| CTRI Number |
CTRI/2025/10/096484 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
25/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding what affects how well older adults take their medicines when they have to use many medications |
|
Scientific Title of Study
|
Exploring barriers and facilitators to medication adherence among geriatric patients with polypharmacy: a qualitative study using the theoretical domains framework |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Spoorthi Sunil |
| Designation |
Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6364568107 |
| Fax |
|
| Email |
spoorthisunil2210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praneetha Jain |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8431480836 |
| Fax |
|
| Email |
praneetha.jain@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praneetha Jain |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8431480836 |
| Fax |
|
| Email |
praneetha.jain@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| NITTE (Deemed to be University) Deralakatte, Mangaluru, 575018 |
|
|
Primary Sponsor
|
| Name |
NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Sciences |
| Address |
Deralakatte, Mangaluru, 575018 |
| Type of Sponsor |
Other [Educational Institution ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pratheeksha Rai G |
Justice K S Hegde Charitable Hospital |
Department of General Medicine, Deralakatte, Mangaluru- 575018
Dakshina Kannada
KARNATAKA |
9945609818
partty.pr@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
Terminally ill patients
Patients with severe cognitive impairment
In patients & ICU patients
Those unwilling or unable to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study is expected to identify key patient- and provider-level barriers and facilitators to medication adherence in geriatric patients with polypharmacy. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Insights will guide the
development of context-specific, evidence-based interventions. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |