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1. Sympthom Burden and Health Related Quality of Life among Patients with Heart Failure in Indonesia Masroni Advisor: Prof. Hsing-Mei Chen PhD., RN International Advanced Program in Nursing, Department of Nursing College of Medicine, National Cheng Kung University, Tainan- Taiwan, R. O. C 1

2. Background (1/3) 2 T he prevalence will be increase d 46 % . TODAY HF incidence is the most common for emergency visits, hospitalization and re-hospitalization. Increasing the number of mortality. E stimated 0.13% or 229 , 696 people diagnosed with Heart Failure (Hwang, Liao, & Huang, 2014; Lee & Auld , 2015; Mulligan, 2012; Negarandeh , 2015). ( Go et al., 201 3 ). ( Ministry of Health Indonesia , 2014) Back Heart Failure

3. Background (2/3) Health-related quality of life ( Hr-QoL ) emphasizes the impact of disease on health status and is a multi-dimensional concept which comprises domains of physical, mental, emotional, and social functioning ( Ferrans , 2005). All of these concepts reflect issues that are of fundamental importance to a patient’s well-being ( Fayers & Machin, 2013). Many studies have been reported that patients with HF experienced poor quality of life (Comin et al., 2016; Cowie et al., 2002; Hwang, Liao, & Huang, 2014; Obieglo et al., 2016; Tatukude, Rampengan, & Panda, 2016). 3

4. Background (3/3) The prognosis of HF is poor in the first month due to numerous and severe symptom and great symptom burden (Cowie et al., 2002; Xu et al., 2015). Those who are living with HF experience significant symptom burden and poor quality of life ( Hwang, Liao, & Huang, 2014; Hu, Hu, Su, & Qu, 2016; Comin et al., 2016; Obiegło et al., 2016 ) Symptoms burden in patients with HF affect functional status, quality of life, physical activities of daily life, survival and economy outcomes ( Kutner , Kassner , & Nowels , 2001). 4

5. SIGNIFICANCE OF STUDY 5

6. Significance of Study ( 1 / 3 ) Research studies have examined symptom burden and Hr-QoL among patients with HF and found poor quality of life in developed countries and industrial countries ( Callender et al., 2014), there is still rare information regarding this area in developing countries such as Indonesia. Most of Indonesian people have low and middle-income level that can affect health care needs due to the fact that the cost of health care is high (V an Doorslaer et al., 2006). N umerous and severe symptoms resulted from poor disease management maybe are due to the rarely use health care facilities by the patients. Previous studies have found that financial status has shown an indirect effect on poor quality of life (Hu, Hu, Su & Qu, 2016; Iqbal et al., 2010). 6

7. Significance of Study ( 2 / 3 ) A systematic review studies found that religion plays an important role in public life due to having a beneficial impact on survival and health outcomes (Townsend, 2002). Another study states that religion has been evaluated and assumed to have a positive effect including global quality of life, depression and medical compliance in the treatment of patients with HF ( Naghi , Philip, Phan, Cleenewerck , & Schwarz, 2012 ). More than 80 % of the total population of Indonesia are Moslem, and r eligion may have an effect on Hr-QoL in Indonesia patients. 7

8. Significance of Study ( 3 / 3 ) Since factors related to Hr-QoL in Indonesian HF patients may be different from patients in other countries. And most previous studies conducting in this area using only one questionnaire to measure Hr-QoL of the patients. 8 There is a need to identify the determinants of Hr-QoL among patients with HF in Indonesia. Back

9. Research Purpose 9 T o determine the relationship between symptoms burden and Hr-QoL among patients with HF in Indonesia. Back

10. Literature Review 10

11. Literature Review: HF HF is abnormality of structural and/or functional cardiac to maintain a sufficient balance between fulfilling circulation and metabolic needs of the body, characterized by clinical syndrome with a typical sign ( Ponikowski et al., 201 6 ) . The main classification of according to American Heart Association (AHA) 2016 ( Ponikowski et al., 201 6 ) . Heart Failure with reduced Ejection Fraction (HFrEF) < 40 %. Heart Failure with mid-range Ejection Fraction (HFmrEF) 40-49%. Heart Failure with preserved Ejection Fraction (HFpEF) > 50%. 11

