Prof.Praveena K.R PhD Scholar Yenepoya University

1. “A PHENOMENOLOGICAL STUDY ON THE LIVED EXPERIENCES OF WOMEN WITH ISCHEMIC HEART DISEASE IN CALICUT, KERALA” Co- Investigators Principal Investigator Dr.Asha P Shetty, Dean, Yenepoya Nursing College Dr. M.N Krishnan, Consultant Cardiologist, Malabar Medical College, Calicut Prof.Praveena K.R PhD Scholar Yenepoya University

2. Introduction &Background • Ischemic heart disease (IHD) is one of the leading causes of death and disability among young and older women, respectively 1, 2 • IHD includes of Myocardial Infraction (MI, Heart attack) and Angina pectoris

3. Introduction contd.. • IHD is caused by inadequate blood supply to the muscles of the heart 3 • The purpose of this study is to understand what sense or meaning people make of their experience of IHD treated in an acute healthcare facility

4. Introduction contd.. • It is not surprising to know people lack awareness of the consequence of this dreadful disease even after primary exposure of a cardiac event. • This insight call for new, expanded, and fresh ways to deliver information and • provide resources to support IHD patients while they are in an acute healthcare facility.

5. Literature Survey • IHD has been regarded as a global burden from early nineties. • Though medical technology has advanced drastically over the past decade, • the morbidity and mortality associated with heart diseases are still on the higher side (6-8). • In United States, one in every seven death in the year 2011 was associated with Coronary heart disease and • about 375,295 Americans were died with this disease

6. Literature Survey contd.. • It is estimated that in each year there will be about 635,000 newly diagnosed cases of Coronary attack and • about 300,000 cases of recurrence. • About every 34 seconds one American is affected with coronary events and dies in every 1 minute 34 seconds (9). • In India, it is the first among the five top causes of death.

7. Literature Survey contd.. • In 2000, out of 1.03 billion people, about 29.8 million were affected with CHD with a prevalence rate of 3 % (10.11). • There were regional variations also found with an overall prevalence of 11% • while age standardized prevalence computed was only 9% which is a 10 fold increase during last 40 years in Urban India.

8. Literature Survey contd.. • Trend analysis indicates that almost 70% of world’s IHD population lives in India by 2010. • The forecast also postulates that from the year 2000 to 2020, • the affected age group between20-29 will double while females also will keep up the pace (12).

9. Literature Survey contd.. • A population based study was conducted to assess the lifestyle factors, medication use and risk of IHD. • Cohorts of 14890 patients above 40 years of age were taken from Western Australia. • The results revealed lifestyle factors has a significant role in the reduction of IHD risk • in spite of the control with antihypertensive and lipid lowering medications (13).

10. Literature Survey contd.. • Another survey was conducted among patients between 35 to 74 years old • to assess the trends in the incidence of Myocardial infarction and mortality due to IHD and • the results revealed that though there was an increase in the number of cases, the mortality associated with IHD has significantly reduced (14).

11. Literature Survey contd.. • A study was conducted to identify the impact of socio economic status on IHD morbidity and mortality among diabetic and nondiabetic patients in Finland. • Among diabetic people, there were higher incidence of IHD and sudden cardiac death. • However, there is no significant difference found in long term prognosis (15)

12. Literature Survey contd.. • In a study to identify the predictors and outcome of patients with Non ST segment elevated Myocardial Infarction (NSTEMI) and associated CAD • revealed that almost 9% of patients with NSTEMI had developed insignificant CAD and • female sex and younger age were identified to be the strongest predictor (16) .

13. Literature Survey contd.. • A survey was conducted in Spain to determine the incidence, prevalence and coronary heart disease risk in patients with Type 2 (non-insulin dependent) diabetes mellitus. • The study was conducted with a sample size of 65651 and samples were older than 24 years of age. • The results showed that these patients with type 2 diabetes have a higher risk of development of CAD (17).

