| CTRI Number |
CTRI/2024/12/077853 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship of depression, anxiety, stress, and social support with lifestyle practices and taking the prescribed medication among the heart attack survivors. |
|
Scientific Title of Study
|
Psychosocial responses to illness and its relationship with lifestyle practices and medication adherence among myocardial infarction survivors in a selected hospital, Kolkata |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nabanita Sahu |
| Designation |
PhD Nursing Student |
| Affiliation |
College and School of Nursing R. N. Tagore Hospital, a Unit of Asia Heart Foundation |
| Address |
College and School of Nursing R. N. Tagore Hospital, a Unit of Asia Heart Foundation,
Department- Nursing,
Room no. 1,
Ukhila-2, Paikpara road, Narendrapur
Kolkata
WEST BENGAL
700103
India |
| Phone |
8240162163 |
| Fax |
|
| Email |
niki.sahu97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Kasturi Mandal |
| Designation |
Professor cum Principal |
| Affiliation |
College and School of Nursing R. N. Tagore Hospital, a Unit of Asia Heart Foundation |
| Address |
College and School of Nursing R. N. Tagore Hospital, a Unit of Asia Heart Foundation,
Department- Nursing
Room no. 1
Ukhila-2, Paikpara road, Narendrapur
Kolkata
WEST BENGAL
700103
India |
| Phone |
7980757597 |
| Fax |
|
| Email |
mandalkasturi.study@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nabanita Sahu |
| Designation |
PhD Nursing Student |
| Affiliation |
College and School of Nursing R. N. Tagore Hospital, a Unit of Asia Heart Foundation |
| Address |
College and School of Nursing R. N. Tagore Hospital, a Unit of Asia Heart Foundation,
Department-Nursing,
Room no. 1,
Ukhila-2, Paikpara road, Narendrapur
Kolkata
WEST BENGAL
700103
India |
| Phone |
8240162163 |
| Fax |
|
| Email |
niki.sahu97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nabanita Sahu (Self)
College and School of Nursing R. N. Tagore Hospital, a Unit of Asia Heart Foundation,
Department- Nursing
Room no. 1
Ukhila-2, Paikpara road, Narendrapur, Kolkata-103, India |
|
|
Primary Sponsor
|
| Name |
Nabanita Sahu (self) |
| Address |
College and School of Nursing R. N. Tagore Hospital, a Unit of Asia Heart Foundation, Ukhila-2, Paikpara road, Narendra, Kolkata - 103 |
| Type of Sponsor |
Other [PhD student] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nabanita Sahu |
Medical College Kolkata |
Cardiology Department, Room no. 3, 88 College Street, Kolkata 700073, India
Kolkata
WEST BENGAL |
8240162163
niki.sahu97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Medical College Kolkata |
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 |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with myocardial infarction admitted in hospital and attending cardiology OPD.
2. Myocardial infarction survivors willing to give consent to participate in the study.
3. Patients with myocardial infarction admitted in hospital and attending cardiology OPD during the period of data collection.
4. Patients who understand and speak Bengali language
|
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed with myocardial infarction with age below 30 years.
2. Clinically unstable patients with myocardial infarction.
3. Unconscious patients with myocardial infarction.
4. Patients who didn’t survive after initial treatment of myocardial infarction
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Psychosocial responses to illness in terms of depression, anxiety, stress and perceived social support among the myocardial infarction survivors.
2) Lifestyle practices among myocardial infarction survivors.
3) Medication adherence among myocardial infarction survivors. |
Baseline on discharge of the patient from hospital followed by 1st, 2nd and 3rd month of OPD visit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="421"
Sample Size from India="421"
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)
|
26/12/2024 |
| 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="5"
Months="0"
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
|
This is a single centre, longitudinal study that will be conducted among the patients diagnosed with myocardial infarction to assess their psychosocial responses to illness and its relationship with lifestyle practices and medication adherence. Psychosocial response to illness will be assessed during hospital stay of the myocardial infarction survivors. Lifestyle practices and medication adherence will be assessed at first, second and third month of the OPD visit of the patient after discharge from hospital. A total of 421 study participants will be included in the study as per the inclusion and exclusion criteria. |