Available online on 15.07.2025 at http://jddtonline.info

Journal of Drug Delivery and Therapeutics

Open Access to Pharmaceutical and Medical Research

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Open Access Full Text Article   Research Article

The Impact of Health-Related Quality of Life and Comorbidities in Chronic Kidney Disease: A Hospital-Based Cross-Sectional Study

Blessy Biju ¹*, Adlin D’cruz ¹, Sneha Jiby ¹, Melvin Devassy ¹, Rosmin Jacob ²

¹ Pharm D, St James College of Pharmaceutical Sciences, Chalakudy, Kerala.

² Assistant Professor, Department of Pharmacy Practice, St James College of Pharmaceutical Sciences, Chalakudy, Kerala.

^1,2 St James College of Pharmaceutical Sciences (NAAC Accredited), St James Hospital Trust Pharmaceutical Research Centre (DSIR Recognized) Chalakudy, Kerala.

 

 

INTRODUCTION

Chronic kidney disease (CKD) is a major contributor to global morbidity and mortality¹, ranked as the 8th leading cause of death in India by the Global Burden of Disease Study 2015².CKD is defined by either kidney damage or an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m², lasting for three months or longer, regardless of the underlying cause³. In India, CKD affects 17.2% of the population, with 6% having stage 3 or worse. Rising cases are linked to diabetes, hypertension, and heart disease⁴. Quality of life (QoL) is a key concern in chronic kidney disease (CKD), particularly in end-stage renal disease (ESRD), as it closely relates to mortality risk. Factors such as symptoms, medication side effects, and family dynamics contribute to reduced QoL, which worsens with declining kidney function⁵.  ESRD patients, especially those on hemodialysis, report lower health-related QoL than the general population, while those receiving transplants or peritoneal dialysis often fare better⁶. CKD also raises the risk of cardiovascular disease, early death, and higher healthcare use, further diminishing QoL⁷. Notably, cardiovascular mortality in CKD patients is 8–10 times higher than in those without CKD⁸.

The current study aims to assess the health-related quality of life (HRQoL) among CKD patients from stages 3 to 5, including hemodialysis patients, while also exploring the impact of multimorbidity on CKD.

MATERIALS AND METHODS

Study design and setting

A hospital-based cross-sectional study was conducted from November 2023 to April 2024, spanning a period of 6 months, among patients with chronic kidney disease in a tertiary care hospital.

 

Inclusion and exclusion criteria

The study enrolled 196 patients diagnosed with chronic kidney disease at a tertiary care hospital, meeting specific inclusion criteria. The inclusion criteria consisted of patients with chronic kidney disease attending nephrology, general medicine, and cardiology departments, adults aged 18 years or older, and those who signed a written informed consent. Exclusion criteria included patients who were under the age of 18, those unwilling to participate in the study, Patients with severe dementia, pregnant women, critically ill patients, and patients with incomplete medical records.

Ethical clearance

The study was approved by the Institutional Ethics Committee (IEC) with Approval No. SJPCEC/P25/PP/2023/006 of the St James’ College of Pharmaceutical Sciences, Chalakudy, Kerala, India.

Study procedure 

A total of 196 patients diagnosed with chronic kidney disease (CKD) stages 3 to 5D were assessed for health-related quality of life (HRQoL) utilizing the Kidney Disease Quality of Life Short Form Version 1.3 (KDQOL-SF 1.3) questionnaire, which has been validated in Malayalam⁹.  Informed consent was obtained from each participant, and the study protocol received approval from the institution's ethics committee. At the outset, sociodemographic information and biochemical parameters were collected. The glomerular filtration rate (GFR) was calculated using the CKD-EPI equation¹⁰, and patients were classified into three categories based on their CKD stages: stage 3, stage 4, and stage 5. The KDQOL-SF 1.3 questionnaire was employed to evaluate the HRQoL of these individuals¹¹. Those in the inpatient department (IPD) were requested to complete the questionnaire. For patients unable to fill out the KDQOL-SF 1.3 independently, their responses were recorded by the research investigator through direct interaction to ensure precise data collection.