14. Relevance of the study contd.. • Knowing that the function of heart, as the core of life, being disturbed is probably the most threatening experience for people with heart attack • It is evident that patients have a vague perspective of their life after having heart attack 6 • The care given to women with IHD needs to be based on deeper description of their experiences

15. Relevance of the study • Patients with IHD are generally admitted to critical care unit (CCU). • Their health care mostly focuses on physiotherapy, pharmacology, and their biological response. • Little attention is thus paid to psychological support of patients 4 • Heart attack and acute Angina Pectoris remarkably affect quality of life of patients and their families and depict a major crisis in their life 5.

16. Relevance of the study contd.. • Women’s experience of IHD during hospitalization is an important field of study in nursing 7 • Nurses are the main part of healthcare system who spend more time with patients affected with IHD and • So have a unique opportunity to help them to overcome their problems

17. Relevance of the study contd.. • Nurses and other health care providers want to perceive the experiences of their patients, enter their world, and realize the social processes that clarify disease and health events 8. • Therefore, it is necessary to focus to experiences of patients in order to propose effective solutions.

18. Aim • This study aimed to describe lived experience of women with IHD to provide a suitable guide for nursing practice.

19. Objectives • Describe the understanding and meaning-making among women with IHD during hospitalization • Examine the experiences of women with IHD after returning home • Explore the support needs of women while living with chronic illness • Analyze the challenges of women reported upon returning home following IHD

20. Methodology • Source of Data • Date will be collected from women diagnosed with IHD in selected hospitals of Calicut District. • Research Approach & Design • Qualitative descriptive phenomenological research will be conducted on women admitted to CCU and post -CCU wards due to IHD or those who are attending Cardiology clinics.

21. Methodology contd.. • Study Setting • The settings of the study are selected hospitals in Calicut District. • Population • Women diagnosed with IHD in selected hospitals in Calicut District

22. Methodology contd.. • Sample and Sampling Technique • All female patients of age group between 35 to 60 years who fulfill the inclusion criteria are considered as sample. • Purposive sampling will be adopted for female patients who had experienced IHD and were willing to participate in the study. • In a qualitative study, sampling continues until data saturation occurs.

23. Methodology contd.. • Inclusion Criteria • Women with IHD who are willing to participate in the study. • Women with IHD between35-60years of age group • Exclusion Criteria • Patients who are not available during the period of data collection

24. Methodology contd.. • 1. An Interview guide will be prepared which consists two sections. • Section A:It consists of demographic variables of participants • Section B:Interview guide; It includes a combination of open-ended descriptive questions that encourage thoughtful responses to assess the lived experience of women with IHD. • 2. Recording Device

25. Methodology contd.. • Rigor of the study is recommended by Polit and Beck in four aspects of credibility, dependability, confirmability and transferability. • Credibility of the study will be ensured by long and deep engagement of the researchers in data collection and analysis, • Using parallel analyses of several interviews by other researchers and comparing their results with those of the researchers, and also by returning the results to the participants for revision.

26. Methodology contd.. • Dependability and confirmability can be checked by an audit trial. • Two of the tapes along with the tapescripts may be given to a qualitative study expert who did not take part in the study for analysis. • Transferability will be maintained by diversifying participants and describing the findings and all procedures in detail.

27. Research / study plan

28. Methods of Data Collection • Deep and semi-structured interviews will be used to collect data. • During meeting with the participants, the nature, objectives, and method of the study and their role will be explained. • Informed consent from participants for recording the interview will be obtained. • The interviews will be transcribed word by word and then check with the recorded information again.

29. Format of informed consent • APPENDIX B – Research Participant Information & Consent Form • Title of study: A phenomenological study on the lived experiences of women with Ischemic heart disease in Calicut, Kerala • Name of the Principle Investigator: Prof.Praveena K R, PhD Scholar, Yenepoya University, Mangalore • Name of the Guide : Dr Asha P Shetty, Dean, Yenepoya Nursing College, Mangalore • Name of the Co Guide: Dr.M.N.Krishnan, Consultant Cardiologist, Malabar Medical College, Calicut • NAME OF PARTICIPANT:_______________________________________ • Key Identifier number:____________________________________________ • PURPOSE OF THE STUDY • The purpose of this research study is to help healthcare providers understand the experiences of women who have suffered Ischemic heart disease (IHD). This will be done by using your description of the experience obtained through a conversation with the Principle Investigator. • HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? • Up to 12 people will be interviewed for this study. • WHAT DOES THE STUDY INVOLVE? • If you agree to take part in this study by signing this informed consent form, the Principle Investigator, Prof.Praveena K R will contact you by telephone to confirm the best time and location that works for you, to meet for an interview conversation. The estimated time for the interview is 2 hours, however, may not take a full 2 hours. The purpose of the interview is for you to tell your story and describe your experience of Living with IHD. • The interview will be audio-taped so that the Principle Investigator can replay the interview as much as needed when putting together what is learned from all of the other interviews. The audio-tape will be de-identified by attaching a pseudonym name. The pseudonym name will be linked to your informed consent by a key identifying number. The audio-tape will then transcribe as verbatim. Once

