TAMILNADU Chennai- 2 Through: – The ProperTAMILNADU Chennai- 2 Through: – The Proper

TAMILNADU
GOVERNMENT MULTI SUPER SPECIALITY HOSPITAL, CHENNAI 2

 

 

 

RESEARCH
PROPOSAL

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Effectiveness
of Community Based Cardiac Empowerment Package for Coronary Artery Disease Clients
on Lifestyle Modification, Self Care Management, Medication Adherence and QOL

 

 

 

SUBMITTED

 TO

INSTITUTIIONAL
ETHICAL COMMITTEE

TAMILNADU
GOVERNMENT MULTI SUPER SPECIALTY HOSPITAL, CHENNAI 2

 

 

PRESENTED
BY

MRS.
N. VANITHA, M.Sc. (Ng), M.A., M.B.A.

NURSING
TUTOR Gr.II

TAMILNADU
GOVERNMENT MULTI SUPER SPECIALTY HOSPITAL, CHENNAI – 2

 

 

 

 

 

FROM

            MS. N. VANITHA,

            Nursing Tutor Gr. II

            Tamil Nadu Government Multi Super
Specialty Hospital,

            Chennai- 2

To

            The Chairman,

            Intuitional Ethics Committee, (IEC),

            Tamil Nadu Government Multi Super
Specialty Hospital,

            Chennai- 2

 

Through:
– The Proper Channel.

 

Sub:
    Institutional Ethics Committee (IEC) –
Tamil Nadu Government Multi Super Specialty Hospital- approval for the study
titled “Effectiveness of Community Based Cardiac Empowerment Package for Coronary Artery Disease clients on
Lifestyle Modification, Self Care Management, Medication Adherence and QOL at

Sir,

As
I have proposed to conduct a study titled “Effectiveness of Community Based
Cardiac

Empowerment Package for Coronary Artery Disease Clients
on Lifestyle Modification,

Self Care Management, Medication Adherence and QOL.
A Randomized Control Trial at

 

I request for an approval from the Institutional
Ethics Committee, (IEC).

 I here with
enclosing the details of the project work.

 

 

 

 

 

 

I submit the following undertaking:

I will start the study after obtaining approval of
the Institutional Ethics Committee (IEC).

I will get informed consent from the patients and
maintain confidentiality of the details.

I will carry out the work without detrimental to
regular activities as well as without extra expenditure to the Institution or
the Government.

I will not deviate from the area of work for which I
have applied for ethical clearance.

I will inform the committee in the occurrence of any
adverse events or serious adverse reactions.

I will abide by the rules and regulations of the
institution.

I will complete the work within the specified period
I have applied for and if any extension of time is required, I shall apply for
permission again and continue the work.

I will submit the summary report/ report of the
study / project to the Institutional Ethics Committee.

I will not claim funds from the institution while
doing the work or on completion.

I understand that the members of the Institutional
Ethics Committee (IEC) have the right to monitor the study / project without
prior intimation.

I have paid a sum of Rs. 500 towards processing fee.

 

            Thanking
you

Chennai 2                                                                                            Yours
sincerely

 

 

 

 

 

 

 

GUIDE:

                    Dr. R. Shankar
Shanmugam.MSC.(N), MBA., PhD.,

                    Coordinator,

                    Nursing Education, PME &
Research Coordinator,

                    Tamil Nadu Government Multi Super Specialty Hospital,

                    Chennai – 2

 

Advisory
Committee Members

 

1.     
 Dr. G. Karthigeyan,

Senior Consultant & HOD,

Department of Cardiology,

Tamil Nadu Government Multi Super
Specialty Hospital,

Chennai – 2

 

2.     
     Dr. E. Prabhu, M.D, DRM, FRCP.,

    
Senior Consultant & HOD,

    
Department of Nuclear Medicine,

    
Tamil Nadu Government Multi Super Specialty Hospital,

    
Chennai – 2

 

 

 

 

 

 

 

 

 

 

,

 

 

 

 

 

 

 

 

RECOMMENDATION
OF THE HOD

 

The study titled
“Effectiveness of Community Based Cardiac
Empowerment Package for Coronary Artery Disease Clients on Lifestyle
Modification, Self Care Management, Medication Adherence and QOL. A randomized
control study at ——- according to the regulations of the Institutional
Ethics Committee and I recommend it for acceptance.

 

                                                                                                            —Sd—

                                                                       

 

                       

                            

 

 

 

 

 

 

 

 

 

REMARKS
OF THE GUIDE

 

This work undertaken /
to be done by Mrs. N. Vanitha titled “Effectiveness of Community Based Cardiac
Empowerment Package for Coronary Artery Disease Clients on Lifestyle Modification,
Self Care Management, Medication Adherence and QOL at, will be under my
supervision and I ensure that the candidate will abide by the rules of the
Institutional Ethics Committee.