To evaluate the influence of comorbidities on patients with chronic kidney disease (CKD), a thorough assessment was performed, which included reviews of medical history, clinical evaluations, and blood and urine analyses. This study concentrated on 12 specific comorbidities frequently observed in CKD patients: Hypertension, Diabetes Mellitus, Hyperlipidemia, Congestive Heart Failure, Coronary Artery Disease, Cerebrovascular Disease, Pyelonephritis, Glomerulonephritis, Polycystic Kidney Disease, Pulmonary Edema, Musculoskeletal Disorders, Urosepsis, Peripheral Vascular Disease, and Depression. These comorbidities were chosen due to their high occurrence among CKD patients and their clear identification through patient self-reports, documented medication histories, or specific laboratory results. The presence of each comorbidity was established based on the patient's self-reported history of doctor-diagnosed conditions, current use of disease-specific medications, or abnormal laboratory findings.

 

Statistical analysis

Continuous variables were presented as mean ± standard deviation (SD), and categorical variables were expressed as frequencies and percentages. Analysis of variance (ANOVA) was used to compare means across CKD stages for continuous variables, while chi-square tests assessed associations between categorical variables. Pearson’s correlation coefficients were calculated to examine the relationships between various biochemical parameters and HRQOL scores. Univariate and multivariable logistic regression analysis was conducted to identify independent variables associated with the number of comorbidities and p-value < 0.05 was considered statistically significant.

RESULTS 

Demographic and clinical characteristics of the patients 

In the study sample, the majority of participants were aged 61–80 years (58%), male (63%), and married (84%), with 43% having proteinuria and 31% having hyperuricemia. Notably, 77% were smokers and 45% reported a family history of kidney disease (table 1).

Table 1: Demographic and clinical characteristics of the patients 

Characteristics	Number (%)
Age (year) 20-40 41-60 61-80 81-100	8(4) 49(25) 114(58) 25(13)
Sex Female  Male	72(37) 124(63)
Marital status Married  Unmarried	165(84) 31(16)
Educational status No education Elementary  Secondary College and above	19(10) 42(21) 72(37) 63(32)
Proteinuria  Yes No	84(43) 112(57)
Hyperuricemia  Yes No	60(31) 136(69)
Smoking  Yes  No	151(77) 45(23)
Family history of kidney disease Yes No	88(45) 108(55)

 

Distribution of baseline biochemical parameters based on CKD stages

Significant biochemical differences were observed across CKD stages III to V. Hemoglobin levels, albumin, and GFR decreased progressively with advancing stages, while serum creatinine, potassium, serum urea, and uric acid levels increased significantly (p < 0.05). Serum creatinine and GFR showed the most marked changes (p < 0.001), reflecting worsening kidney function. However, age, sodium, and total protein levels did not differ significantly between the stages (p > 0.05) (table 2).

 

 

Table 2; Distribution of baseline biochemical parameters based on CKD stages

*significant at 0.05 level, ***significant at 0.001 level

 

 

Evaluation of HRQOL in patients with CKD 

Significant declines were observed in multiple KDQOL domains as CKD progressed from stage III to V. Physical functioning, role-physical, and pain scores showed marked reductions (p < 0.05), indicating impaired physical health in advanced stages. Mental domains such as emotional well-being, role-emotional, and social function also declined significantly (p < 0.001). Kidney disease-specific domains—including burden, symptoms, effects, sleep, and work status—worsened progressively across stages (p < 0.05). Patient satisfaction and dialysis staff encouragement were notably high in stage V, reflecting increased support and satisfaction at more advanced stages (table 3).