30. Format of informed consent contd.. • the audio-tape has been transcribed it will be erased. The Principle Investigator will ask your permission to make one follow-up telephone call to you, in order to ask for any further information and that you have read your transcript to verify with you that is what you said. • HOW LONG WILL I BE IN THE STUDY? • The interview will take up to 120 minutes or 2 hours. The follow-up phone call should take no longer than 30 minutes. Therefore, the total time involved in participation will be 2 and ½ hours. • WHAT ARE THE RISKS OF THE STUDY? • As someone who has experienced a heart disease, it may be possible that you may experience some emotional or psychological discomfort as you remember the journey you have been on since your experience. You can take all the time and / or space you need during the conversation. You may have a break at any time during the conversation. • WHAT ARE THE BENEFITS TO TAKING PART IN THIS STUDY? • Your participation in this research may be beneficial to you and other people who have IHD. It is well documented that people who tell their stories and describe how difficult life experiences have changed them to varying degrees, experience the following benefits: (1) clearer self-understanding and personal meaning-making of their experience, (2) the satisfaction of sharing one’s story with others, (3) the experience of disclosure that is essential to healing from difficult experiences, (4) the opportunity to share personal stories and life experience more broadly so that others can learn and understand different people and experiences, (5) the opportunity to validate one’s experience and show the commonality in human experience. • WILL MY TAKING PART IN THIS STUDY BE KEPT CONFIDENTIAL? • Your confidentiality will be respected. You will be assigned a pseudonym name and key identifier number as a participant in this study. The pseudonym name and key identifier number will be used on any research-related information collected about you during this study so that your identity will be kept confidential. • Research records identifying you may be inspected in the presence of the Principle Investigator or her designate for the purpose of monitoring the research. These personnel are required to keep your identity and personal information confidential. Your consent to participate in this study provides permission for the researcher, supervising faculty, and dissertation committee members who may need to see your de-identified interview transcript for analysis purposes. The findings of this research will be published in the form of a dissertation and presented to research conferences. It may be

31. Format of informed consent contd.. • will be published in the form of a dissertation and presented to research conferences. It may be published in journals, books, presentations and reports to decision makers in healthcare. What will be reported is where the study took place (i.e. India, Kerala and Calicut). The data obtained from this research study may be used for secondary analysis at some point in the future. This means that the data may be used to answer another question. Ethical approval will be obtained from the Institutional Review board. No information that discloses your identity will be released or published. • All hard copies will be kept within a locked filling cabinet in the principle investigator’s work office and destroyed after 5 years. • YOUR PARTICIPATION IS VOLUNTARY • Your participation is entirely voluntary, and you are free to withdraw at any time. All of your information collected prior to your withdrawal may be removed at your request. If you do not wish to participate, or if you withdraw from participation, you do not have to provide any reason for your decision. You will not lose the benefit of any medical care to which you are entitled or are presently receiving. • REMUNERATION • There will be no remuneration for participating in this study. • WHAT DO I DO IF I HAVE QUESTIONS AND CONCERNS ABOUT THE STUDY? • If you have any questions or desire further information about this study you can contact Prof.Praveena K R, at 09544740811 or via email at veenakr2011@gmail.com • CONSENT TO PARTICIPATE • Your signature below indicates that you have received a copy of this consent form for your own records and that you consent to participate in this study. • 1. Participant Signature:___________________________________________ • Date:______________________________________________________ • Printed Name of the Participant Signing Above: • Phone:_______________________________________________________ • 2. Witness Signature:____________________________________________

