Effectiveness of using manual pill organizers and pill reminder apps in improving medication adherence and health outcomes in the Indian elderly population receiving multiple medications (PORA-MEDAdhere): Protocol for a 2*2 factorial randomized controlled trial

IntroductionPoor medication adherence is associated with poor clinical outcomes, an increase in hospitalisations, and increased mortality. This is a multi-center 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 amongst Indian elderly individuals taking multiple medications. ObjectivesThe primary objective of this study is to evaluate the impact of MPO and PRA alone or in combination in improving medication adherence amongst 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 costutility of improving medication adherence. Methods and analysisThis is a community-based, open-label, factorial-design randomized 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 six months and having access the 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 (MARS-5), seven-day point prevalence of medication non-adherence and pill count]; morbidity profile; health care utilisation; health-related quality of life; cost-effectiveness and cost-utility outcomes. Ethics and disseminationThe 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. Trial registration numberCTRI/2024/01/061975 [Registered on-29/01/2024]. Strengths and limitationsO_LIThe study provides the first clinical evidence of the effectiveness of locally developed pill reminder apps and manual pill organisers in improving adherence in Indian elderly individuals with non-communicable diseases. C_LIO_LIThe study incorporates rural and urban populations from two geographically different sites in India, enhancing its representativeness C_LIO_LIThe study evaluates the interventions impact on the morbidity profile, healthcare utilisation, quality of life, and includes cost-effectiveness and cost-utility analyses C_LIO_LIThe factorial design enables evaluation of the individual and combined intervention effects against the control C_LIO_LILimited literacy among rural elderly people and lowlow Android phones availability are expected challenges and limitations in implementation C_LIO_LIThe study relies on multiple outcomes to assess medication adherence due to the lack of a gold standard and the subjectivity of its measurement. C_LI