 

 

Table 3: Evaluation of HRQOL in patients with CKD 

*significant at 0.05 level , **significant at 0.01 level, ***significant at 0.001 level

 

Range, mean, and standard deviation of PCS, MCS, and KDCS scores

The physical composite summary score declined from CKD stage III (mean = 40.89) to stage IV (mean = 37.26), with a slight improvement in stage V (mean = 38.28), though overall scores remained low across all stages. Mental composite scores remained relatively stable in stages III and IV (mean = 39.81), but declined in stage V (mean = 38.38), indicating worsening mental health with disease progression. The kidney disease composite summary in stage V patients (mean = 43.00) reflected a moderate burden, suggesting considerable impact on disease-specific quality of life in advanced CKD (table 4).

 

 

Table 4; Range, mean, and standard deviation of PCS, MCS, and KDCS scores

CKD stages	Range	Mean	SD
Physical composite summary n=196
Stage III	8.80-63.80	40.89	12.62
Stage IV	8.80-63.80	37.26	11.63
Stage V	8.80-65.0	38.28	11.21
Total	8.80-65.0	38.85	11.88
Mental composite summary n=196
Stage III	12.38-65.0	39.81	11.71
Stage IV	12.38-58.92	39.81	11.30
Stage V	12.38-59.63	38.38	9.96
Total	12.38-65.0	39.32	10.97
Kidney disease composite summary N=67
Stage V	20.87-62.39	43.00	7.03

 

Correlation between PCS, MCS, and KDCS with various covariates

Hemoglobin levels showed a significant positive correlation with physical (r = 0.203), mental (r = 0.303), and kidney disease composite scores (r = 0.410), indicating better quality of life with higher hemoglobin. Serum creatinine was negatively correlated with all three domains (p < 0.05), reflecting worsening quality of life with declining renal function. GFR was positively associated with all composite scores (p < 0.05), especially with physical and kidney-specific domains. Serum uric acid was positively correlated with physical and mental scores, while serum potassium correlated significantly with the kidney disease summary. (table 5) 

 

 

Table 5: Correlation between PCS, MCS, and KDCS with various covariates

Parameter	Correlation coefficient	p values	Correlation coefficient	p values	Correlation coefficient	p values
	Physical composite summary n=196		Mental composite summary n=196		Kidney disease composite summary N=67
Age (in years)	-0.078	0.276	-0.062	0.385	-0.042	0.733
Hb level (g/dL)	0.203	0.039*	0.303	0.031*	0.410	0.043*
S. Creatinine (mg/dL)	-0.401	0.011*	-0.402	0.022*	-0.221	0.012*
S. Sodium (mg/dL)	0.071	0.324	0.018	0.804	0.219	0.075
Total Protein (g/dL)	-0.048	0.502	-0.143	0.045	0.204	0.098
S. Potassium (mg/dL)	0.044	0.537	-0.036	0.614	0.302	0.013*
S. Albumin (g/dL)	-0.021	0.765	-0.109	0.129	0.235	0.055
S. Uric acid(mg/dL)	0.169	0.018*	0.221	0.002**	-0.080	0.522
S. Urea (mg/dL)	-0.058	0.420	0.045	0.532	-0.353	0.003**
GFR (mL/min/1.73m2)	0.307	0.028*	0.244	0.029*	0.303	0.041*

* Correlation is significant at the 0.05 level, ** Correlation is significant at the 0.01 level (2-tailed)

 

Distribution based on complications of CKD

Among chronic kidney disease patients, hypertension emerged as the most prevalent complication, affecting 92.3% of the population. Cardiovascular disease and anemia follow, with prevalence rates of 50.5% and 46.4%, respectively. Hyperkalemia affects 41.3%, and metabolic acidosis 38.8% (table 6). 

