| CTRI Number |
CTRI/2025/04/084053 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [smartphone application] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Mobile App for CAD patients to assess the effect on medication adherence, diet compliance. physical activity and self care |
|
Scientific Title of Study
|
A Randomized controlled trial to assess the effectiveness of smartphone application Mediac on medication adherence, diet compliance, physical activity and self- care among CAD patients in Cardiology, AIIMS, New Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neeraj |
| Designation |
Student |
| Affiliation |
AIIMS |
| Address |
Porta Cabin 2, College of Nursing, AIIMS, New Delhi -110029
New Delhi
DELHI
110029
India |
| Phone |
07838503927 |
| Fax |
|
| Email |
dahiyan100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Smita Das |
| Designation |
Associate Professor |
| Affiliation |
AIIMS |
| Address |
Room No. 2, College of Nursing, AIIMS, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
09871755975 |
| Fax |
|
| Email |
smitadas307@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeraj |
| Designation |
Student |
| Affiliation |
AIIMS |
| Address |
Porta Cabin 2, College of Nursing, AIIMS, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
07838503927 |
| Fax |
|
| Email |
dahiyan100@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Neeraj |
| Address |
Porta Cabin 2, College of Nursing, AIIMS, Ansari Nagar East, New Delhi -110029 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Neeraj |
AIIMS |
Room No. 15, Cardiology OPD, AIIMS, Ansari Nagar East, New Delhi- 110029
New Delhi
DELHI |
7838503927
dahiyan100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post graduate Research, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mediac Smartphone Application |
The app is a comprehensive health management tool designed by the researcher specifically for patients with coronary artery disease (CAD), offering an integrated approach to medication adherence, dietary compliance, physical activity, and self-care. It features customizable medication reminders, a list of heart-healthy foods, and physical activity plans to support cardiovascular health.
Users can enter and track vital signs such as Blood Pressure, Heart Rate, and Blood Sugar, etc. with trend visualizations. Stress management with relaxation exercises promote holistic well-being, while goal-setting and progress tracking keep users motivated. The app empowers users to take control of their heart health and achieve lasting lifestyle changes.
The components of the app are:
1. Medication reminders
2. Heart healthy diet recommendations
3. Physical Activities
4. Blood Pressure
5. Heart Rate
6. Blood Glucose
7. Weight, BMI
8. Symptoms
9. Library of files
10. OPD Schedule and Follow up
11. About CAD
It emphasizes the importance of customizable medication reminders, dosage instructions, and adherence tracking. Dietary recommendations are based on guidelines, encouraging balanced caloric intake, nutrient-dense foods, limited unhealthy fats, reduced sodium and sugar intake, increased fiber, and the inclusion of plant-based proteins. Physical activity guidelines stress gradual progression, warm-up and cool-down routines, and safe exercises like walking, cycling, yoga, and deep breathing, along with special precautions to avoid overexertion. Additionally, the plan includes tools for tracking vital parameters such as blood pressure, heart rate, blood glucose, weight, and symptoms. It also facilitates organizing medical records and setting reminders for OPD follow-ups, aiming to promote overall heart health, improve treatment adherence, and enhance quality of life.
|
| Comparator Agent |
Standard care |
Health teaching regarding their illness, importance of medication adherence, healthy diet, physical activity and measures to take care for themselves by monitoring their BP daily, coming for regular follow ups. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
able to read and understand hindi or english
willing to participate in the study
NYHA Class 2 or 3
owns an android smartphone and knows how to use it |
|
| ExclusionCriteria |
| Details |
recent CABG done in last 6 months
patients with orthopedic, neurologic, psychiatric, or cognitive disorders
patients with severe illnesses like CKD, CLD etc
NYHA Class 4
patients already using any other app with similar features |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.medication adherence
2.diet compliance
3.physical activity
4.self care |
At Baseline and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| system usability score |
3 months |
|
|
Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2025 |
| Date of Study Completion (India) |
12/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is crucial due to the high prevalence and impact of coronary artery disease (CAD). Effective management relies on holistic approaches, combining medication adherence, lifestyle changes, and self-care practices. Many patients struggle with adherence, leading to complications and higher healthcare costs. Many researches are there which support only around 50 % adherence to medications, and there is even less compliance with diet changes and physical activity. This research aims to provide robust evidence on the effectiveness of smartphone application “Mediac” interventions, improving outcomes, quality of life, and guiding personalized care plans. The app includes features like medication reminders, dietary recommendations, physical activity instructions and monitoring of symptoms in CAD patients. The findings can help patients manage their disease condition CAD in the long run with cost effective and efficient measures. |