|Year : 2019 | Volume
| Issue : 2 | Page : 81-88
Evaluation of quality of life in type 2 diabetes mellitus patients using quality of life instrument for indian diabetic patients: A cross-sectional study
Reeni John, Sanjivani Pise, Leena Chaudhari, Prasanna R Deshpande
Department of Clinical Pharmacy, Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be University), Pune, Maharashtra, India
|Date of Web Publication||3-Jul-2019|
Dr. Prasanna R Deshpande
Department of Clinical Pharmacy, Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be University), Pune - 411 038, Maharashtra
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease with major impact on the quality of life (QoL) in terms of various domains such as social, physical, and mental well-being. Aim: This study aimed to study the factors determining the QoL in T2DM patients. Materials and Methods: A prospective, observational study was conducted in a tertiary care hospital for 6 months. Patients of age ≥18 years and diagnosed with T2DM for ≥6 months (with and without comorbidities) were enrolled for the study. The sociodemographic and clinical characteristics were noted in the self-designed pro forma. The QoL was assessed by the Marathi-translated version of QoL Instrument for Indian Diabetes Patients questionnaire of 34 items and 8 domains. The reliability was validated by Cronbach's alpha. The differences were analyzed by Mann–Whitney U-test and Kruskal–Walis test. Results: Out of 153 T2DM patients, majority were elderly males with mean age of 61.23 ± 11.4 years, married (83%), lower-middle income (57%), urban (51.6%), primary education (46.4%), had diabetes for 5 years or less (42.5%), had positive family history of diabetes (32.6%), and were treated by intensive therapy mainly insulin (41.2%). Statistically significant (P < 0.05) association was found between different domains of QoL and family history, hypertension, body mass index, educational status, marital status, income status, treatment, and complications. The domains of diet satisfaction and general health with the least mean estimates of 7.70 ± 2.62 and 8.25 ± 3.08, respectively, were predominantly affected. Conclusion: QoL is an important parameter in diabetes treatment modality. Different factors affected QoL in diabetics in our study. Further studies are definitely needed for better data generation at national level.
Keywords: Quality of Life Instrument for Indian Diabetes patients questionnaire, quality of life, type 2 diabetes mellitus
|How to cite this article:|
John R, Pise S, Chaudhari L, Deshpande PR. Evaluation of quality of life in type 2 diabetes mellitus patients using quality of life instrument for indian diabetic patients: A cross-sectional study. J Mid-life Health 2019;10:81-8
|How to cite this URL:|
John R, Pise S, Chaudhari L, Deshpande PR. Evaluation of quality of life in type 2 diabetes mellitus patients using quality of life instrument for indian diabetic patients: A cross-sectional study. J Mid-life Health [serial online] 2019 [cited 2019 Oct 17];10:81-8. Available from: http://www.jmidlifehealth.org/text.asp?2019/10/2/81/261979
| Introduction|| |
India is titled as the diabetes capital of the world, with an estimate of about 72.94 million diabetic patients in 2017. Every 5th diabetic in the world is an Indian and the rising trends are due to aging, obesity, physical inactivity, genetic predisposition, rural to urban migration, and family history.,, Every diabetic patient's life is unique and they feel psychologically overwhelmed by the numerous rules that the disease constrain them to follow. Therefore, assessing the quality of life (QoL) of patients is important due to the fact that each individual has their own individualized perception on their physical, emotional, and social well-being, which includes a cognitive element satisfaction as well as emotional component happiness. There are various factors associated with both short-term and long-term diabetes management that enumerate to the QoL negatively or positively. The microvascular and macrovascular complications and longer duration of illness associated with the disease are the foremost important factors that affects the patient's QoL. The anthropometric factors such as body mass index (BMI) and sociodemographic factors such as age, gender, marital status, income status and educational status adherence to proper glycemic management, and strictly advised diet and exercise routine may have significant positive or negative correlation. A declining QoL and depression can also strongly influence a patient's commitment toward controlling his disease. Most of the existing QoL questionnaires for diabetics have been developed in the Western population which are socially, culturally, and economically different from Indian participants. By considering all such aspects, we aimed to determine the QoL of Indian diabetics using QoL Instrument for Indian diabetes patients (QOLID).
| Materials and Methods|| |
Setting and participants
A prospective, observational study was conducted for 6 months. A total of 153 participants diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months previously and were ≥18 years of age whoever admitted into the hospital were enrolled into the study. Gestational diabetes patients, those with mental disability, and those not willing to cooperate were excluded from the study.