 

Table 6; Distribution based on complications of CKD

COMPLICATIONS	NUMBER	PERCENTAGE (%)
Hypertension	181	92.3
Cardiovascular disease	99	50.5
Anemia	91	46.4
Hyperkalemia	81	41.3
Metabolic acidosis	76	38.8
Volume overload	59	30.1
Mineral bone disorder	56	28.6
Others (infection, pruritus, insomnia)	38	19.4

 

 

Prevalence of comorbidities among different stages of CKD 

Hypertension (92.3%) and diabetes mellitus (75.5%) were the most prevalent comorbidities among CKD patients, with their frequency increasing from stage III to V. Hyperlipidemia (30.6%) and coronary artery disease (41.8%) were also common, particularly in advanced stages. Conditions such as pulmonary edema, peripheral vascular disease, and depression showed a rising trend in later stages of CKD, reflecting a greater burden of systemic complications as kidney function declines. Other comorbidities like congestive heart failure, pyelonephritis, and glomerulonephritis were present in varying proportions but did not show a consistent pattern across stages (Table 7).

 

Table 7: Prevalence of comorbidities among different stages of CKD 

 

 

Number of comorbidities among different stages of CKD

The number of comorbidities increased with the progression of CKD. While most stage III and IV patients had 2–4 comorbidities, a significant proportion of stage V patients (55%) had five or more. Overall, 70 out of 196 patients (35.7%) had ≥5 comorbidities, highlighting the increasing multimorbidity burden in advanced CKD stages (table 8).

 

 

Table 8; Number of comorbidities among different stages of CKD

No of Comorbidities	CKD stage III (N=67)	CKD stage IV (N=62)	CKD stage V (N=67)	Total (n=196)
1	8	1	0	9
2	12	10	9	32
3	9	20	10	39
4	20	16	11	47
≥5	18	15	37	70

 

 

 

Independent variables associated with the number of comorbidities

Multivariate analysis revealed that age >55 years (AOR = 2.12; p < 0.001), lower eGFR (≤25 mL/min/1.73 m²; AOR = 1.46; p = 0.022), and presence of proteinuria (AOR = 1.39; p = 0.013) were independent predictors of having three or more comorbidities. Although smoking and hyperuricemia were significant in univariate analysis, they did not remain significant after adjustment. Sex and education level were not significantly associated with multimorbidity (Table 9).

 

 

 

 

Table 9: Independent variables associated with the number of comorbidities

Variable	Two or fewer comorbidities (vs. three or above)
	Univariate		Multivariatea
	COR (95% CI)	p-Value	AOR (95% CI)	p-Value
Age (≤ 55 vs >55)	3.13 (1.40-7.03)	0.004**	2.12 (1.22-4.28)	<0.001**
Sex (female vs male)	1.13 (0.56-2.30)	0.732	0.98 (0.44-2.20)	0.960
Education (up to secondary level vs above secondary)	0.68 (0.33-1.39)	0.289	0.92 (0.41-2.08)	0.927
Smoking (no vs yes)	0.63 (0.32-0.95)	0.039*	0.52 (0.14-1.12)	0.146
eGFR (≤25 vs >25 mL/min per 1.73 m2 )	0.61 (0.30-0.96)	0.032*	1.46 (1.01-1.97)	0.022*
Proteinuria (no vs yes)	2.35 (1.68-3.70)	0.036*	1.39 (1.02-2.09)	0.013*
Hyperuricemia (no vs yes)	2.48 (1.67-3.25)	0.021*	2.31 (0.87-4.47)	0.241

^a Adjusted for old age, sex, education, smoking, estimated glomerular filtration rate (eGFR), proteinuria, and hyperuricemia; OR, odds ratio; CI, confidence interval.

*significant at 0.05 level , **significant at 0.01 level

 

 

DISCUSSION 

Chronic kidney disease (CKD) is associated with increased hospitalisation, mortality, and reduced health-related quality of life (HRQOL), especially in patients on dialysis. While transplantation offers symptom relief and improved HRQOL, it remains lower than in those without CKD¹². In the present study, most patients were aged 61–80 years (58%) and predominantly male (63%). Although global data show CKD prevalence is slightly higher in women (14.6%) than men (12.8%), and more common in those over 65 (up to 44%), age-related kidney changes may explain the high prevalence in the elderly¹³.

