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Saudi Journal of Kidney Diseases and Transplantation
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ORIGINAL ARTICLE  
Year : 2017  |  Volume : 28  |  Issue : 6  |  Page : 1293-1306
Impact of pharmaceutical care on the health-related quality of life among hemodialysis patients – A multicenter randomized controlled study


1 Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal; Department of Pharmacy Practice, Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences, Nitte University, Deralakatte, Mangaluru, India
2 Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India
3 Department of Nephrology, Kasturba Medical College, Kasturba Hospital, Manipal University, Manipal, Karnataka, India

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Date of Web Publication18-Dec-2017
 

   Abstract 


The present study was planned to assess the impact of pharmaceutical care on the health-related quality of life (HRQoL) among hemodialysis (HD) patients. An open-label, randomized control study was carried out at three different HD centers of teaching, government, and corporate hospitals in South India. The patients were randomized into two groups (Usual Care Group [UC] and Pharmaceutical Care Group [PC]) by block design method. The PC group received the normal care along with pharmaceutical care delivered by a qualified registered pharmacist. The assessment of the HRQoL was carried out at baseline, 6th and 12th months for the both groups for a total of 12-month follow-up. A total number of 200 patients were recruited from the three HD centers. At the end of the study, 153 patients were followed. Out of 153 patients, 83 were from academic hospital (UC, n =41; PC, n = 42), 18 from government hospital (UC, n = 09; PC, n = 09), and 52 from corporate hospital (UC, n = 25; PC, n = 27). The HRQoL scores were significantly improved over time in the domains noticed with regard to the “physical functioning, general health, emotional well-being, social functioning, symptom/problem list, and effects of kidney disease” in all the three centers of PC group compared to UC group with P <0.05. The pharmaceutical care provided by a trained pharmacist had positive impact in HRQoL of HD patients.

How to cite this article:
Mateti UV, Nagappa AN, Attur RP, Nagarapu SP, Rangaswamy D. Impact of pharmaceutical care on the health-related quality of life among hemodialysis patients – A multicenter randomized controlled study. Saudi J Kidney Dis Transpl 2017;28:1293-306

How to cite this URL:
Mateti UV, Nagappa AN, Attur RP, Nagarapu SP, Rangaswamy D. Impact of pharmaceutical care on the health-related quality of life among hemodialysis patients – A multicenter randomized controlled study. Saudi J Kidney Dis Transpl [serial online] 2017 [cited 2019 Dec 7];28:1293-306. Available from: http://www.sjkdt.org/text.asp?2017/28/6/1293/220879



   Introduction Top


End-stage renal disease (ESRD) refers to the stage-5 chronic kidney disease (CKD) when kidneys no longer function at a level needed for survival. This stage is reached when overall renal function, measured by glomerular filtration rate, is <15 mL/min of normal.[1] It has been reported that globally ESRD is the 12th highest cause of disease associated mortality and annually there are 830,000 deaths.[2] In India, it is a “hidden epidemic” because there is no nation-wide ESRD registry. Some epidemiological studies have revealed that millions of people suffer from CKD.[3]

As such, ESRD is increasing in epidemic proportions in India and will be the third biggest culprit of morbidity and mortality after cancer and cardiovascular diseases. The more frequent complications of hemodialysis (HD) includes hypotension (20%–30%), cramps (5%–20%), nausea and vomiting (5%–15%), head-ache (5%), chest pain (2%–5%), back pain (2%–5%), itching (5%), and fever and chills (<1%).[4] The comorbidities such as cardiovascular diseases, hypertension, diabetes, renal anemia, hyperphosphatemia, congestive heart failure, peripheral vascular disease, and malnutrition can cause severe consequences to the HD patients.[5],[6] The review of literature suggests that the quality of life (QoL) is compromised in HD patients compared to general population.[7]

The WHO defines the health as “a state of complete physical, mental, and social well-being not merely the absence of disease”. The WHO also defines QoL as “individuals” perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.”[8]

