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临床试验/CTRI/2025/10/096484
CTRI/2025/10/096484尚未招募不适用

Exploring barriers and facilitators to medication adherence among geriatric patients with polypharmacy: a qualitative study using the theoretical domains framework

NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Sciences1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年11月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
28
试验地点
1
主要终点
The study is expected to identify key patient- and provider-level barriers and facilitators to medication adherence in geriatric patients with polypharmacy.

研究概览

简要总结

Background and Need for the Study

Medication adherence is critical for managing chronic diseases in older adults; however, nonadherence is common, especially among those with polypharmacy. In India, the contributing factors include low health literacy, financial constraints, caregiver dependence, cultural beliefs, and irregular access to medicines. Although prior studies have identified some barriers, the deeper behavioural, social, and systemic determinants remain poorly understood, particularly from the patient and provider perspectives. The Theoretical Domains Framework (TDF) offers a structured, evidence based approach to explore these influences across the cognitive, behavioural, social, and environmental domains. Its application in the Indian geriatric context can yield culturally relevant insights to guide targeted and sustainable interventions that improve adherence in this vulnerable population.

Objectives

To identify and map barriers and facilitators influencing medication adherence among older adults with polypharmacy in India, incorporating perspectives from both patients and healthcare providers, using TDF as the analytical framework.

Methods

A qualitative study will be conducted over a six-month period (September 2025 to February 2026) in the Department of General Medicine, Justice K.S. Hegde Charitable Hospital, Mangaluru, with participants drawn from both urban and rural healthcare settings. Geriatric patients (over 60 years) taking five or more chronic medications will be recruited purposively, alongside healthcare providers involved in their care. Approximately 15 to 20 patients and 5 to 8 healthcare providers will be interviewed until thematic saturation is reached.

Data Analysis

Thematic analysis will be conducted using the TDF domains as the coding framework. Two independent researchers will code the data collected. Discrepancies in coding will be resolved through discussion, and if an agreement cannot be reached, a third researcher will make the final decision. To ensure methodological rigour, we will use investigator triangulation (involving multiple researchers in analysis), data source triangulation (drawing on patient interviews, provider interviews, and case records), and maintain a detailed audit trail documenting coding and analytical decisions

Expected Outcome

This study is expected to generate a rich, domain specific understanding of the cognitive, behavioural, social, and environmental factors influencing medication adherence. Comparative analysis will highlight both shared and unique determinants between patients and providers, with particular attention to culturally relevant facilitators and modifiable barriers that can be addressed through targeted interventions in the future.

Conclusion

By applying the TDF to the Indian geriatric polypharmacy context, this study will fill a critical evidence gap in the literature. The findings will provide actionable insights to inform the design of targeted, context sensitive, and sustainable interventions that strengthen medication adherence, thereby contributing to improved therapeutic outcomes and quality of life among India’s aging population.

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients: Age more than or equal to 60 years At least one lifestyle diseases On long-term multiple medications Able to provide informed consent and communicate in English, Kannada, or Malayalam Healthcare Providers: Involved in geriatric care and medication counselling Willing to participate in the interview.

排除标准

  • Terminally ill patients Patients with severe cognitive impairment In patients & ICU patients Those unwilling or unable to participate.

结局指标

主要结局

The study is expected to identify key patient- and provider-level barriers and facilitators to medication adherence in geriatric patients with polypharmacy.

时间窗: Baseline

次要结局

  • Insights will guide the(development of context-specific, evidence-based interventions.)

研究者

发起方
NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Sciences
申办方类型
Other [Educational Institution ]
责任方
Principal Investigator
主要研究者

Spoorthi Sunil

NGSM Institute of Pharmaceutical Sciences

研究点 (1)

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