Description:
a) Background:
Global population of individuals aged 60 years and older is set to double by 2050, reaching approximately 2.1 billion. Additionally, it is anticipated that the number of individuals aged 80 years or older will triple between 2020 and 2050, reaching an estimated 426 million [1]. The National Policy for Older Persons 1999 defines elderly or senior citizens as individuals aged over 60 years [2]. The older population in India is experiencing an average annual growth rate nearly three times higher than the overall population growth rate. Presently, India is home to the world's second-largest elderly population, with around 140 million people aged 60 and above [3]. Data from the National Commission on Population of India indicates that the geriatric population currently constitutes approximately 9% of the total population, and projections suggest it may double to 18% by the year 2036 [1]. This increasing geriatric population requires comprehensive health policies to provide happy and self-reliant lives to senior citizens. The Indian government has initiated several schemes aimed to ensure happy, healthy and self-reliance lives of senior citizens [4].
Review of literature consisting of previous studies done on the same area of work stating potential risks and benefits and outcome measures
An increase in longevity and a decrease in mortality in old age leads to an increase the multiple comorbid conditions, which is commonly known as ‘Multimorbidity’ [5]. Literature has suggested that there is a strong positive association between age and the prevalence of multimorbidity in India. Various surveys conducted in different states of India have shown a high prevalence of multiple comorbidities particularly non-communicable diseases (NCDs) in the elderly population across the county.
A study conducted in different states of India has reported 23.3% prevalence of multimorbidity in elderly population. Highest (42%) was reported in Kerala followed by Punjab (36%) and Maharashtra (24%) [6]. Survey conducted in Allahabad district showed a 31% multimorbidity prevalence in elderly [7]. The Longitudinal Aging Study in India (LASI) stands as one of the largest surveys conducted in the country, providing insights into the prevalence of disease-specific multimorbidity across India and its prominent states. According to LASI findings, multimorbidity rates vary, with chronic heart disease showing the highest prevalence (91%), followed by cholesterol-related conditions (89.2%), arthritis (70.5%) and angina (64.8%) [8].
Geriatric patients face a multitude of risk factors that can significantly impact their health and well-being. Some of the most prominent risk factors include: the presence of chronic health conditions which can increase the complications, Aging often leads to a decline in physical strength, mobility, and balance, which can increase the risk of falls and fractures, age-related cognitive decline and dementia which increases dependency and vulnerability, Poor nutrition and malnutrition that increases susceptibility to infections and other health complications and use of multiple medications to manage chronic conditions that can increase the risk of adverse drug reactions, drug interactions, and medication non-adherence [9].
Proper medication adherence is important for optimal treatment outcomes and preventing complications and hospitalizations. Poor medication adherence is one of the strongest predictors of all-cause mortality in patients with chronic diseases [10]. Poor medication adherence is very common in geriatric patients. Taking multiple medications to treat chronic diseases and the high prevalence of cognitive impairments make medication adherence challenging for geriatric patients [11].
Various surveys conducted in different parts of India have shown poor medication adherence in older patients. One study conducted in a tertiary care hospital, in Mangalore reported that only 72% of patients adhered to their ant-diabetic medicines [12]. Another study conducted in Ooty, India found the prevalence of non-adherence as 61.38% [13]. Similar study conducted in Manipal, Karnataka reported that 55.6% of elderly patients were not adherent to their medications [14]. Study conducted in Hyderabad, India also reported that only 27.14% of elderly patients showed good adherence to their medications [15]. A similar study conducted in Coimbatore, India reported that more than half (51.1%) of geriatric patients had low adherence to their medications [16]. All these studies have suggested that medication adherence is a common problem in elderly patients which could be due to various factors. Studying the challenges that elder patients face in accessing healthcare services and treatment adherence is crucial to improving overall health outcomes, reducing healthcare cost and promoting healthy ageing in overall. Therefore we have taken this study to develop a registry regarding challenges that the elderly face with respect to accessing health care as well as long term adherence.
b) Aim/objective
In elderly people (≥60 years) with select chronic diseases visiting St John's hospital and its associated health services :
c) Methods:
Study Design:
A cross sectional study, proposed to be conducted in the hospital and its associated health services . Study will include patients aged 60 years, and above , with select chronic diseases, from both out-patients and in-patient departments.Data collection will include a one-year retrospective data also. This study will help us to understand the patient characteristics, medication adherence patterns and determinants of outcomes in the elderly population.