Numerous publications have focused on drug-related problems (DRPs) which are very common in patients on dialysis with estimation of one DRP for every 15 medicine exposures[9] due to DRPs-induced morbidity and nonadherence to the medications with a high rate of 67%.[10] Most of the publications have revealed that there is a lack of knowledge, attitude, and practice (KAP) regarding the drugs, disease, and lifestyle changes among CKD patients on HD.[11],[12] Poor adherence is a common problem where patient's myths and beliefs play an important role in shaping the KAP. Health-related QoL (HRQoL) is an important measure in ESRD because long-term HD often compromises the patient's ability to earn affecting financial income. As a result, the patients invariably depend on family income, and this has a negative impact on the marital status, family, and social activities. The QoL of HD patients is found to be deteriorated compared to general population and other chronic diseases.[11],[13] There is a need to take stock of situation regarding QoL and the components of social, pathological, and ESRD-related morbidities. The outcome of the inventory of above would be able to identify the key factors and plan for diminishing their effects on QoL of patients.

Health education is needed for patients to assist them in self-care. In addition to selfcare, motivation plays an important role among dialysis patients. Patients need updates on issues of drugs, disease, and lifestyle changes appropriate for the failed renal function.[5] This study was aimed to assess the impact of Pharmaceutical Care on the HRQoL among HD patients of teaching, government, and corporate hospitals.


   Patients and Methods Top


Study design and period

This was an open-label, randomized control trial Registered under the Clinical Trial Registry of India (Ref. no. CTRI/2014/004900) was carried out for 15 months between March 2014–May 2015 at three different HD centers of teaching, government, and corporate hospitals.

Sample size

The sample size was calculated based on the primary objective and the change in QoL scores at 0, 6, and 12 months repeated measure at 84% power and 5% level of significance. The minimum sample required for the study is 76 patients per group and anticipating a dropout rate of 20%, the required sample size is 76/0.8 = 95 per each group.

Ethical approval

This study was approved by the Institutional Ethics Committee (Ref. no. IEC/165/2013), before the initiation.

Study criteria

The inclusion criteria for choosing the patients was based on HD-continuously for preceding three months, two sessions of HDs per week, and patients in the age group of 18–75 years who can speak at least English or Kannada language and who gave written informed consent. The patients who were not willing to participate or had psychiatric illness or shifted from peritoneal dialysis or kidney transplantation to HD were excluded from the study.

Randomization, sequence generation, and sampling method

The patients were randomized into two groups [Usual Care Group (UC) and Pharmaceutical Care Group (PC)] by block design method with the block size of 6 at academic, 4 at the government and corporate hospitals and concealed in opaque sealed covers. Randomization sequence was generated based on the weekly visits of HD patients to the centers by the statistic department and concealed in the opaque sealed covers. For each center, there was one UC and PC group in the study. The patients were recruited proportionally from the each center in 1:1 ratio of UC and PC group in the study by the purposive sampling method.

Usual care group

This group received the usual care by the hospital staff such as physicians, nurses, and technicians.

Pharmaceutical care group

The PC group received the usual care along with pharmaceutical care delivered by a qualified registered pharmacist. The customized care plan was designed and delivered to the patients on monthly basis based on the condition and need of the patient by the WHO-FIP Pharmaceutical care model.[14] The plan was updated based on monthly observations of patients in the area of diet, drugs, and lifestyle. The PC emphasized motivation and patient education with validated protocols regarding knowledge about disease, medication, lifestyle changes, nutritional information, personal interview, and medication review. The nutritional advice for HD and comorbidities, education on foodstuffs containing potassium, phosphate, protein, sodium, depending on the patients' prerequisite, and fluid constraints. The PC group was provided with a validated pictogrambased on patient information leaflets and advice on medication administration, laboratory monitoring and adherence to HD and medication issues.

Data collection

Data were collected in predesigned forms which had sociodemographic details such as age, gender, educational status, economic status, HD vintage, and comorbidities. Socioeconomic status of the patients was calculated using Kuppuswamy socioeconomic scale.[15] Kuppuswamy scale is a measure of patients' socio-economic status, which has a blend of social and economic variables. It classifies the patients into low-, middle-, and high-socioeconomic status.[15] Other details such as etiology, distance traveled to the HD center and number of hours of HD per week were recorded. The detailed patients recruitment and follow-up during the study are presented in the flowchart [Figure 1] [Figure 2] [Figure 3].
Figure 1: Consort flowchart for academic hospital hemodialysis patients.

