| CTRI Number |
CTRI/2023/08/056063 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Physiotherapy (Not Including YOGA)
Other (Specify) [dietary] |
| Study Design |
Other |
|
Public Title of Study
|
Risk factors in heart attack |
|
Scientific Title of Study
|
A randomized control trial to assess the effectiveness of "m-Health Intervention Programme for lifestyle and risk factor modifications" on selected outcome variables among post myocardial young adults admitted in cardiology units of Advanced Cardiac Centre, PGIMER, Chandigarh. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumedha Sharma |
| Designation |
Student |
| Affiliation |
Post-graduate Institute of Medical Education and Research, Chandigarh |
| Address |
National Institute of Nursing Education, Post-graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7018799678 |
| Fax |
|
| Email |
sumedha1997sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monika dutta |
| Designation |
Associate professor |
| Affiliation |
National Institute of Nursing Education |
| Address |
National Institute of Nursing Education, Post-graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872528465 |
| Fax |
|
| Email |
monika.dutta75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika dutta |
| Designation |
Associate professor |
| Affiliation |
National Institute of Nursing Education |
| Address |
National Institute of Nursing Education, Post-graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872528465 |
| Fax |
|
| Email |
monika.dutta75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Post-graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Post-graduate Institute of Medical Education and Research, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rohit Manoj Kumar Ukadbhai |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Units of Advanced Cardiac Centre, Critical care unit, Cardiothoracic Unit A and B, Heart command, Cath lab
Chandigarh
CHANDIGARH |
9417001744
Cardiopgimerchd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of medical education and research Chandigarh institutional ethics committee |
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 |
m-Health Intervention Programme |
Hard and soft copy of written and AV material for imparting evidence- based information on myocardial infarction risk factors measures to be adopted for modifying risk factors importance of modification of risk factors and therapeutic compliance
Responding to patient queries through phone calls and text messages per week for 2 months on alternate days |
| Comparator Agent |
routine care |
Routine care will be provided to control group
heath teaching and medications will be administered on routine basis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
- Post myocardial infarction patients upto 40 years.
- Patients who can read and speak Hindi/English
- Willing to participate. |
|
| ExclusionCriteria |
| Details |
- Patients with mental health disorders
- Patients who do not have a smartphone with
internet facilities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reducing risk factors like smoking
alcohol
stress
dietary
medication adherence |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing readmission & complication |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
12/08/2023 |
| 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
|
I am assessing the effectiveness of "m-Health Intervention Programme for lifestyle and risk factor modification among post myocardial infarction patients. "m-Health interventions help to reduce the readmissions and complications. I am also screening the risk factors present in patient and help the patient to modify the risk factors. |