepared by their spouses had a significantly greater relapse rate than those who cooked for themselves (log rank ²=6.87, df=1, p<0.01). There was, however, no significant difference in relapse rates between men and women. Patients whose total social support score was low had a significantly greater relapse rate than those with a high total social support score (log rank ²=14.85, df=1, p<0.001) (Figure 2). In addition, patients who participated in the inpatient diabetes education program for the first time had a significantly greater relapse rate than those who had received diabetes education more than twice (log rank ²=6.02, df=1, p<0.05). Cox regression analysis demonstrated that the total social support score was the most important predictor of relapse (²=4.74, p<0.03) and that the effect of having prior experience in the inpatient diabetes education program just failed to reach statistical significance (p=0.10). Similarly, the factor of who cooks for patients just failed to reach statistical significance (p=0.19).

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FIGURE 2.  Time to Relapse Over a 24-Month Follow-Up Period After Participation in an Inpatient Diabetes Education Program for Diabetic Patients With High and Low Levels of Total Social Supporta aTotal social support was measured with the social support scale of the Stress and Coping Inventory.

DISCUSSION

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Glycemic control of the participants of the inpatient diabetes education program as a group (Figure 1) improved dramatically after the program, and the improvement was maintained for 24 months. Some patients, however, failed to show improvement during the first 3 months after the education program. Our findings suggest that depressive feelings were associated with this absence of educational effect. It is not clear whether depression has a direct adverse effect on glycemic control and/or if it simply hampers effective learning. Regardless, this finding underscores the importance of screening and treating depression in diabetes patients. The subgroup of patients who did not benefit from hospitalization also included those with initial HbA_Ic values lower than 7.0%. This finding suggests floor effects and supports the findings of Rubin et al.²⁰ and O'Connor et al.,²² who reported that patients with worse baseline conditions responded better to education. The results of this study suggest that repeated education may eventually be effective for patients whose glycemic control is chronically poor and who do not have depression.

Nevertheless, the presence of many patients who did relapse within 2 years of completing the inpatient diabetes education program needs to be addressed. It is our opinion that an educational program cannot be considered truly effective unless it proves effective in preventing relapse. Since our findings underscore the role of social support in relapse prevention, the rate of nonrelapse may be enhanced by incorporating this factor into diabetes education programs. It is interesting to note that our findings suggest that providing effective social support does not necessarily mean preparing meals for the patient, as the relapse rate was higher for patients whose meals were prepared by their spouses than for those who cooked for themselves. The group whose meals were prepared by the spouse consisted mainly of men, and the independent meal preparers consisted mainly of women. These men may be highly dependent on their wives for their diet regimens and therefore may not pay enough attention to what they eat, whereas the female patients may be more aware of what constitutes an appropriate meal and more likely to utilize this knowledge. Future studies may be needed to investigate exactly what specific supports enable better diabetes management and in what way the social support factor can be incorporated into the education of diabetes patients.

A strength of this study is that use of the Kaplan-Meier method allowed us to derive results from follow-up data that were obtained in an ordinary outpatient setting and that reflected actual outcomes of diabetes patients who received the course of diabetes education (a 2-week intensive program) that is typical in general hospitals in Japan. This study, however, has weaknesses. There was a substantial attrition rate: 226 patients, or 42.2% of the subjects admitted during the study period, were eliminated from the analyses. Caution, therefore, should be used in interpreting and generalizing our conclusions. This study did not include a control group, so it is not known how much additional benefit diabetes patients receive from the inpatient education program, compared to regular outpatient visits and guidance. The outcome measure consisted only of the level of metabolic control, as measured by HbA_Ic values. Other clinical measures, such as weight and the status of major diabetic complications (e.g., retinopathy, neuropathy, nephropathy, cardiovascular and cerebral vascular diseases) could also be considered as gauges of improvement or deterioration. A measure of self-care behavior should be incorporated into future studies, given the importance of this variable in the long-term outcome of diabetes. Self-care measures could be used to examine how diabetes education affects the development and maintenance of behavioral patterns of diabetes patients. In addition, findings about the factors that influence the maintenance of effective self-care behavior could be incorporated into future diabetes education programs.

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