| CTRI Number |
CTRI/2025/02/081116 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of mobile application for lifestyle modification among patients following heart attack |
|
Scientific Title of Study
|
Effectiveness of App based lifestyle modification on metabolic profile ,self care compliance and quality of life of patients following Percutaneous coronary intervention - A randomized clinical 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 |
Madhavi S |
| Designation |
Professor cum Principal |
| Affiliation |
KMCH College of Nursing |
| Address |
259 Kalapatti post
COIMBATORE North
COIMBATORE
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9444150993 |
| Fax |
0000 |
| Email |
drsmadhavi@kmchcon.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhavi S |
| Designation |
Professor cum Principal |
| Affiliation |
KMCH College of Nursing |
| Address |
259 Kalapatti Post
Coimbatore North
COIMBATORE
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9444150993 |
| Fax |
0000 |
| Email |
drsmadhavi@kmchcon.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Madhavi S |
| Designation |
Professor cum Principal |
| Affiliation |
KMCH College of Nursing |
| Address |
259 KalapattiPost
Coimbatore North
COIMBATORE
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9444150993 |
| Fax |
0000 |
| Email |
drsmadhavi@kmchcon.ac.in |
|
|
Source of Monetary or Material Support
|
| The TN DR MGR Medical University
No 69 Annasalai Guindy Chennai
600032 |
|
|
Primary Sponsor
|
| Name |
The TamilNadu DR MGR Medical University |
| Address |
69 Annasalai Guindy Chennai 600032 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Thavamani D Palaniswami |
Managing Trustee
KMCH College of Nursing
Coimbatore641048 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Madhavi |
Kovai Medical Center and Hospital |
Department of Cardiology
Cardiac words IV floor
Post Box3209 Avinashi Road
Coimbatore641014
Coimbatore
TAMIL NADU |
9444150993
0000
drsmadhavi@kmchcon.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kovai Medical center and Hospital Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile app based Life style modification intervention |
The IND HEART SURAKSHA APP is a new mobile application developed by the investigators. After refinement of content and testing, ensuring the ease of use and adoptability the app will be uploaded in the post PCI patients mobile from android play store. The app will be designed with appropriate data protection measures. It will enable the researchers to monitor the self-care behaviors. Mobile based app Intervention will be given for three months. Participants will be followed up for six months and 1year |
| Comparator Agent |
Standard Care |
Both the group participants will receive the standard care
Usual discharge advice by the Nurses and Doctors
Computer assisted Education & Pamphlet
Medication advice
Telephonic follow up for the first four weeks once a week
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
1. Adult patients and above both male and female patients who are subjected to PCI .
2. Patients in the age group of 30 years too 70 years
3. Patients who are confident and willing to use android mobile
4. Literate patients who can read and write English or Tamil
5. Patients with or without diabetes and /or hypertension
6. Patients who has undergone PCI on elective or emergency basis
7. Irrespective of the number and type of stents
|
|
| ExclusionCriteria |
| Details |
1. PCI Patients with Stroke / Bronchial Asthma
2. Patients with who had earlier CABG
3. Patients with severe LV dysfunction (EF
less than 30%
4. Patients with cognitive or major physical dysfunction
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Self care compliances - Medication adherence, self care practices such as Physical activity dietary compliances, sleep patterns, stress reduction measures smoking cessation and alcohol consumption assessed through the self care compliance questionnaire
• 2 .Objective measure of self care compliance to physical activity - 6 minutes walk test
• Metabolic profile – Fasting blood sugar, fasting cholesterol, HDL, LDL and triglycerides, Waist hip ratio measurement ,BP
• Log of pain and other distressing symptoms
|
Self care compliances - Medication adherence, self care practices such as Physical activity dietary compliances, sleep patterns, stress reduction measures smoking cessation and alcohol consumption assessed through the self care compliance questionnaire
• 2 .Objective measure of self care compliance to physical activity - 6 minutes walk test
• Metabolic profile – Fasting blood sugar, fasting cholesterol, HDL, LDL and triglycerides, Waist hip ratio measurement ,BP
• Log of pain and other distressing symptoms
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life |
Baseline - 3 days after PCI
Post test- 1 year after PCI |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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 1 |
|
Date of First Enrollment (India)
|
27/03/2025 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Objectives of the study are 1. To develop the IND HEART SURAKSHA app based on the need assessment from patients, their families and experts. 2. To evaluate the effectiveness of the mobile app based lifestyle modification on self-care compliance, metabolic profile and quality of life. Hypothesis There will be significant difference in self care compliance ,metabolic profile and quality of life of the standard care group and the m.app based life style modification group at p<0.05 level . Intervention The newly developed and refined IND HEART SURAKSHA APP will be made available to the individual participant in the experimental arm from play store. The participants will be educated about the features of the app and demonstrated on its use while they are in the wards . Both the group participants will receive standard computer based education on the nature of CAD, PCI and required lifestyle modifications after PCI while they are in the cardiac wards but before discharge to home . They will also be supplemented with carry home instructions on home care and follow up. Regarding the medication timing ,dosages standard individualized instruction by the ward nurses will be carried out for both the groups .Both group of patients will be followed up telephonically in the first four weeks as part of routine transitional care Plan for Data collection Procedure After obtaining the informed consent ,background information will be obtained by individualized interview . Their clinical information regarding the PCI procedures will be extracted from the case sheets .The Biochemical parameters obtained also will be collected from the case sheet . Premorbid self care behaviors and Quality of life will be obtained using Self care questionaire and RAND SF 36 questionnaire respectively . One month later both the groups will be contacted when they come for follow up . They will be requested to complete the self care behavior questionnaire . Post test 2 and 3 will be completed by both the groups using the same techniques and questionnaire at 6 months and 12 months post PCI. Fasting biochemical parameters will be checked at 6 months and 12 moths post PCI Their physiological parameters such as weight, BP, Pulse , waist hip circumferences, 6 minutes walk test will be obtained by the investigators at baseline 1month, 6montha and 12 months post PCI . |