                                                              
                                  —-Sd—–

Dr.
R. Shankar Shanmugam

 

 

 

 

 

 

 

 

 

 

DETAILS OF THE
PROJECT TO BE SUBMITTED BY

THE INDIVIDUAL
DESIROUS FOR CLEARANCE FROM

INSTITUTIONAL
ETHICAL COMMITTEE

 

 

SYNOPSIS /
SUMMARY

 

(This
is only a guideline – Relevant changes to be made as per the study
requirements)

 

 
 
Title

 
 

“Effectiveness
of Community Based Cardiac Empowerment Package for Coronary Artery Disease clients
on Lifestyle Modification, Self Care Management, Medication Adherence and QOL
at “.

Aims
 
 
 
 
 
 
 

1.     
Ascertain the unmet needs of the
clients after the Coronary
Artery Disease.
2.     
Analyze the psychosocial aspects such
as anxiety and depression among the clients after the Coronary Artery Disease.
3.     
Assess the physical activity, self care management and drug
adherence of clients with Coronary
Artery Disease
4.      Empower the clients
regarding self-care management techniques to prevent complications through
early identification and control of modifiable risk factors.
5.      Evaluate
the impact of Cardiac Empowerment Package on self-care of patients with Coronary Artery Disease.
6.       Provide knowledge, skills and increased
awareness about the disease.
7.      Facilitate
self-regulation to maximize patient’s capacity and ability.
8.      Recognize
their own health problems and take informed decisions for self management and
perform appropriate actions at home. 
 

Primary
Objectives
 
 
 
 
 

1.     
To
educate the clients to recognize their own health problems
2.     
To
provide knowledge, skills and increased awareness about the disease
3.     
To
facilitate self-regulation to maximize patient’s capacity and ability.
4.     
 To take informed decisions for managing appropriate
actions their own disease.
9.     
To
assess the impact of Cardiac Empowerment Package on self-care of patients
with Coronary Artery Disease
5.     
To correlate the findings with the demographic
variables.
 

Secondary
Objectives
 
 
 
 
 
 
 
 
 
 

 
1.     
To make the client functionally independent
2.     
To empower clients and caretakers regarding CAD
self-management techniques
3.     
To prevent relapse and to prevent complications
through early identification and interventions, and control of modifiable
risk factors.
4.     
To help the client to accept the limitations
imposed by illness
5.     
To lessen the exposure to the risk factors
6.     
To aid the client to adjust with the changes in
the occupation
7.     
To help the patients
regain autonomy and improve regular physical activities.
8.     
To help cardiovascular patients recover and optimize their
functional and mental status.

Study
Centre
 
 
 

Institute
of Advanced Research, Tamil Nadu Government Multi Super Specialty Hospital.

 
Duration
of the study
 

 
2
Years

Research
approach & study design

Experimental
– Randomized Control Trial

Methodology

 
(Material  & Methods )

Quantitative
study
 
Questionnaire
and observation method

Inclusion
criteria
 
 
 
 

1.     
Persons who had  Coronary Artery Disease
2.     
30 to 60 years old ( Both sex)
3.     
Able to read and write Tamil/English
4.     
willing to participate
5.     
the ability to
participate in the programs of empowerment
 

Exclusion
criteria
 
 
 
 

1.     
Not able to read or write Tamil/English
2.     
Not willing to participate
3.     
clients with psychiatric problems
4.     
clients more than 60 years
5.     
Clients with other complications
 

Sample
size

200

Product
/ Procedure / Investigation detail

·        
An informed consent will be obtained for the
clients who had Coronary Artery Disease.
·        
They will be assigned to Control and study group
randomly
·        
The both group will get CEP at 0 month where as
control group will get routine care 3rd and 6th month
·        
The study group will get telephone call
reinforcement once in 15 days and face to face program reinforcement at 3rd
and 6th month. Assessment will be done at the end of 3rd
and 6th month.

 
Data
collection and methods

·        
Selection of subjects ( Random sampling
·        
Assessment of Coronary Artery Disease clients Using
validated Questionnaire
 

 
Analysis
Plan

The
sample will be analyzed by following statistical methods:
Univariate
Bivariate
and
Multivariate
techniques

Sponsorship
(Yes / No
If
Yes Details

None

Conflicts
of Interest

None
 

 
 
Research
Scholar

MS. N.
VANITHA,
Nursing Tutor
Gr. II
Tamil Nadu
Government Multi Super Specialty Hospital,
Chennai- 2
 

 
 
Research
Guide

Dr.
R. Shankar Shanmugam.MSC.(N), MBA., PhD.,
Coordinator,
Nursing
Education & PME & Research Coordinator,
Tamil Nadu
Government Multi Super Specialty Hospital,
Chennai – 2