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CTRI Number  CTRI/2025/08/093229 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assessment of Home medication review on Quality of life, cost, Medication adherence and glycemic control among Elderly Type-2 Diabetic patients  
Scientific Title of Study   Impact of Pharmacist-led Home Medication Review on Economic, Clinical, and Humanistic Outcomes in Elderly Type-2 Diabetic Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Radhakishan M 
Designation  PhD Research scholar 
Affiliation  NGSM Institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8129415480  
Fax    
Email  psradhakishan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Adithi Kellarai 
Designation  Associate Professor 
Affiliation  Dept. of General Medicine, Justice K.S. Hegde Charitable Hospital, NITTE (Deemed to be University) 
Address  Justice K.S. Hegde Charitable Hospital, Deralakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9886517329  
Fax    
Email  adithibhandary@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Uday Venkat Mateti 
Designation  Associate Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University) 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8152977460  
Fax    
Email  udayv@nitte.edu.in  
 
Source of Monetary or Material Support  
NITTE (Deemed to be University), 6th Floor, University Enclave, Medical Sciences Complex, Deralakatte, Mangaluru - 575018 Karnataka, India  
 
Primary Sponsor  
Name  NITTE (Deemed to be University) 
Address  6th Floor, University Enclave, Medical Sciences Complex, Deralakatte, Mangaluru, Karnataka 575018 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Adithi Kellarai  Justice K.S. Hegde Charitable Hospital  Department of General Medicine and Endocrinology, Ground floor Deralakatte, Mangalore – 575018, Karnataka, India
Dakshina Kannada
KARNATAKA 		 9886517329

adithibhandary@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee, Nitte University   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pharmacist led Home Medication Review (HMR)  A trained pharmacist visits patients in their homes to review medications, provide education, and identify and address drug-related problems (DRPs) for a duration of 1 year from the date of recruitment.  
Comparator Agent  Standard Care  The control group will receive only standard care, which includes routine medical consultations, prescriptions, and general diabetes management advice provided at Justice K.S. Hegde Charitable Hospital and collaborating Primary Health Centres (PHCs) and They will not receive pharmacist-led Home medication reviews. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients aged 60 years or above.
Diagnosed with Type 2 Diabetes Mellitus.
Currently undergoing standard pharmacotherapy for diabetes management.
Willing to provide informed consent and participate in the study 
 
ExclusionCriteria 
Details  Patients with terminal illnesses.
Patients with severe complications of diabetes, such as end-stage renal disease, may be excluded from participation.
Patients with psychiatric illnesses or cognitive impairments.
Patients with a history of stroke that significantly limits their ability to engage in the intervention or adhere to the study protocol.
Uncontrolled comorbidities require immediate intensive care.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in glycemic control as measured by HbA1c levels.  Baseline, 6 months, and 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in medication adherence, and Change in quality of life.  Baseline, 6 months, and 12 months. 
Change in direct medical costs, including hospital visits and medication expenses and Number and category of Drug-Related Problems (DRPs) identified and addressed.  Baseline, 6 months, and 12 months. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/09/2025 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [psradhakishan@gmail.com].

  6. For how long will this data be available start date provided 01-12-2026 and end date provided 31-12-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a randomised parallel-group controlled trial designed to evaluate the impact of pharmacist-led Home Medication Review on clinical economic and humanistic outcomes in elderly patients with Type 2 Diabetes Mellitus. A total of 200 patients aged 60 years and above will be recruited. Participants will be randomly allocated in a 1 to1 ratio to either an intervention group receiving pharmacist-led HMR in addition to standard care or a control group receiving standard care only. The HMR intervention consists of structured home visits by a pharmacist to review medications, provide patient education, and collaborate with physicians to resolve drug-related problems. 
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