The study was approved by the Institutional Ethics Committee. Written informed consents were obtained from the study participants before the study.
Data collection procedure and instrument
Details regarding sociodemographics such as age, BMI, clinical profile, family history, and duration of diabetes were obtained from a self-predesigned patients' pro forma. QOLID, a tool developed for the Indian diabetes patients comprising a set of 34 items representing the 8 domains (namely, role limitation due to the physical health, physical endurance, general health, treatment satisfaction, symptom frequency, financial worries, mental health, and diet satisfaction) was used to assess the QoL. Initially, a pilot study was conducted by providing translated Marathi version validated linguistically by experts (n = 3) among 12 patients as per the inclusion criteria. The pilot results were excluded in final results. The Cronbach's alpha was obtained to determine the internal consistency of QOLID instrument.
Statistical and data analysis
The data were entered and analyzed in Microsoft Excel 2007. The margin of error of was determined by the Raosoft calculator for the sample size. The quantitative variables were expressed as mean ± standard deviation. The differences among groups were analyzed by Mann–Whitney U-test and Kruskal–Walis test (P < 0.5).,
| Results|| |
Sociodemographic and clinical characteristics of the study population
Out of the 153 T2DM patients, majority of the population were with mean age of 61.23 ± 11.41 years, 57.5% were elderly males, 17.6% were at an increased risk according to the Asian BMI cutoff, and 69.3% were predominantly on mixed diet. The majority of the respondents had only primary education (46.4%) or was illiterate (32.7%). Among the individuals, most of them were married (83%), 79% were from the urban areas, and 51.6% and 32% were from lower-middle or upper-middle income status families, respectively. The results obtained had a margin of error of 7.8% for the 153 patients, calculated by Raosoft calculator. The internal consistency for the instrument was found to be 0.73 (for 10 randomly selected patients).
The large population had diabetes for 5 years or less (42.5%) with 32.6% positive family history of diabetes. Of all patients, 6.5% were found to be smokers and tobacco chewers each and about 9.2% were alcohol consumers. Majority patients of the study population were treated by insulin (41.2%) or oral hypoglycemic agent (OHA) were combined (34.6%) to maintain their optimum glycemic level [Table 1].
|Table 1: Sociodemographic and clinical characteristics of the study population (n=153)|
Click here to view
[Table 2] summarizes that in most of the patients random blood sugar (RBS) level was obtained (268.21 ± 112.71), whereas in few patients, fasting blood sugar was also monitored (223.33 ± 96.63), and about 77 patients were determined with a mean hemoglobin A1c (HbA1c) (%) value of 9.16 ± 2.45. Furthermore, the study population had a mean systolic blood pressure of 139.12 ± 22.09 and diastolic blood pressure of 83.98 ± 11.4.
[Figure 1] lists the complications associated with T2DM patients. The most common macrovascular complication observed were cardiovascular complications (67.97%) and diabetic foot (4.57%) in microvascular-related complications.
Quality of life and its associated domains
[Table 3] indicates QoL based on 8 domains as represented. Overall mean score estimates of 4.4 and 4.12 determine higher QoL and minimal role limitation due to physical health and physical endurance, respectively. In domains of diet satisfaction, general health, and financial worries with lower mean estimates of 2.57, 2.75, and 2.83, respectively, predominantly affect the QoL of diabetic patients.
Differentials in quality of life
As shown in [Table 4]a, differences were observed between family history of diabetes and symptom botherness scores (P = 0.0001) and presence of hypertension and financial worries (P ≤ 0.0001). As shown in [Table 4]b, following statistically differences were observed:
- BMI versus financial worries (P = 0.0071) and diet satisfaction (P = 0.0157)
- Educational status versus treatment satisfaction (P = 0.0491), general health (P < 0.001), financial worries (P < 0.001), emotional health (P < 0.001), and overall QoL (P = 0.0004)
- Marital status versus general health (P = 0.0007) and emotional health (0.0119)
- Income status versus financial worries (P < 0.0001)
- Treatment versus financial worries (P = 0.0001), diet satisfaction (P = 0.0145), and overall QoL (P = 0.0192)
- Complications versus symptom botherness (P = 0.0069) and overall QoL (P < 0.001).