12. Literature Review: HF Symptoms 12 According ESC guidelines (2016), symptoms and sign of HF classified into four categories ( Ponikowski et al., 2016). typical (e.g. breathlessness, orthopnea, paroxysmal nocturnal dyspnea, reduced exercise tolerance, fatigue, tiredness, ankle swelling, increased time to recover after exercise). less typical (e.g nocturnal cough, wheezing, bloated feeling, loss of appetite, confusion (especially in the elderly), depression, palpitations, dizziness, syncope, bendopnea). more specific (e.g. elevated jugular venous pressure, third heart sound (gallop rhythm) and laterally displaced apical impulse). less specific (e.g. Tachycardia, irregular pulse, tachypnoea, cheyne stokes respiration, hepatomegaly, ascites, oliguria and narrow pulse pressure, weight gain (>2 kg/week), weight loss tissue wasting (cachexia) cardiac murmur, peripheral oedema (ankle, sacral, scrotal), pulmonary crepitations) SYMPTOM BURDEN SYMPTOM BURDEN SYMPTOM BURDEN

13. Literature Review: Symptom Burden Symptom burden is the subjective experience of the number and severity of the symptoms reported by patients with having a disease or treatment (Cleeland, 2007), including prevalence, frequency, severity and distress (Gapstur, 2007). HF is a chronic syndrome that can cause a variety of symptoms associated with multiple organ dysfunction s ( Fotos et al., 2013) and ha s greater symptom burden than many- other chronic disease s (Xu et al., 2015) and induces poor quality of life (Zambroski et al., 2005; Hwang, Liao, & Huang, 2014; Hu, Hu, Su, & Qu, 2016; Comin et al., 2016; Obiegło et al., 2016 ) 13

14. Literature Review: Factors Associated with Symptom Burden Marital status (Johansson, Dahlström & Broström, 2006). Gender (Steptoe, Mohabir, Mahon & McKenna, 2000; Zambroski et al., 2005; Johansson, Dahlström & Broström, 2006Xu et al., 2015). Age (Zambroski et al., 2005; Xu et al., 2015). 14 Demographic differences including religion, race and education may have a sampling bias. Need further research to examine the relationship between demographic variables and symptom burden. (Xu et al., 2015). (Xu et al., 2015).

15. Literature Review: QoL World Health Organization ( WHO ) defines QoL as perceptions of a patient’s life quality in the context of the culture and value system in their life related with insufficiency of physical, mental, and social lives (WHO, 1996). Hr-QoL represents the quality of life, result ing from a person's health status, and disease experience, which reflects the ability to function in daily life ( Kawecka-Jaszcz , Klocek , Tobiasz-Adamczyk , & Bulpitt , 2013). A concept of Hr-QoL commonly is used to focus on the effects of illness and treatment ( Lipscomb, Gotay & Snyder , 2004 ) . Perception of Hr-QoL reflects the patient's ability to function in life situation even in untreatable chronic diseases ( Kawecka-Jaszcz , Klocek , Tobiasz-Adamczyk , & Bulpitt , 2013) . 15

16. Literature Review: QoL in HF Hr-QoL is one of the common characteristics of patients with HF ( Hassanpour & Khaledi , 2015) . In the recent cross-sectional study by AbuRuz et al., (2016) of 103 patients with HF using a convenient sample reported poor in all domains, physical component and mental component of quality of life. A study by Comin Colet at al., (2016) with 1037 patients with HF found that patients with HF had worsened Hr-QoL than those general population and with other chronic diseases. 16

17. Literature Review: Factor associated with Hr-QoL in patients with HF Demographics Data Marital status ( D ahlstrom & Brostrom, 2006 ) . Gender (Steptoe, Mohabir, Mahon & McKenna, 2000;Zambroski et al., 2005; Johansson, Dahlstrom & Brostrom, 2006; X u et al., 2015) . Age (Zambroski et al., 2005; X u et al., 2015 ) . Education ( Johansson, Dahlström & Broström , 2006 ; Wang, Sereika , Styn & Burke, 2013) . Economic status ( Kutner , Kassner , & Nowels , 2001 ; Heo , Moser, Chung & Lennie, 2012 ) . Tribe ( Xu et al., 2015 ) . Religion ( Naghi , Philip, Phan, Cleenewerck & Schwarz , 2012) . Illnes-related factors BMI ( Wang, Sereika , Styn & Burke, 2013) . Comorbidity ( R odriguez-Artalejo et al., 2005; Chung et al., 2012) . NYHA class ( Iqbal , Francis, Reid, Murray & Denvir, 20 10; Wang, Thompson, Ski & Liu, 2014 ) . Medication (R odriguez-Artalejo et al., 2005 ) . Readmission frequency ( R odriguez-Artalejo et al., 2005; Comin Colet , 2016). 17