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Figure 2: Consort flowchart for government hospital hemodialysis patients.

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Figure 3: Consort flowchart for corporate hospital hemodialysis patients.

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Health-related quality of life assessment

The QoL was assessed using validated KDQoL-36 instrument, which is a generic and disease-specific instrument consisting of 12 generic questions and 24 disease-specific questions KDQoL-36 was self-administered at baseline, 6th and 12th months to assess the HRQoL scores.


   Statistical Analysis Top


Data were analyzed based on per-protocol method. Repeated measures of ANOVA analysis was performed for the analysis of change in the HRQoL scores in the two groups. The P <0.05 was considered as statistically significant.


   Results Top


A total number of 200 patients were recruited from the three HD centers. Out of 200 patients, 104 from academic hospital (UC, n = 52; PC, n = 52), 26 government hospital (UC, n = 13; PC, n = 13), and 70 corporate hospital (UC, n = 35; PC, n = 35). At the end of the study, 153 patients were followed. Out of 153 patients, 83 were from academic hospital (UC, n = 41; PC, n = 42), 18 from government hospital (UC, n = 09; PC, n =09), and 52 from corporate hospital (UC, n =25; PC, n = 27). There were 47 dropouts in total, out of which 25 were in UC group and 22 in PC group.

Baseline characteristics of hemodialysis patients

The mean age of HD patients from the academic hospital (UC group is 49.40 years; PC group is 52.78 years), government hospital (UC group is 48 years; PC group is 49.15 years), and corporate hospital (UC group is 53.77 years; PC group is 52.97 years); gender-wise distribution of men from the academic hospital (UC group is 76.9%; PC group is 82.7%), government hospital (UC group is 76.9%; PC group is 84.6%), and corporate hospital (UC group is 74.3%; PC group is 68.6%), majority of the HD patients were from the lower middle class, rural background who were not doing any job. The median vintage of HD was (UC group is 50; PC group is 53), (UC group is 26; PC group is 24), and (UC group is 32; PC group is 36) months in academic, government, and corporate hospital patients, respectively. The baseline demographics such as age, gender, education, marital status, working status, domiciliary status, socioeconomic status, income per month, health-care schemes, distance traveled to the HD centers, HD vintage, number of hours of HD per week, risk factors, and comorbidities were not significantly different in the UC group vs. PC group in all the three HD centers. The detailed baseline characteristics of HD patients are presented in [Table 1]. The baseline HRQoL score of KDQoL-36 domains such as short form-12 (SF-12) components and ESRD-targeted areas were not significantly different in the UC group vs. PC group in all the three HD centers. The detailed baseline HRQoL scores of the HD patients are presented in [Table 2].
Table 1: Baseline demographic details of HD patients from academic, government and corporate hospitals.

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Table 2: HRQOL baseline scores of HD patients from academic, government, and corporate hospitals.

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Humanistic outcomes

The PC group had significantly improved its HRQoL scores comparatively to HRQoL scores of UC group at different time intervals when analyzed by repeated measures of ANOVA. The increase in HRQoL score domains noticed with regard to the “physical functioning, general health, emotional well-being, social functioning, symptom/problem list, and effects of kidney disease” in PC group compared to UC group with a statistically significance of P <0.05. The changes in HRQoL domains scores across the study period of the HD patients are presented in the [Table 3] [Table 2] [Table 3] [Table 4] [Table 5] for academic hospital, government hospital, and corporate hospital.
Table 3: HRQOL scores for UC and PC groups of academic hospital HD patients.

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Table 4: HRQOL scores for UC and PC groups of Government Hospital HD patients.

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Table 5: HRQOL Scores for UC and PC groups of Corporate Hospital HD patients.