The mean scores and standard deviation with respect to each domain were as shown in [Table 5].
|Table 5: Mean of quality of life scores and standard deviation of independent variables in various domains|
Click here to view
| Discussion|| |
The QoL is gradually gaining importance with recent guidelines from the American Diabetes Association that emphasize on the need of “patient-centered” approach of the management of T2DM patients in terms of QoL, prevention of diabetic complications, and achievement of glycemic targets. However, there are very few articles available in respect to the Indian scenario. To the best of our knowledge, this is one of the rare studies conducted on Indian diabetics' QoL. Furthermore, to the best of our knowledge, this is the first study in which Marathi version of the QOLID instrument has been used.
Correlation of significant parameters with various domains
Family history and symptom botherness
We found a significant correlation observed in the domain of symptom botherness and family history (P < 0.005) which is similar finding to the study conducted by Saleh et al.; patients with positive family history had higher mean QoL scores compared to those with no family history.
Body mass index and financial worries and diet satisfaction
Our findings indicate that overweight patients (BMI = 23–27.5 kg/m2), and underweight patients (BMI ≤18.5 kg/m2) have lower mean QoL scores as compared to the normal patients. Patient's anthropometric measurement has significant correlation in the domains of financial worries and diet satisfaction (P < 0.005). There is increased risk of complications associated with increased BMI, which further causes the deterioration of physical well-being and thereby contribute to increased financial worries. Magnitudes in the correlation of BMI had negative impact on the T2DM patients QoL in many studies, and our study findings are consistent to other studies such as Akinci et al. and Redekop et al.
Education status and general health, treatment satisfaction, financial worries, and emotional health
The education status was the major sociodemographic variable associated with these 4 of the 8 QoL domains in our study. The mean scores of QoL is comparatively lower in the primary educated and illiterates as compared to the higher educated T2DM patients and significant variations due to education status is observed in the domains of general health, treatment satisfaction, financial worries, and emotional health (P < 0.005) which is consistent to the cross-sectional study conducted by Martinez et al., in which education level was associated with 5 of the 6 QoL domains. Nyanzi et al. study in Ugandan perspective also showed similar association of lower education level with detrimental QoL. Although there are contradictory results about this relationship, diabetic patients with higher education have positive self-esteem, better knowledge, and understanding of the disease, its treatment, and complications.
Marital status and general health and emotional health
In the present study, we observed that lower QoL was related to widowed or divorced patients than married people with higher QoL. There was a significant correlation of marital status in the domains of general health and emotional or mental health (P < 0.05) and our study findings were in parallel with studies conducted by Papazafiropoulou et al. and Yildiz et al.
Income status and financial worries
In this study, income also played a significant role in QoL which was in accordance to cross-sectional study conducted by Saleh et al. The association between quality of life and financial aspect have been studied in articles like Nagpal et al., Varghese et al., Papazafiropoulou et al., Yildiz et al., Shim et al., Didarloo et al., Praveen Kumar et al., Sandhya Rani et al., and Johnson et al. The income status of the patient contributes to financial worries (P < 0.05) as the majority population in our study were treated with either insulin (41.2%) or insulin with combination of OHA (34.6%) which have synergistic effect on the economic burden of the lower economic class.
Diabetic therapy and with financial worries and diet satisfaction
Our findings indicate that the T2DM patients who received more intensive therapy with insulin or insulin combination with OHA were associated with more impaired QoL in most of the domains as compared to patients who received less intensive therapy with OHA monotherapy or combination of one or more OHA, which is parallel to the findings conducted by Huang et al. and Johnson et al. The diabetic treatment had significant correlation with domains of financial worries and diet satisfaction (<0.05). Treatment was found to be statistically associated with diet satisfaction (P = 0.0145) in our study, but this finding was contradictory to the Sandhya Rani et al. study where mean QoL scores of dietary satisfaction in allopathic treatment were comparatively higher as compared to herbal medicines.