18. Literature Review: QoL and Symptom Burden in HF A cross-sectional study with a sample of 53 patients with HF f ound that p atients with HF experience a high level of symptoms and symptom burden that impact quality of life ( Zambroski et al. 2005) . T he p revious study by Xu et al. (20 15 ) among 147 patients with cancer (41%), chronic HF (37%) and amyotrophic lateral sclerosis (22%) found that patients with chronic HF had the highest mean symptom severity and the lowest Q o L . 18 Physician and Nurse should give intervention to decrease symptom burden and improve H r- Q o L ( Zambroski et al. 2005 Should be aware for symptoms burden in patients with advanced illness (Xu et al., 2015) &

19. Conceptual Framework Demographic data: a ge, g ender, marital status, education, economic status, tribe, religion. Ilness related factors: BMI, comorbidity, NYHA class, HF medication s , admission experience. Symptoms burden: frequency, severity, distress/bother Hr-QoL 1. WHOQOL-BREF (physical, psychological, social and environtment) 2. MLHFQ (physical, emotional) 19 Back

20. Definition of terms : Symptom Burden Theoretical definition S ymptom burden is defined as the patient’s perceptions of the impact of the HF symptoms including prevalence, frequency, severity, and distress that place a psychological burden and may produce negative psychological and emotional responses (Gapstur, 2007). Operational definition T he Memorial Symptoms Assessment Scale -Heart Failure (MSAS-HF) (Zambroski et al., 2005). 20

21. Definition of term s: Hr-QoL Theoretical definition Hr-QoL is defined as a represent of the quality of life focusing on the effects of illness and treatment , that includes domains related to physical, mental, emotional, and social functioning which reflects the ability to function in daily life ( Ferrans , 2005 ; Kawecka-Jaszcz , Klocek , Tobiasz-Adamczyk , & Bulpitt , 2013). Operational definition WHOQOL-BREF (WHOQOL, 1998). Minnesota Living with Heart Failure Questionnaire (MLHFQ), ( Rector, 2005). 21 Back

22. METHODS 22

23. Design (1/2) A cross-sectional research design A convenience sampling technique will be used to recruit the participants. W ill be conducted in outpatient department of cardiology unit at a hospital in East Java, Indonesia . 23 Back

24. Design (2/2) Sample selection Inclusion criteria : P articipants understand Bahasa Indonesia. are a ge d > 18 years old. have HF diagnosed by physician. Exclusion criteria : Parti cipant s have cognitive impairment, data will be confirm from patient’s medical record. terminal Illness (ex. cancer) 24

25. Sampling Sample size G*Power analysis 3.1.9.2 F test Calculation effect size for linear regression analysis (Faul, Erdfelder, Buchner & Lang, 2009) R 2 .22  .28 (Zambroski et al., 2005) α level .05 , a power of .80 , and 18 predictor variables. Needs 105 participants including 18 samples for a 20 % of missing data rate. 25

26. Instruments (1/8) Demographic data will include age, gender, marital status, education, economic status, tribe, and religio n . Illness-related factors will consist of body mass index (BMI) , comorbidity, HF standard medications, New York Heart Association (NYHA), and re - admission experience . 26

27. Instruments (2/8) Memorial Symptoms Assessment Scale -Heart Failure (MSAS-HF) English version (official), will be translated in to Bahasa Indonesia Consisting of 32 questions of symptoms Consists of 3 dimensions: Frequency Severity Distressed And 3 scoring: Global distress index The phhysical symptom subscale score The psychological symptom subscale score 27

