| CTRI Number |
CTRI/2017/10/010166 [Registered on: 23/10/2017] Trial Registered Prospectively |
| Last Modified On: |
25/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Use of mobile application] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Usage of Mobile Application to assist Patient Medication Taking Behavior in South Indian Diabetic Patients |
|
Scientific Title of Study
|
Implementation of a Customized Mobile Application to Improve Medication Adherence and Therapeutic Outcomes in Uncontrolled Diabetic Patients of Tamilnadu |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Ashok Kumar |
| Designation |
Associate Professor and Head |
| Affiliation |
Vels University |
| Address |
Department of Pharmacy Practice, School of Pharmaceutical Sciences, Vels University
Kancheepuram
TAMIL NADU
600117
India |
| Phone |
9884291144 |
| Fax |
|
| Email |
ashokpharma06.sps@velsuniv.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
M Ashok Kumar |
| Designation |
Associate Professor and Head |
| Affiliation |
Vels University |
| Address |
Department of Pharmacy Practice, School of Pharmaceutical Sciences, Vels University
Kancheepuram
TAMIL NADU
600117
India |
| Phone |
9884291144 |
| Fax |
|
| Email |
ashokpharma06.sps@velsuniv.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Anoosha Dasari |
| Designation |
Pharm D Intern |
| Affiliation |
Vels University |
| Address |
Department of Pharmacy Practice, School of Pharmaceutical Sciences, Vels University
Kancheepuram
TAMIL NADU
600117
India |
| Phone |
8056057792 |
| Fax |
|
| Email |
anooshadasari03@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Pharmaceutical Sciences
PV Vaithyalingam Road
Velan Nagar
Pallavaram
Chennai-600117 |
|
|
Primary Sponsor
|
| Name |
School of Pharmaceutical Sciences Vels University |
| Address |
PV Vaithyalingam Road, Velan Nagar, Pallavaram, Chennai-600117 |
| Type of Sponsor |
Other [Private Pharmacy College] |
|
|
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 |
| M Ashok Kumar |
Employees State Insurance Hospital |
Medical Ward (M1-M3), II Floor, ESIC Hospital
Medavakkam Tank Road, Ayanavaram, Chennai-600023
Kancheepuram
TAMIL NADU |
9894606049
ashokpharma06.sps@velsuniv.ac.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vels Institute of Science Technology and Advanced Studies (VISTAS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Uncontrolled Diabetic Patients with Poor Medication Adherence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Customized Mobile Application Usage |
Medication adherence and Blood Sugar Profile will be monitored in patients who use the mobile application besides receiving treatment with standard regimen. |
| Comparator Agent |
Standard Treatment alone |
Use of mobile application will be restricted in this arm. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with type II diabetes mellitus on medication with HbA1c greater than 8.0%, willing to provide a written informed consent and come for followup after one and third month. |
|
| ExclusionCriteria |
| Details |
Type II diabetic patients with HbA1c less than 8.0%
Patients with underlying psychiatric conditions that limit participation.
Patients with neurodegenerative diseases including Alzheimer, Parkinsonism and Senile dementia.
Patients without access to internet and android devices.
Patients who are not willing to provide written informed consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Mobile Application Implementation on Medication Adherence and Blood Sugar Profile. |
0, 1, 3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of factors influencing effective implementation of mobile application for enhancement of medication adherence. |
3rd month |
| Confounding effect of patient demographics and clinical variables on the mobile application mediated change in medication adherence and therapeutic outcomes. |
3rd month |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="690" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2017 |
| Date of Study Completion (India) |
13/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study aims to implement a effective customized mobile application for uncontrolled diabetic patients of Tamilnadu, India to enhance medication adherence and thereby improve therapeutic outcomes. The study protocol does not involve any major intervention or invasive procedure and possesses benefits to the target population. |