Inclusion & Exclusion criteria
Inclusion criteria
Consenting patients aged 60 years and above and have the following chronic diseases will be included
Exclusion criteria
No exclusion criteria
Study setting:
We will include patients from from OPDs of general medicine, geriatric medicine and community medicine servicesand in-patients from all the departments across the hospital.
Duration of the study:
a. The total duration of the study: 6 months
b. Time taken for each subject
Patients > 60 with the above mentioned selected chronic diseases will be invited to participate in a detailed data collection. This will take about 30 minutes.
Study Participants:
We will include all consenting patients who are 60 years and above. Patients will be recruited from all from OPDs of general medicine, geriatric medicine and community medicine services and in-patients from all the departments across the hospital. We will invite all the eligible elderly patients from the above mentioned OPDs and in-patient wards. In the rural center we will recruit patients through the associated health services of community medicine department.
Sampling Frame:
All eligible patients from out-patient departments of general medicine, geriatric medicine and community medicine and their associated health services and in-patients from all the departments across the hospital.
We will invite all the eligible elderly patients to participate in the data-collection.
In the OPDs, the physicians will identify the patients and send them to the study team seated in the common waiting area. In the in-patient wards, the treating physicians will be approached for identifying and consenting the eligible participants and data collection will be done by the study team at the bedside.
Data collection:
Study will be conducted on both out-patients and In-patients. In consenting patients, we will collect data on baseline characteristics such as age, gender, location, socioeconomic status, history of present disease, as well as any co-morbid conditions, investigations applicable to each case, treatment received in the hospital during this visit. This form will collect data on reasons, if any for poor adherence in the previous one year.
Data Handling
The data will be recorded on a structured case report form (CRF). These will be then transferred on Epi-info, which is a free database software.
Ethical Considerations, Patient Confidentiality, and Consent
This study will be conducted in compliance with the protocol, principles laid down in the Declaration of Helsinki. Before study initiation, the Investigator will obtain approval from the Institutional Ethics Committee (IRB/IEC) for the protocol and consent and assent forms.
Ethics approvals from the St. John’s Medical College IEC will be obtained. We will obtain written informed consent from patients in this study. All participants’ data will be maintained with the utmost confidentiality and only authorized personnel will have access to study documents. All documents will contain de-identified data from the participants.
Data management:
Data will be collected on paper case record forms. We will set up a database at St. John’s Medical College and Research Institute. The data will be stored on a secure server with adequate backup. All patient information will be stored on a password secured computer system and kept strictly confidential. Subject confidentiality will be further ensured by utilizing subject identification code numbers.
e) Sample size:
In the study of Yuvaraj et.al the reported prevalence of Nonadherence to medication among elderly (>60 years old) patients is 32.7%. Hence to estimate the prevalence of non-adherence of medication with a relative precision of 10% and 95% confidence interval the required minimum sample size is 816 elderly patients.
We add 20% non-response rate the total sample size will be 984 and we will round off to 1000 patients.
Calculation:
| Single Proportion - Absolute Precision | |
| Expected Proportion | 0.32 |
| Relative Precision (%) | 10 |
| Desired confidence level(1- alpha) % | 95 |
| Required sample size | 816 |
f) Study update:
Data collection started from: 23rd June
Till now, a total of 2000 samples were recruited, out of which 930 are from IPD and 1000 were from OPD.
Updated on July 2025