Introduction: Diabetes mellitus is a chronic disease affecting multiple organ systems leading to significant morbidity and mortality.

Objectives: To assess the impact of pharmacist led interventions in the quality of life in patients with type 2 diabetes mellitus.

Methods: A prospective, interventional study carried over a period of 12months from October 2014 – September 2015 in general medicine outpatient department of a tertiary care teaching hospital. A total of 106 Patients who fulfilled the study criteria were randomized into intervention group (55 patients) and usual care groups (51 patients) and completed the study. Patient information leaflet and medication counselling was provided to intervention group by the clinical pharmacist. Quality of life scores were collected by using Audit of diabetes dependent quality of life questionnaire to both the groups at the beginning and at the end of the study. In a group of 30 patients in the intervention group glycosylated haemoglobin was recorded at baseline and final follow up. These quality of life scores and glycaemic levels (fasting plasma glucose and post prandial plasma glucose) were obtained and compared between both groups at the end of the study.

Results: The intervention group showed an improvement in the quality of life score from -2.69±1.53 at the baseline to -1.92±0.59 at the final visit (p<0.05). The average HbA1c values decreased from 9.15±1.37 to 7.21±0.844 in the intervention group (p<0.05). There was a significant decrease in the post prandial blood glucose from 260.30±93.43 to 165.19±33.44 and fasting blood glucose from 163.45±56.03 to 114.45±18.87 from the baseline value to the final follow up in the intervention group (p<0.05).

Conclusion: The study shows that clinical pharmacist guided appropriate interventions were found to be effective in achieving better glycaemic control and better quality of life in patients with diabetes mellitus.

Keywords: diabetes mellitus, quality of life, pharmacist interventions, audit of diabetes dependent quality of life (ADDQoL)

Diabetes mellitus is a chronic disease that requires a continuous medical care along with patient education, self care, lifestyle modifications and support by the individual to prevent the risk of complications and associated co-morbidities. It has considerable impact on health status and quality of life and limit’s patient’s routine activities in terms of physical, social and psychological well-being.¹ The increase in number of people with diabetes mellitus is mainly because of population growth, aging, sedentary lifestyle, obesity and lack of physical activity.² Uncontrolled glucose levels result in the development of acute and chronic complications and are associated with disease progression, hospitalization, premature disability and mortality. Several observational studies have shown that intensive glycaemic control will lead to improved outcomes in cardiovascular, cerebrovascular and peripheral vascular diseases^3-5 The challenges in optimally managing the individuals with diabetes mellitus are aimed at preventing or reducing complications, improving life expectancy and quality of life. Quality of life represents the effects of an illness on a patient as perceived by the patient and yields complementary information to medical or epidemiological data. It can powerfully predict an individual’s capacity to manage his disease and maintain long term health and well being. Diabetes mellitus is associated with a major burden of physical and psychological disability and these are likely to substantially impair quality of life. Quality of life has been increasingly used as an important outcome measure to assess efficacy of diabetes care.⁶

 A multidisciplinary, collaborative and integrated team based approach with the involvement of all healthcare professionals along with the support of the individual with diabetes mellitus playing an active role in their care is needed in the management of diabetes mellitus. The role of pharmacist within the healthcare system has evolved from a product-centered approach to patient centered care and clinical activities7. Several randomised clinical trials have reported that clinical pharmacist interventions in diabetes mellitus care programmes through patient education and medication counseling improved glycaemic control, health related quality of life and other clinical outcomes in patients with diabetes mellitus.^8,9,10 However, most of the studies in the literature were carried out in countries such as United States, United Kingdom, Canada and Australia. Such service is deemed too have a greater effect in India than in the developed countries where the roles of pharmacist in patient care is not well established and prevalence of diabetes continue to rise rapidly. Therefore, the present study is aimed to assess the impact of pharmacist interventions in the quality of life in patients with type 2 diabetes mellitus.

It was a prospective, randomised interventional study conducted at a multi specialty tertiary care teaching hospital at Dakshina Kannada district, Mangalore, Karnataka. The study was carried out for a period of 12months (October 2014 to September 2015). Ethical committee clearance was obtained from the institutional ethical committee. The main outcome of this study was improvement in the quality of life assessed by using ADDQOL questionnaire in patients with diabetes mellitus and in their clinical parameters such as fasting blood sugar, post prandial blood sugar and glycosylated haemoglobin level. Patients with diabetes mellitus visiting the outpatient general medicine department were included in the study. Informed written consent was obtained from all participants in the study. Pregnant women, mentally challenged patients and critically ill patients were excluded from the study.

