Evaluation of an active focused intervention on the quality of life among elderly individuals in the slum areas of Thane district in India: An experimental field-based randomized clinical trial

Study design and ethics

The present study was a prospective study carried out in a slum area (Mira) in Mumbai, a metropolitan city in India. We used epidemiological two groups pre- and post-intervention test research design. The key epidemiological and health indicators of the Mira area are listed in Table 1. We carried out the study after obtaining approval from the Institutional Ethics Committee and consent from the study participants between January 2016 and November 2017. The study was carried out in adherence to the latest Declaration of Helsinki guidelines.

Study procedure

Those aged 60 years and above residing in the above-mentioned area for at least six months were included in this study after obtaining their consents. Those who were either bedridden or with serious illness were excluded. Following details were collected from the study participants: age, sex, education, occupation, monthly income, family background, beneficiary of any social security scheme, and concomitant disorders. The interventional group was provided a special attention that included the following:

Providing health check-up for two times at stipulated intervals with multi-disciplinary team and the required medicines,

Personalized counselling and referral to a specialist wherever necessary,

Facilitating the formation of area-wise clubs/social gatherings with identification of their team leaders and organizing meetings at least once a week; and liaison with community-based and non-governmental organizations.

Providing health education on geriatric care to the study participants and their family members and organizing orientation sessions addressing domestic violence, and

Distributing the information brochures regarding various social security measures.

More details about the intervention are provided in the Electronic Supplementary File.

The investigator team approached the study site for obtaining permission and consent from the study participants during the first two visits. From the third visit, the special intervention package was carried out in the intervention group at various stages. During the initial stages, clubs (20 subjects in 1 club) were formed (overall 21 clubs were formed) and the club meetings were facilitated with a total of 12 meetings organized. In the third stage, health checkup camps, and referrals were done. The forth session was the orientation session to the study participants in which orientation to CBOs/SHGs/NGOs (3 times) was provided on topics related to domestic violence, social security, and legal provisions. The fifth session was on the health education on geriatric care to the study participants and their family members that was associated with distribution of brochures. After the fifth session, monitoring and supervision was done in the intervention group every fortnightly. The control group was not provided any of the active intervention other than the standard of care. A pre-validated WHOQoL-BREF questionnaire was used for assessing the QoL that consisted of 26 test items structured under four domains namely, physical, psychological, social and environmental. Raw scores were calculated and were transformed using the following formula: {(actual raw score – least possible raw score)/possible raw score range} X 100. The scale was administered baseline, and after 18 months of providing the intervention.

Demographics

Mean ages of study participants were 64.87 and 64 years in the intervention and control groups. A summary of the demographic characteristics of the study population is listed in [Table 2] wherein majority of them were in the age group of 60-69 years, without formal education, housewives, and economically dependent on their family members. Regarding the health care factors, only the availability of hospital facility was significantly different between the groups with more participants in the intervention group availing private hospitals/clinics and majority did not have any health insurance ([Table 3]). Significantly more participants in the interventional group were had at least one concomitant disorder (intervention group: 311, 73%; control group: 281, 65.97%).

WHO QoL-BREF scores

Internal consistencies as evaluated by Cronbach’s alpha ranged between 0.64 and 0.75, thus demonstrating a good reliability. The QoL scores across all domains were significantly greater post-intervention in the intervention group but not in the control group ([Table 4]). At baseline, baseline QoL scores were significantly (p = 0.001) lower in the intervention group ([Table 5]). Post-intervention (at 18^th month) QoL scores were significantly greater in the intervention group compared but not in the control group ([Table 5]). Literacy, occupation, marital status, monthly income, self earning status, family dependence, access to private hospitals, and concomitant illnesses such as diabetes mellitus, hypertension, ischemic heart disease, respiratory disorders, arthritis, and cataract were the factors significantly different between the groups ([Table 6]).

Statement of key findings

The present study evaluated the QoL and the determining factors in elderly individuals living in a metropolitan city in India. Additionally, a special intervention was provided and its effect on QoL was assessed in comparison to the control group that did not receive the intervention. The QoL scores across all domains were significantly greater post-intervention in the intervention group but not in the control group. Literacy, occupation, marital status, monthly income, self earning status, family dependence, access to private hospitals, and concomitant illnesses such as diabetes mellitus, hypertension, ischemic heart disease, respiratory disorders, arthritis, and cataract were the factors significantly different between the groups.

Comparison with other studies

The current study assessed the effect of specially devised intervention package on quality of life among senior citizens. The results showed a statistically significant difference between pre intervention and post intervention score of WHO physical, psychological, environmental and social quality of life score in the study group. This confirmed that the difference in pre intervention and post-test mean score of WHO quality of life score in the study group is a real difference and not by chance. This supports the effectiveness of the intervention package in improving the score of quality of life (all four domains) of senior citizens in the study group. We observed that the intervention group had significantly greater QoL compared to control group. Key studies addressing a similar hypothesis are summarized in [Table 7] Although the findings were similar to several other studies, those carried out in Iran and in another metropolitan city (Bangalore) revealed a slightly better QoL. Various interventions have been explored for improving the QoL of elderly individuals. A study conducted in Japan by Kamegaya et al. through a randomized controlled trial has shown that a twelve-week physical and leisure activity programtin improving the cognitive function in community-dwelling elderly subjects.^[14] Hariprasad et al. in 2013 evaluated the effects of yoga intervention on quality of life and sleep in the elderly after a period of six month.^[8] The authors in that study observed a significant improvement in the QoL across all domains and sleep. Similarly, Kumar et al. in 2014 through a randomized controlled trial have shown that a novel occupational therapy could improve the QoL of elderly following five weeks of intervention.^[15] We observed that with an advancing age the score of the QOL decrease significantly in all domains in all domains. Contrary to the present study, Kumar P et al.^[7] who have evaluated the elderly living in an urban area in 2013 observed that older age was associated with a poor QoL. This possibly could be attributed to the differences in the physical, psychological and social changes and due to altered immunity amongst the elderly.^[16]

Strengths and limitations

The sample size was sufficiently large (and adequate) compared to several previous studies leading to a better confidence on the obtained results. However, the study is limited in not having a long term follow up with the study participants, and there was no follow up to evaluate the changes in QoL.