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CTRI Number  CTRI/2023/10/058703 [Registered on: 16/10/2023] Trial Registered Prospectively
Last Modified On: 12/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized Factorial Trial 
Public Title of Study   Medication Adherence in Geriatrics with Type 2 Diabetes through Real Time Medication Monitoring and Clinical Pharmacological Reconciliation 
Scientific Title of Study   Evaluation of Medication Adherence in Geriatric Patients with Type 2 Diabetes through Real time Monitoring & Clinical Pharmacological Reconciliation: A Multi-Centre Randomized Controlled Trial  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shambo Samrat Samajdar 
Designation  Senior Resident 
Affiliation  School of Tropical Medicine Kolkata 
Address  Dept of CLinical Pharmacology School of Tropical Medicine 108 C R Avenue Kolkata

Kolkata
WEST BENGAL
700073
India 
Phone    
Fax    
Email  shambo_sa2001@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Shatavisa MUkherjee 
Designation  Doctoral Scholar 
Affiliation  School of Tropical Medicine 
Address  Dept of CLinical Pharmacology School of Tropical Medicine 108 C R Avenue Kolkata

Kolkata
WEST BENGAL
700034
India 
Phone  7003776138  
Fax    
Email  shatavisa100@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shatavisa MUkherjee 
Designation  Doctoral Scholar 
Affiliation  School of Tropical Medicine 
Address  Dept of CLinical Pharmacology School of Tropical Medicine 108 C R Avenue Kolkata

Kolkata
WEST BENGAL
700034
India 
Phone  7003776138  
Fax    
Email  shatavisa100@gmail.com  
 
Source of Monetary or Material Support  
Allergy and Asthma Research Centre 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shambo Samrat Samajdar  Allergy and Asthma Research Centre Kolkata  Room 2, 48, 7, Purna Das Rd, Golpark, Hindustan Park, Gariahat, Kolkata, West Bengal 700029
Kolkata
WEST BENGAL 		 9831892425

shambo_sa2001@yahoo.co.in 
Shambo Samrat Samajdar  Allergy and Asthma Treatment Centre Moulali  89, A. J. C. Bose Road, Market, opp. Entally, Maula Ali, Kolkata, West Bengal 700014
Kolkata
WEST BENGAL 		 9831892425

shambo_sa2001@yahoo.co.in 
Shambo Samrat Samajdar  Diabetes Allergy Asthma Therapeutic Specialty Clinic  F F2 Hatiara Road Baguihati Kolkata - 700059
Kolkata
WEST BENGAL 		 9831892425

shambo_sa2001@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics Committe - Allergy and Asthma Research Centre  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clinical Pharmacological Reconciliation  CPRRF consists of following strategies as: 1. Evaluating if the duly prescribed medicine is unnecessary or redundant, or no or a wrong medicine is prescribed for a given indication; 2. De-prescribing of medicines that are unnecessary or redundant or contraindicated or not well tolerated; 3.Identifying omissions and commissions during transition of care; 4. Tailoring the dose adjusting to the individual need and perspectives 5. Preventing, minimizing and managing adverse drug reactions (ADRs); 6.Improving treatment adherence; 7. Considering affordability and availability of medicines vis-à-vis adherence 8. Individualization of treatment accommodating patient factors; 9.Rationalising polypharmacy; 10.Enhancing quality of life. 
Intervention  Medicinal Adherence Kit Development: MedpeR - personal Medicinal helper   Medicinal Adherence Kit Development: MedpeR - personal Medicinal helper  
Comparator Agent  Standard of Care   Standard of Care for 12 months 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients with T2DM on oral antidiabetic agents having a having a medication adherence rate of less than 80% in the last 12 months  
 
ExclusionCriteria 
Details  Those patient with T2DM on oral antidiabetic agents having a medication adherence rate of more than 80% in the last 12 months  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Medication adherence rate (pill counting method)  Every three months, for a period of one year 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse Drug Reactions  Every three months, for a period of one year 
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
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   Phase 4 
Date of First Enrollment (India)   20/10/2023 
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="1"
Months="0"
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Anyone

  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 [shambo_sa2001@yahoo.co.in].

  6. For how long will this data be available start date provided 01-11-2024 and end date provided 01-09-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Incorporating medication adherence devices and/or clinical pharmacological interventions in addition to standard of care may lead to improved medication adherence and better glycemic control in elderly patients with T2DM on oral anti-diabetic medications. With this in view, the present study aims to evaluate the effect of medication adherence tool and clinical pharmacological reconciliation in improving medication adherence among geriatric patients with type 2 diabetes mellitus (T2DM) attending the OPD. 
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