Patients who met the study criteria were randomly allocated to the intervention group or to the usual care group using simple randomization method. Patient details including demographic data, laboratory data and treatment details from patient case records were documented in the data collection form designed as per need of the study. Patients in the intervention group apart from the clinical care also received pharmaceutical care which included counseling on knowledge about the disease, signs and symptoms, instructions on dietary regulation, exercise and other life style modifications while the usual care group patients received clinical care only. The patient information leaflet including diabetic diet chart (prepared in three languages: English, Malayalam and Kannada in discussion with the chief dietician of the study hospital) were also provided to the intervention group in order to provide better counseling. The baseline score was obtained during the first visit for both intervention and usual care groups by using the ADDQOL questionnaire to access the quality of life of patients with diabetes mellitus before the pharmacist intervention. The pharmacist followed the patient’s progress with follow up visits and phone calls and the patient progress was recorded during each visits. On the first follow up visit, after two months from baseline, the intervention group was provided with patient information leaflet and medication counselling by the pharmacist. The medication counselling and education was continued during their second follow up, after four months from baseline. On the final interview, after eight months from baseline, both intervention and usual care groups were again provided the ADDQOL questionnaire and the final scores were collected and documented. The patient’s fasting and post prandial blood sugar levels of both intervention and usual care groups were recorded during the baseline and various follow ups of the study. Glycosylated haemoglobin (HbA1c), a measure of the average control of the blood glucose over the previous three months was also assessed in 30 patients from intervention group at baseline and final follow up. The data was analyzed by using SPSS software version 17.0. Descriptive statistics were used to describe demographic characteristics of the sample. Paired t-test was used for inter group analysis to compare follow up values with the baseline values and for categorical variables chi-square test was used. P-values of less than 0.05 were considered statistically significant.

Audit of Diabetes Dependent Quality of life questionnaire

Bradley’s questionnaire was used; Audit of Diabetes dependent Quality of Life (ADDQOL) was utilized to measure an individual perception of the impact of diabetes on their quality of life. The questionnaire was content and cultural validated and tested for reliability for the new language (cronbach’s alpha = 0.836) by using standard methods. Written permission was obtained from the developer of questionnaire (Dr. Claire Bradley) prior to the study. The questionnaire includes 19 life domain specific items and 2 overview items to be scored between -9 to +9, which is affected by diabetes. The ADDQOL allows the respond to indicate the aspects of life rate the amount of impact of diabetes and rate the perceived importance of each applicable aspect of life for the quality of life. The impact rating is multiplied by the importance rating for each applicable aspect of life to provide weighted impact scores, which can be averaged across all applicable domains to form a single, average weighted impact (AWI) score. The questionnaire took approximately 15-20 minutes to complete by each individual.

A total of 147 patients who met the study criteria were enrolled into the study. Out of them 106 patients completed the study (three follow ups of three month interval each) with 55 patients in the intervention group and 51 patients in the usual care group. Forty one patients had lost follow up due to unknown reasons. Among the 106 patients, 58 were males (49.07%) and 48 were females (50.92%). The age range of the participants was between 33 to 79 years in both the groups. The mean age of the study population in both intervention and usual care groups was found to be 58.38 ± 10.43 and 55.37 ± 9.88 (Mean ± SD) years respectively. The following Table 1 & 2 show the characteristics of the groups studied in relation to the sociodemographic variables. The results of the glycaemic control parameters which have been monitored at baseline and final visits shows that there is a wide variation between usual care and interventions group. In the case of intervention group, a statistically significant difference (p<0.005) was observed from the baseline to the final follow up in the fasting blood glucose from 163.45± 56.03 mg/dL to 114.45± 18.87mg/dL and for post prandial from 260.30± 93.43mg/dL to 165.19 ± 33.44mg/dL. The average fasting blood glucose for the usual care group at the baseline and the final follow up was found to be 146.48± 45.73 mg/dL and 162.52 ± 28.27 mg/dL and the average post prandial blood glucose for the usual care group at the baseline and final visits was found to be 264.88± 104.05 and 262.92 ± 57.31 respectively. Statistical tests revealed that these values were not statistically significant. The following Table 3 & 4 shows the comparison of both fasting and post prandial blood glycaemic levels among patient with diabetes mellitus between the groups (Figure 1 & 2).

Figure 1 Impact of diabetes on individual life domains in Intervention groups.

Glycosylated haemoglobin (HbA1c) values for 30 patients in the intervention group were recorded at the baseline and final follow up. Small number was taken due to financial constraints. A significant reduction in the HbA1c level in the intervention group was observed from the baseline value when compared to the final follow up. The comparison of HbA1c values from the baseline to final follow up in the intervention group is shown in the Table 5.

