| CTRI Number |
CTRI/2025/12/099891 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [mobile application ] |
| Study Design |
Other |
|
Public Title of Study
|
Mobile application Vs conventional diary method on medication adherence among diabetic subjects |
|
Scientific Title of Study
|
Impact of mobile application and conventional diary method on the adherence to the medications among subjects attending Diabetes clinic in a tertiary care center of eastern India: A randomized pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipan Saha |
| Designation |
Senior Resident |
| Affiliation |
School of Tropical Medicine, Kolkata |
| Address |
Dept of Pharmacology,
School of Tropical Medicine, Kolkata
108, Chittaranjan Avenue
Kolkata
WEST BENGAL
700073
India |
| Phone |
9674443064 |
| Fax |
|
| Email |
drdipans@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shatavisa Mukherjee |
| Designation |
Doctoral Scholar |
| Affiliation |
School of Tropical Medicine, Kolkata |
| Address |
Dept of Pharmacology,
School of Tropical Medicine, Kolkata
108, Chittaranjan Avenue
Kolkata
WEST BENGAL
700073
India |
| Phone |
9830529192 |
| Fax |
|
| Email |
shatavisa100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shatavisa Mukherjee |
| Designation |
Senior Research Officer |
| Affiliation |
School of Tropical Medicine, Kolkata |
| Address |
Dept of Pharmacology,
School of Tropical Medicine, Kolkata
108, Chittaranjan Avenue
WEST BENGAL
700073
India |
| Phone |
9830529192 |
| Fax |
|
| Email |
shatavisa100@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Tropical Medicine, Kolkata
108, Chitta Ranjan Avenue
Kolkata - 700034
West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Dipan Saha |
School of Tropical Medicine, Kolkata |
Room no 2; Diabetes Out Patient Clinic,
School of Tropical Medicine, Kolkata
108, Chittaranjan Avenue,
Kolkata - 700073
Kolkata
WEST BENGAL |
9674443064
drdipans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee, School of Tropical Medicine, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Diary Based Method |
Medication adherence is assessed by asking patients to manually record each dose taken in a paper or self-reported diary over a defined period. Duration of intervention will be 24 weeks. |
| Intervention |
Medisafe Mobile Application |
A smartphone-based platform designed to support patients in managing their medication schedules through features like timely reminders, dose tracking, adherence reports, and educational alerts. Duration of intervention will be 24 weeks. |
| Comparator Agent |
Verbal Adherence Instruction |
Medication adherence is promoted through direct, face-to-face counseling where healthcare providers verbally explain dosing schedules and importance of compliance. Duration of intervention will be 24 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18–70 years with type 2 diabetes mellitus
On stable oral hypoglycemic agents ± insulin for at least 3 months
Owns a smartphone (for Medisafe arm)
Provides informed consent. |
|
| ExclusionCriteria |
| Details |
Cognitive impairment or psychiatric illness interfering with adherence.
Severe diabetic complications (e.g., end-stage renal disease, advanced retinopathy).
Participation in another adherence-related trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Medication adherence measured using:
MARS Medication Adherence Scale (MARS 5) at baseline and 24 week
Pill count method at each follow-up visit.
|
Baseline and 24 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in HbA1c at baseline and at the end of 12 weeks and 24 weeks
Fasting and postprandial blood glucose values.
Renal parameters like blood urea, serum creatinine and spot urine albumin creatinine ratio were reassessed after 12 and 24 weeks and compared with the baseline values
Patient satisfaction and ease-of-use (Likert scale questionnaire).
|
12 weeks and 24 Weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/01/2026 |
| 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
|
With the increasing integration of technology into
healthcare, mobile health applications have emerged as innovative tools to
improve adherence. The Medisafe app is a smartphone-based platform designed to
support patients in managing their medication schedules through features like
timely reminders, dose tracking, adherence reports, and educational alerts.
These functionalities not only facilitate consistent medication intake but also
actively engage patients in their own care, potentially leading to better
clinical outcomes.
Comparing digital adherence tools like the Medisafe
app with conventional diary-based methods can provide valuable insights into
the relative effectiveness, patient acceptability, and practicality of these
approaches. Such comparisons are especially relevant in the context of chronic
disease management, where sustained adherence is essential for long-term health
benefits. Understanding which method promotes higher adherence can guide
clinicians, patients, and healthcare systems in adopting strategies that optimize
treatment outcomes. |