32. Format of informed consent contd.. • Date:_______________________________________________________ • Printed Name of the Participant Signing Above: • ____________________________________________________________ • 3. Would you like to receive a summary of this study? • □ Yes □ No • If yes, please provide mailing Aadress: • 4. Would you like to be contacted about participation in future studies? • □ Yes □ No

33. Performa for Data Collection • APPENDIX C - Demographic Data • Name of the Participant_______________________________________________ • Date of Birth : • Ethnicity : • Marital Status : • Number of years married : • Income/month : • Work outside the home : • When diagnoses with heart disease first made : • How IHD disease treated medically and/or surgically : ------------ • Is there any additional treatment for IHD after initial diagnoses? : ------------ • If yes, Type of treatment : -------------

34. Performa for Data Collection contd.. • APPENDIX D- Interview Guide • This interview process will be based on a combination of a “conversation with a purpose” to facilitate an interaction that supports participants to tell their story in their own words (Smith, Flowers & Larkin, 2008, p. 57) with the “goal of generating a detailed account rather than brief answers to general statements” (Reismann, 2008, p. 23).. • Interview based on this approach is to facilitate and open space for conversation like atmosphere that allows participants to narrate their story. This requires the interviewer to listen well, flexible and responsive to where the participant wants to go with their story and express genuine interest and appreciation of the stories that are shared. • The interview guide below is simply a guide for the story. In includes a combination of open-ended descriptive questions that encourage thoughtful responses. • Opening question: •  Tell me about your experience of affected with heart disease •  How did your symptoms start? •  What were you thinking at the time? •  Tell me about your experience in the hospital? •  Tell me about your experience after you arrived home from the hospital? •  What supports in the home did you find helpful or not helpful? •  What did the experience of affected with IHD mean to you? •  What impact(s) has your disease had in your family life/social life? •  What lifestyle changes have you made (if any)? • During interview, open-ended probes are used to have deeper understanding of the areas / statements of interest, such as: •  Why? •  Why did you come to that conclusion? •  I am not sure I understand, can you tell me more about that? •  How did that feel to you / how did that make you feel? •  What was that experience like for you? •  What did that mean to you / what do you mean by that?

35. Performa for Data Collection contd.. • How did you manage to get through that? •  What happened next / what did you do next? •  What is different for you now? • Close •  Is there anything else you would want to tell me about how your experience has impacted your development and who you are now? •  What are your feelings about this interview? •  Do you have any questions for me?

36. Performa for Data Collection contd.. • Appendix E - Evaluation and Interview Close What, if anything, have you found most helpful/ beneficial about sharing your story in this 3 interview and why? • I consent to have you contact me to further clarify any part of my story or to ask me for additional information. • □ Yes □ No • I am interested in being part of further studies related to this one or to be part of other 13 research. 14 • □ Yes □ No • Please Note: • I will store this document separately from your informed consent form in my paper files to protect your confidentiality. Your transcribed story may be slightly edited to ensure flow through the entire dissertation. In addition, I will be interpreting your story along with others I will hear through my interviews for my final dissertation. Therefore, the final dissertation, you may only find summaries, excerpts, quotes or composites of your story weaved with similar ones. In essence, my final dissertation and any related publications will have threads of your storied experience and will be interpreted with others to arrive at the overall story of what I will learn. My overall intent will be to honour each story and participant voice as a whole as much as possible. I will send you a summary of the findings as agreed. • Date:_____________________________________ • Signature:__________________________________

37. Statistical Analysis • Colaizzi’s phenomenological method will be used to analyze data. • The tapescripts will be studied and revised meticulously and statements related to the phenomena will be extracted in order to understand the feelings of participants. • Then, codes will be organized in categories which are confirmed by participants.

38. In the next stage, the results will be integrated using a complete description of the studied phenomenon and revised to have clear concepts. • The final results will be returned to the participants to be validated.

39. A summary of Colaizzi's strategy for Phenomenological data analysis

40. COST ESTIMATION

41. COST ESTIMATION contd..

42. Time Schedule of Activities

43. Requirements • Ethical Clearance Certificate • Validation of tool • Equipments needed : Nil • Consumables: Papers, Stationeries, Recording device

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