Complications correlation with symptom botherness
In this study, diabetes-associated complications played a significant role in health-related QoL by significant effect on symptom botherness, which was similar to the studies conducted by Redekop et al., wherein the presence of diabetes-related complications have contributed to lower QoL. The reason is considered to be diabetes patient being an elderly is in higher incidence to get various complications and multiple organs get affected which contribute to various related symptoms. The overall QoL is thus determined as an additive of both the complications associated and diabetes-related botherness which is found to be further decreased on determination.
Variables and its domains with noncorrelation
In this study, there was no correlation associated with any variables in the domains of the role limitation due to physical health and physical endurance. This finding was inconsistent to that of the cross-sectional studies conducted in Japan, Bangladesh, Korea, and Singapore where there was significant association of mobility and self-care in determination of QoL in T2DM patients. Despite the results of number of previous studies,,,,,, no significant association between age, social habits, duration of diabetes, and complications with QoL was found; the reason to which is diabetic patients get adapted to the fact of disease and its associated complication. The study findings are similar to the study conducted in Greece except there was no correlation with age parameter. Finally, we found weak association between quantitative variables such as glycemic control (HbA1C, RBS) and QoL, a finding in agreement with number of other analyses, and in contrast to data reported by Somappa et al. who found that improved glycemic control was associated with impervious improvement in QoL.
There were certain limitations to our study;first and foremost is the generalizability of the study is limited as the study site is a tertiary care hospital with small sample size and study conducted for shorter duration of period. Second, the time taken by the elderly to respond due to many associated factors also led to biasness. Finally, the scarcity of studies carried to assess the QoL in diabetic patients in Indian scenario; there were difficulties in comparing and interpreting the variables in our study population.
| Conclusion|| |
The current study is one of the fewer studies in India assessing QoL of diabetics' using an “Indian” instrument. We found following parameters to have statistical association with different QoL domains – family history of diabetes, presence of hypertension, BMI, educational status, marital status, income status, treatment type, and complications. We recommend assessment of QoL as a part of diabetes treatment modality. Although this study provides interesting results in Indian patients, further QoL studies are needed in the country to better explore the area and helping policy-makers.
We would like to thank all the people including patients, doctors, and nurses who helped us in the completion of the study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: Estimates for the year 2000 and projections for 2030. Diabetes Care 2004;27:1047-53.
Joshi SR, Parikh RM. India – Diabetes capital of the world: Now heading towards hypertension. J Assoc Physicians India 2007;55:323-4.
Timar R, Velea I, Timar B, Lungeanu D, Oancea C, Roman D, et al.
Factors influencing the quality of life perception in patients with type 2 diabetes mellitus. Patient Prefer Adherence 2016;10:2471-7.
Nagpal J, Kumar A, Kakar S, Bhartia A. The development of 'quality of life instrument for Indian diabetes patients (QOLID): A validation and reliability study in middle and higher income groups. J Assoc Physicians India 2010;58:295-304.
Stegenga H, Haines A, Jones K, Wilding J; Guideline Development Group. Identification, assessment, and management of overweight and obesity: Summary of updated NICE guidance. BMJ 2014;349:g6608.
American Diabetes Association. Standards of medical care in diabetes-2015 abridged for primary care providers. Clin Diabetes 2015;33:97-111.
Saleh F, Ara F, Mumu SJ, Hafez MA. Assessment of health-related quality of life of Bangladeshi patients with type 2 diabetes using the EQ-5D: A cross-sectional study. BMC Res Notes 2015;8:497.
Akinci F, Yildirim A, Gözü H, Sargin H, Orbay E, Sargin M. Assessment of health-related quality of life (HRQoL) of patients with type 2 diabetes in Turkey. Diabetes Res Clin Pract 2008;79:117-23.
Redekop WK, Koopmanschap MA, Stolk RP, Rutten GE, Wolffenbuttel BH, Niessen LW, et al.
Health-related quality of life and treatment satisfaction in Dutch patients with type 2 diabetes. Diabetes Care 2002;25:458-63.
