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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).
To translate, cross-culturally adapt, validate and psychometrically test the MISSCARE Survey–Patient for assessing patients' perspectives on missed nursing care (MNC) in a Danish hospital setting.
A two-phase cross-cultural adaptation and psychometric validation study.
The study was conducted in two phases. First, the MISSCARE Survey–Patient was cross-culturally adapted to ensure its relevance in a Danish hospital context. This phase involved translation and back-translation, expert committee reviews and cognitive interviews with 18 inpatients to establish content validity. Second, a convenience sample of 284 patients from surgical and medical departments completed the adapted survey. Psychometric properties were evaluated using structural equation modelling to test a second-order formative model.
The cross-cultural adaptation phase led to minor and substantial revisions, including the addition of six new items to enhance content validity. These items addressed aspects of nursing care relevant to patients in the contemporary hospital setting that were not captured by the original survey. Structural equation modelling confirmed the second-order formative model and demonstrated robust psychometric properties.
The MISSCARE Survey–Patient was successfully adapted and validated for use in Danish hospitals, ensuring strong content validity and psychometric robustness.
The Danish version of the survey provides a valuable tool for assessing MNC from patients' perspectives in hospital settings. Its use can help identify specific areas where nursing care falls short, guiding targeted initiatives to enhance care quality and patient safety. By integrating patients' experiences into quality improvement initiatives, the survey supports the development of more person-centred care practices.
The study adhered to the COnsensus-based Standards for the selection of health Measurement INstruments reporting guideline for studies on measurement properties of patient-reported outcome measures.
Patients were not involved in the study's design, conduct, or reporting.
The Danish version of the survey facilitates data collection on patients' perspectives of MNC in contemporary hospital settings, providing valuable insights into care quality. By offering a validated tool to assess MNC from patients' perspectives, the survey helps hospitals identify care gaps, prioritise improvement efforts and enhance person-centred care.
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