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   Discussion Top


In the present study, HRQoL was assessed by utilizing the generic and disease-specific validated KDQoL-36 instrument in contrast to the previously conducted studies in the HRQoL of HD patients was measured using the genericspecific HRQoL instruments such as SF-36, Karnofsky Performance Status, EQ-5D, and WHO-Bref.[16],[17],[18],[19],[20] The study carried out by Apostolou et al, results suggest that the disease-specific HRQoL instruments were better compared with the generic instruments in identifying specific items that affected the overall QoL in dialysis patients.[21] The previously conducted HRQoL studies on HD patients revealed that the HRQoL is compromised in HD patients.[7],[20],[22]

The pharmaceutical care is a comprehensive patient education system serving in the areas of drug, disease, nutritional, and lifestyle information with an objective to empower the patient with self-management of his or her condition. Pharmaceutical care also focuses on motivating the patients to take the ownership of their disease management with a limitation for day-to-day management. However, they have sought a professional guidance whenever the self-management fails to deliver satisfactory QoL. The patients were specifically trained to identify many early symptoms of the prognosis of morbidity and are instructed to revert back to the health-care professionals as early as possible with an aim to avoid and mitigate any serious complications arising due to unmanaged morbid conditions.

In the present study, the intervention of pharmaceutical care showed significant improvement in HRQoL scores over time in the domains of “physical functioning, general health, emotional well-being, social functioning, symptom/problem list, and effects of kidney disease” in all the three centers of PC group compared to UC group. These results were comparable with the studies conducted in the intervention of patient counseling, patient education, and pharmaceutical care in the HRQoL of HD patients.[9],[11],[16],[17],[18],[19],[20],[23],[24] The study carried out by Abraham et al, assessed the impact of patient counseling in HRQoL of HD patients at 6 and 12 months in India. The increase in HRQoL scores was observed in “physical, psychological, environmental, and social domains” in the test group compared to control group.[16],[17],[18] The study carried out by Thomas et al assessed the impact of patient counseling in HRQoL of HD patients at 6 months in India. The increase in HRQoL scores by 2% in the test group were observed as compared to control group.[16]

The study carried out by Baraz et al, assessed the post-interventional educational program in HRQoL of HD patients in Iran. The increase in HRQoL domains scores was observed in “physical functioning, role physical, social functioning, and mental health” after the educational intervention.[24] The study carried out by Dashti-Khavidaki et al, assessed the impact of pharmaceutical care in HRQoL of HD patients at six months in Iran. The increase in HRQoL domains scores was observed in “role-emotional, mental health, social functioning, and general health dimensions” in case group as compared to control group.[25] In a study carried out in the USA on the intervention of pharmaceutical care in HRQoL of HD patients. The increase in HRQoL domains scores was observed in “eating/drinking, physical activities, leisure time, psychosocial activities, and impact of treatment” over time in PC compared to standard care group.[23]

The study carried out by Aghakhani et al assessed the intervention of nutritional education in HRQoL of HD patients in Iran. The increase in HRQoL domains scores was observed in diet-counseled group compared to control group.[26] The registered pharmacist-delivered PC to HD patients in this study had an affirmative impact in HRQoL. It is indefinite not definite whether pharmacists with general backgrounds might impact on HRQoL to the same level.

This is the premier study in India carried out in the multi-health-care centers representing a spectrum of hospitals from the teaching, government, and private sectors with an objective to assess the differences in response to the intervention of pharmaceutical care in HRQoL. The “WHO-FIP pharmaceutical care” plan model delivered by the registered pharmacist regarding the knowledge about disease, medications, lifestyle changes, nutritional information, personal interview, and medication review had positive impact in the HRQoL. The intervention of pharmaceutical care significantly improved the HRQoL scores over time in the domains noticed with regard to the “physical functioning, general health, emotional well-being, social functioning, symptom/problem list, and effects of kidney disease” in all the three centers of PC group compared to UC group with P value <0.05. Sociodemographic characters and HRQoL do not differ among patient groups on HD from public funded, academic, and private funded/corporate settings. Pharmaceutical care provided by a trained pharmacist has potential in improving HRQoL.


   Acknowledgments Top


The authors would like to thank all the patients who have actively participated in the present study. Our deepest thanks go to Dr. Manohar Bairy, consultant nephrologist at the Tan Tock Seng Hospital, Singapore, for his valuable suggestions and we also place on record our gratitude to the hospitals of HD centers for giving permission to conduct this study. Finally, we owe our special thanks to Manipal University for providing us with the research facilities.

Conflict of interest: None declared.



 
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Correspondence Address:
Uday Venkat Mateti
Department of Pharmacy Practice, Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences, Nitte University, Mangaluru-575 018, Karnataka
India
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DOI: 10.4103/1319-2442.220879

PMID: 29265040

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