The present study revealed that QoL decreased across all CKD stages, similar to previous studies^5,14.  The study findings align with previous studies showing poorer physical QoL compared to mental QoL in renal patients,^15,16, likely due to the chronic nature of CKD and patients' psychological adaptation over time. An intervention study in hemodialysis patients reported that Physical QOL was more affected initially but improved significantly after the intervention compared to mental QOL. Education and exercise proved effective in enhancing physical function, reducing pain, and improving daily tasks, making them ideal for addressing physical challenges¹⁷. Low income and hemoglobin levels are linked to poorer QoL¹⁵. CKD patients, particularly older dialysis patients, face a higher risk of cognitive decline, affecting memory, adherence, and quality of life, often linked to frailty, depression, and hospitalizations. Managing cardiovascular risks, reducing albuminuria, and promoting mental stimulation, exercise, and social support may help limit cognitive deterioration¹⁸. Hemodialysis patients report significantly lower QOL compared to the general population¹⁵. Studies in Kerala and Chennai revealed that self-management and social support moderately improve QOL in CKD patients, while HRQoL is impaired by financial hardships in hemodialysis. Decentralized, community-based care can address treatment challenges and productivity loss^19,20. Technology-based tools, such as apps, websites, virtual reality, and phone support, further improve psychological well-being, motivation, and treatment adherence²¹.

Chronic kidney disease (CKD) is associated with serious complications, including cardiovascular disease, hypertension, diabetes, anemia, hyperlipidemia, and metabolic bone disorders, significantly impacting morbidity, mortality, and quality of life^22,23. In our study, hypertension and diabetes are the most common comorbidities associated with CKD. Diabetes and hypertension are major causes of CKD and CVD, and managing modifiable risk factors can improve survival, reduce CVD, and slow CKD progression to ESRD²⁴. In our study, the burden of comorbidities increases with CKD progression, rising from fewer cases in stage III to a higher prevalence in stage IV, and peaking in stage V, where most patients have ≥5 comorbid conditions, in this the most prevalent one are hypertension (92.3) and diabetes (75.5). similar to the studies conducted by MacRae C et. al²⁴, Lau DCW et. al²⁵, and Li, Y. et, al²⁶, found that hypertension and diabetes is the most common comorbidity associated with CKD. A study conducted by Tonelli M et. al found that, Concordant comorbidities like diabetes, heart failure, and hypertension add to CKD's burden, with 25% of patients having three or more comorbidities and 7% having five or more²⁷. Hypertension is a hallmark of CKD, in CKD arises from sodium retention, renin-angiotensin-aldosterone activation, vascular stiffness, and endothelial dysfunction, leading to inflammation and oxidative stress. Obesity and Type 2 diabetes further exacerbate CKD progression through metabolic inflammation, pro-inflammatory cytokines, and gut microbiota changes. CKD-related dyslipidemia is marked by hypertriglyceridemia, altered LDL/HDL metabolism, and impaired reverse cholesterol transport, increasing cardiovascular risk²⁸. Managing diabetes and hypertension in CKD patients reduces healthcare resource utilization and costs, emphasizing the need for coordinated care focusing on glucose and blood pressure control²⁶.

CONCLUSION 

Chronic kidney disease (CKD) significantly impairs health-related quality of life, with the impact intensifying in advanced stages and in the presence of multiple comorbidities. The presence of multimorbidities, such as diabetes and hypertension, further exacerbated QoL decline, contributing to poorer clinical outcomes. 

Conflict of Interest: The authors declare no potential conflict of interest concerning the contents, authorship, and/or publication of this article.

Author Contributions: All authors have equal contributions in the preparation of the manuscript and compilation.

Source of Support: Nil

Funding: The authors declared that this study has received no financial support.

Informed Consent Statement: Informed consent was obtained from all subjects involved in the study. 

Data Availability Statement: The data presented in this study are available on request from the corresponding author. 

Ethical approval: The study was approved by the Institutional Ethics Committee (IEC) with Approval No. SJPCEC/P25/PP/2023/006 of the St James’ College of Pharmaceutical Sciences, Chalakudy, Kerala, India.

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