Poor medication adherence is associated with poor clinical outcomes, an increase in hospitalisations and increased mortality. This is a multicentre randomised study that evaluates the effectiveness of using a manual pill organiser (MPO) and a custom-developed pill reminder app (PRA) on medication adherence, morbidity, as well as health economic outcomes among Indian elderly individuals taking multiple medications.

The primary objective of this study is to evaluate the impact of MPO and PRA alone or in combination in improving medication adherence among elderly individuals on multiple medications. The secondary objectives include the impact of interventions on the morbidity profile and health-related quality of life. The study also plans to assess the cost-effectiveness and cost-utility of improving medication adherence.

This is a community-based, open-label, factorial-design randomised controlled trial to be conducted across rural and urban populations at two geographically distinct sites in India. The study will enrol 752 elderly individuals aged 60–80 years, receiving three or more medications for at least 6 months and having access to smartphones. The participants will be randomised to receive one of the following interventions for 12 months: control group, PRA, MPO and MPO+PRA. All study groups would receive patient education about the importance of medication adherence. The study outcomes include the proportion of improvement in medication adherence (using Medication Adherence Rating System-5, 7-day point prevalence of medication non-adherence and pill count); adverse clinical outcomes; healthcare utilisation; health-related quality of life; cost-effectiveness and cost-utility outcomes.

The study protocol has been approved by institutional ethics committees at all three institutes. The study results for primary and secondary outcomes will be published in peer-reviewed journals.

CTRI/2024/01/061975 (Registered on: 29 January 2024).

This study aimed to analyse the number of myocardial infarction (MI) admissions during the COVID-19 lockdown periods of 2020 and 2021 (March 15th to June 15th) and compare them with corresponding pre-pandemic period in 2019. The study also evaluated changes in critical treatment intervals: onset to door (O2D), door to balloon (D2B) and door to needle (D2N) and assessed 30-day clinical outcomes. This study examined MI care trends in India during the COVID-19 lockdown period, irrespective of patients’ COVID-19 infection status.

Multicentre retrospective cohort study

Twenty-three public and private hospitals across multiple Indian states, all with 24/7 interventional cardiology facilities.

All adults (>18 years) admitted with acute myocardial infarction between March 15 and June 15 in 2019 (pre-pandemic), 2020 (first lockdown) and 2021 (second lockdown). A total of 3614 cases were analysed after excluding duplicates and incomplete data.

Number of MI admissions, median O2D, D2B and D2N times.

30-day outcomes including death, reinfarction and revascularisation.

MI admissions dropped from 4470 in year 2019 to 2131 (2020) and 1483 (2021). The median O2D increased from 200 min (IQR 115–428) pre-COVID-19 to 390 min (IQR 165–796) in 2020 and 304 min (IQR 135–780) in 2021. The median D2B time reduced from 225 min (IQR 120–420) in 2019 to 100 min (IQR 53–510) in 2020 and 130 min (IQR 60–704) in 2021. Similarly, D2N time decreased from 240 min (IQR 120–840) to 35 min (IQR 25–69) and 45 min (IQR 24–75), respectively. The 30-day outcome of death, reinfarction and revascularisation was 4.25% in 2020 and 5.1% in 2021, comparable to 5.8% reported in the Acute Coronary Syndrome Quality Improvement in Kerala study.

Despite the expansion of catheterisation facilities across India, the country continues to fall short of achieving international benchmarks for optimal MI care.

Using the community-based participatory research (CBPR) methodology, sustained peer group treatment has effectively improved medication adherence. Although many studies investigate the effectiveness of peer group therapy, there is a lack of evidence addressing the cost-effectiveness of CBPR models in low- and middle-income countries. This protocol outlines the methods for the economic evaluation of the PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hyperTEnsion (PARTICIPATE) trial to determine whether the CBPR approach to enhance medication adherence among patients with diabetes and/or hypertension is cost-effective in India.

A within-trial cost-effectiveness analysis (CEA) from a societal perspective will be conducted alongside a multicentre cluster randomised controlled trial to identify, measure and evaluate the key resource and outcome impacts of a CBPR model compared with usual care aimed at improving medication adherence in adult rural Indian patients with diabetes and/or hypertension. The CEA will provide results in terms of the cost per improvement in medication adherence score, and a cost-utility analysis (CUA) will express the findings as the cost per disability-adjusted life year (DALY) or quality-adjusted life year (QALY) gained. Intervention costs and effects will be projected for the population of Indian adults with diabetes and/or hypertension who are on medication, analysed over the cohort’s lifetime. Results from the modelled CUA will detail incremental costs, costs per death averted and costs per DALY averted/QALY gained for the interventions relative to the comparator. Incremental cost-effectiveness ratios will be computed by dividing the cost difference between the intervention and comparator by the difference in benefits. Health economic evaluation methods, including a lifetime horizon, a 3% discount rate for costs and benefits and a societal perspective, will be followed. The effects of sampling uncertainty on estimated incremental costs and effectiveness parameters, as well as the influence of methodological assumptions (such as the discount rate and study perspective), will be examined through both deterministic and probabilistic sensitivity analyses. Relevant differences in costs, outcomes or cost-effectiveness disparities among subgroups of patients with varying baseline characteristics will also be reported. Results will be illustrated using cost-effectiveness acceptability curves across a range of willingness-to-pay thresholds. Modelled CUA will broaden the target population and time frame to offer decision-makers insights into the cost-effectiveness of the CBPR approach for enhancing medication adherence. Furthermore, a return on investment analysis will be performed to express benefits in monetary terms relative to investments made, allowing for a comprehensive expression of both costs and the full spectrum of intervention benefits in monetary units.

The Institutional Ethics Committee of Sri Aurobindo Medical College and PGI, Indore, provided ethics approval. The results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal and disseminated through reports to Indian Council of Medical Research and conference presentations.

Clinical Trial Registry of India (CTRI) CTRI/2024/01/061939.