Martínez YV, Prado-Aguilar CA, Rascón-Pacheco RA, Valdivia-Martínez JJ. Quality of life associated with treatment adherence in patients with type 2 diabetes: A cross-sectional study. BMC Health Serv Res 2008;8:164.
Nyanzi R, Wamala R, Atuhaire LK. Diabetes and quality of life: A Ugandan perspective. J Diabetes Res 2014;2014:402012.
Varghese RT, Salini R, Abraham P, Reeshma KK, Vijayakumar K. Determinants of the quality of life among diabetic subjects in Kerala, India. Diabetes Metab Syndr Clin Res Rev 2007;1:173-9.
Papazafiropoulou AK, Bakomitrou F, Trikallinou A, Ganotopoulou A, Verras C, Christofilidis G, et al.
Diabetes-dependent quality of life (ADDQOL) and affecting factors in patients with diabetes mellitus type 2 in Greece. BMC Res Notes 2015;8:786.
Yildiz E, Aşti T. Determine the relationship between perceived social support and depression level of patients with diabetic foot. J Diabetes Metab Disord 2015;14:59.
Shim YT, Lee J, Toh MP, Tang WE, Ko Y. Health-related quality of life and glycaemic control in patients with type 2 diabetes mellitus in Singapore. Diabet Med 2012;29:e241-8.
Didarloo A, Alizadeh M. Health-Related Quality of Life and its Determinants among Women with Diabetes Mellitus: A Cross-Sectional Analysis. Nurs Midwifery Stud 2016;5:e28937.
Kumar P, Krishna M. Quality of Life in Diabetes Mellitus. Science Journal of Public Health. Vol. 3, No. 3, 2015. p. 310-3. doi: 10.11648/j.sjph.20150303.12.
Sandhya Rani M, Pippalla SR, Mohan G, Gaikwad BS, Prasad B. A comparative quality of life assessment of herbal drugs with allopathic drugs for the treatment of diabetic complications. Pharm Crops 2014;5:77-84.
Johnson JA, Maddigan SL. Performance of the RAND-12 and SF-12 summary scores in type 2 diabetes. Qual Life Res 2004;13:449-56.
Huang IC, Liu JH, Wu AW, Wu MY, Leite W, Hwang CC, et al.
Evaluating the reliability, validity and minimally important difference of the Taiwanese version of the diabetes quality of life (DQOL) measurement. Health Qual Life Outcomes 2008;6:87.
Sakamaki H, Ikeda S, Ikegami N, Uchigata Y, Iwamoto Y, Origasa H, et al.
Measurement of HRQL using EQ-5D in patients with type 2 diabetes mellitus in Japan. Value Health 2006;9:47-53.
Lee WJ, Song KH, Noh JH, Choi YJ, Jo MW. Health-related quality of life using the EuroQol 5D questionnaire in Korean patients with type 2 diabetes. J Korean Med Sci 2012;27:255-60.
Alcubierre N, Rubinat E, Traveset A, Martinez-Alonso M, Hernandez M, Jurjo C, et al.
Aprospective cross-sectional study on quality of life and treatment satisfaction in type 2 diabetic patients with retinopathy without other major late diabetic complications. Health Qual Life Outcomes 2014;12:131.
Shaheen F, Basit K, Riaz M, Hakeem R, Basit A. Assessing health related quality of life in diabetic subjects by SF 36 questionnaire in a tertiary care diabetes unit of Karachi, Pakistan. Int J Adv Res 2014;2:13-7.
Roy K, Iyer U. Assessment of quality of life type 2 diabetes patients with newly diagnosed non alcoholic fatty liver disease using quality of life instrument for Indian diabetic patients. J Soc Health Diabetes 2014:2:87-91.
Anumol Mathew A, Anusree T, Aparna Mathew A, Archana S, Athira M, Sachina B. et al
. Quality of life among type-II diabetes mellitus patients in South India: A descriptive study. Am Int J Res Humanit Arts Soc Sci 2014;7:197-200.
Somappa HK, Venkatesha M, Prasad R. Quality of life assessment among type 2 diabetic patients in rural tertiary centre. Int J Med Sci Public Health 2014;3:415-7.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]