| CTRI Number |
CTRI/2024/04/066146 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Developing an mobile application to help remember taking medicine. |
|
Scientific Title of Study
|
Design and development of medication reminder application for improved medication adherence. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
I Steffi Lavinia |
| Designation |
Post Graduate |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Health Information Management, Manipal College of Health Professions, Manipal Academy of Higher Education.
Udupi
KARNATAKA
576104
India |
| Phone |
8121922151 |
| Fax |
|
| Email |
steffi.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Partha Protim Hazarika |
| Designation |
Associate Professor - Department of Health Information Management |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Health Information Management, Manipal College of Health Professions, Manipal Academy of Higher Education.
Udupi
KARNATAKA
576104
India |
| Phone |
8451012070 |
| Fax |
|
| Email |
partha.hazarika@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Reshmi |
| Designation |
Head of the Department of Health Information Management |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Health Information Management, Manipal College of Health Professions, Manipal Academy of Higher Education.
Udupi
KARNATAKA
576104
India |
| Phone |
9880530701 |
| Fax |
|
| Email |
reshmi.b@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Tiger Circle, Manipal, Udupi, Karnataka, Pin code - 576104, India |
|
|
Primary Sponsor
|
| Name |
Steffi Lavinia |
| Address |
Department of Health Information Management, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India. |
| Type of Sponsor |
Other [self-Steffi Lavinia] |
|
|
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 |
| Steffi Lavinia |
Kasturba Hospital |
Room no: 4, 2nd floor, Department of General Medicine, Unit-III, Smt. Sharada Madhav Pai OPD building, Kasturba Hospital, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
8121922151
steffi.mchpmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (2) ICD-10 Condition: N181||Chronic kidney disease, stage 1, (3) ICD-10 Condition: I10||Essential (primary) hypertension, (4) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Phase 1: Inclusion: Experts, Professors, Doctors
Professors, Associate Professors, and Senior Residents are included in the study.
Recruited from Kasturba Hospital – Medicine Department;
Phase 2: Inclusion - Doctors, Patients, Caregivers.
Recruited from Kasturba Hospital – Medicine Department Unit III.
|
|
| ExclusionCriteria |
| Details |
Phase 1: Exclusion – Patients and Caregivers
Phase 2:Exclusion - Patients and Caregivers who don’t have phones and are illiterate. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The app would make sure that it works well on all devices.
2. It helps to remember to take medicine as the doctor says.
3. Minimizing Drug Errors and Enhancing Safety.
4. Elevating Awareness and Knowledge |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
06/05/2024 |
| 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="3"
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
|
In Phase 1,
the application will be designed and developed using agile methodology, addressing
the limitations(research gap found during literature review) of already
existing mobile applications. Initial Testing of the developed application will
be conducted in the Department of Medicine at Kasturba Hospital. Participants
will be given a raw link to download the application on their phones for
testing purposes. The inclusion criteria for participants include Experts(Ex:
Unit Head), Professors(Ex: Professors, Associate Professors, Assistant
Professors), and Doctors (Ex: Senior Residents). They will assess the interface
design, ease of navigation, issues in the software if any, and overall performance
of the application. Subsequently, they will complete an online questionnaire to
validate the mobile application. The collected data will be reviewed and
analyzed, followed by necessary modifications will be done in the application.
This phase will be carried out for 3 months.
In Phase 2,
User Acceptance Testing will be conducted. Participants will include doctors (Professors,
Associate Professors, Senior Residents), patients, and caregivers selected from
both inpatient (IP) and outpatient (OP) of the Department of Medicine,
Unit-III. Similar to Phase 1, they will receive a raw link to download the
application on their phones. After downloading, they will test the functionality,
compatibility, performance, usability, and accessibility of the application.
Subsequently, they will complete an online questionnaire and the data collected
will be analyzed. Based on the feedback received the necessary modifications will
be carried out and this phase will take place for 2 months. |