All the patients completed the ADDQoL questionnaire at their first visit with the pharmacist, before any educational activity (baseline) and at their final follow up visit. The average baseline score was found to be -2.98± 1.68 for the usual care group and -2.69±1.53 for the intervention group. In the final interview the usual care group score was found to be -3.62± 0.54 which was not statistically significant from the baseline scores (p>0.05). However, in the intervention group the score was found to be -1.92 ± 0.59 which was found to be statistically significant from the baseline values (p<0.001). The comparison of quality of life scores within groups at the baseline and final follow up is shown in the following Table 6.

Figure 2 Impact of diabetes on Quality of life.

Diabetes mellitus is a growing public health concern all over the world. It imposes a personal burden on individuals, negatively affects the health related quality of life and consumes a significant portion of society’s scare health care resources. This negative impact affects multiple aspects of a person’s life, including the social, psychological part of one’s life being chronically ill, dietary restrictions, symptoms of inadequate metabolic control, chronic complications and lifelong disabilities.¹¹ The present study evaluated the impact of pharmacist interventions on the quality of life in patients with type 2 diabetes mellitus showed that intervention group who received pharmacist interventions reported overall improvement in diabetes-specific health related quality of life using ADDQOL questionnaire (p<0.05). Pharmacist interventions are considered an important factor in improving glycaemic control and there by achieving better quality of life. Pharmacist’s interventions include a printed educational leaflet containing information about diabetes and medication counselling on drug, disease, diet, exercise, lifestyle modification and self-care management which will reinforce patients to achieve target goal. Evidence is clear that improving glycaemic control and preventing complications result in significant cost saving and improved quality of life.¹² From the study, it was found that all the domains mentioned in the questionnaire were affected by the patients with diabetes mellitus. The changes in the average scores of both the groups (intervention and usual care) were observed. In the intervention group the changes in the quality of life score was found to be more significant (p <0.005) as compared to the usual care group. In the study , it was found that the most commonly affected domains of quality of life questionnaire in the study participants were freedom to eat, freedom to drink, family life, self confidence, depend on others, physical appearance , finances, motivation, social life and personal relationship domain of the patients. The improvement in the ADDQoL may in part be attributed to the increased contact of patients with diabetes mellitus with the clinical pharmacist, but it is also likely to be associated with improved adherence to life style modification and self care activities. This study results was consistent with the study carried out by various authors who showed that better glycaemic control in patient with diabetes mellitus is associated with few physical symptoms, better mood and well being which ultimately impacts better quality of life and may helps in health expenditure.^13-17

Blood glucose levels

Statistically significant differences in blood glucose levels were observed in the intervention group during their first follow up after intervention and sustained until the end of the study period. The blood glucose levels (both fasting blood glucose and post prandial levels) showed a statistically significant reduction from baseline visit until the final follow up of the study period for the intervention group as compared to the usual care group. Table 4 & 5 shows the comparison of both fasting and post prandial blood glycaemic levels amongst patient with diabetes mellitus between the groups. Glycosylated haemoglobin (HbA1c) is the internationally accepted test for glycaemic control. Small number was taken due to financial constraints. A significant reduction in the HbA1c level in the intervention group was observed from the baseline value when compared to the final follow up. The comparison of HbA1c values from the baseline to final follow up in the intervention group is shown in the Table 6.

The results emphasizes the positive impact of clinical pharmacist mediated interventions on drug, disease, diet, exercise, life style modifications and self care practices in achieving better management of diabetes with significant reduction in glycaemic levels and improved quality of life in patients with type 2 diabetes mellitus. The improved quality of life scores in various domains clearly indicates the benefits of integrating clinical pharmacist services in a multidisciplinary team for a comprehensive management of diabetes mellitus in a hospital care settings.

Authors are thankful to Principal Dr CS Shastry, NGSM Institute of Pharmaceutical Sciences for providing necessary support to the study. Secondly, we would like to thank Department of General Medicine, Justice KS Hegde charitable Hospital, Mangalore for permitting to conduct the study in the hospital. We express special thanks to Dr. Karuna Ramesh Kumar, Medical Superintendent for providing us special concession for carrying out glycosylated haemoglobin in selected patients of our study. Authors would like to express their great appreciations to Professor Claire Bradley, (Department of Psychology at the Royal Hallow University of London in the UK) for giving us permission to use the ADDQOL (Audit of Diabetes Dependent Quality of Life) questionnaire.

Author declares that there is no conflict of interest.

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