28. Instruments (3/8) Originally used to assess symptoms in patients with cancer (Portenoy et al., 1994), was modified from the Portenoy’s MSAS by Zambroski et al., (2004). Frequency: rated on a scale from 1 to 4 (rarely to almost constantly) Severity: 1 to 4 (mild to severe) and Distress: 0 to 4 (not at all to very severe). The higher scores of symptom prevalence, frequency, and severity indicate very much distressed or bothered The Cronbach’s alpha was 0.8 3-0.92 in previous study (Zambroski et al., 2005). 28

29. Instruments (4/8) MSAS-HF GDI = ( the average of the frequency of 4 prevalent psychological symptoms and the distress associated with 6 prevalent physical symptoms )/10 MSAS-HF PHYS= ( the average of the distress associated with 12 prevalent physical symptoms )/12 MSAS-HF PSYCH= ( the average of the frequency associated with 6 prevalent psychological symptoms )/6 29

30. Translation Process Stage I Translation Stage II Synthesis Stage III Backward Translation Stage IV Experts commite review Stage V Testing Two translators (T1 and T2) into Bahasa Indonesia Synthesis T1 and T2 version into (T12) Using T12, back translate to English Evaluate equivalent and content validity (pre final version) Probe to get at understanding of items in population sample Translation process based on Beaton , (2000). 30

31. Instruments (6/8) The World Health Organization Quality of Life (WHOQOL)-BREF Indonesian version Consist of 4 domains: P hysical Psychological Social Environtment Contains 26 questions Score range in each item is 1 to 5 using Likert-type With the higher scores designating higher quality of life It takes approximately 10-15 minutes to fulfill the questionnaire 31

32. Instruments (7/8) Domains of the WHOQOL-BREF Original English version WHO (1996) n= 4802 Bahasa version Salim et al., (2007) n=30 6 Physical Health .82 .74 Psychological .75 .66 Social relationship .66 .41 Environment .80 .77 32 Cronbach’s alpha in F our Domains of the WHOQOL-BREF

33. Instruments (8/8) Mi n nesota Living with Heart Failure Questionnaire (MLHFQ) Indonesian version. Consist of 2 dimensions: P hysical E motional 21 questions assessing the impact of HF. In each item is ranked from 0 to 5 (no impairment to very much impaired). Score range from 0 to 105, the h igher scores meaning poor quality of life. Approximately 5 minutes to fulfill the questionnaire. Cronbach’s alpha was 0.9 2 previous study (Kim, Kim & Hwang, 2014) . 33

34. Ethics and Protection of Human Subjects Ethical Consideration Confidentiality: anonymously and k e ep secret data of the participants. Autonomy: did not force and respect on participants decision. Justice: equal treatment in all participants. Non-maleficiency: no side effect or do not harm to the participants . 34

35. Data Collection Recruit two research assistants and must be ha ve educational background of health. R esearch assistants also will receive training on how to fill out the questionnaire and solve the problems regarding data collection. Data will be collected from May to August 2017. IRB approval will be obtained from the study hospital . Screening eligible participants based on the inclusion criteria. Explain content s and sign inform ed consent by the participants. Fulfill a set of questionnaire for approximately 30 minutes. Collect the data and then a small gift will be given to participants. 35

36. Data Analysis 36 Aims Purpose Statistical methods Aim 1 To understand symptoms burden and Hr-QoL among patients with HF in Indonesia Descriptive statistics Aim 2 To investigate the relationship between demographics, illness-related factors, symptoms burden and Hr-QoL among patients with HF in Indonesia Pearson’s correlation One-way ANOVA t-test Aim 3 To investigate the relationship between symptoms burden and Hr-QoL after controlling for demographic data among patients with HF in Indonesia. Hierarchical regression

37. Expected Result This study is expected to reveal information regarding the relationship between symptoms burden and Hr-QoL in patients with HF. Findings from the study can be used as references for non-pharmacological intervention design such as health education and optimalize the medication treatments to relieve patient’s symptoms. As a result, patients can reach a better Hr-QoL. 37

38. Reference (1) AbuRuz , M., Alaloul , F., Saifan , A., Masa'deh , R., & Abusalem , S. (2016). Quality of Life for Saudi Patients With Heart Failure: A Cross-Sectional Correlational Study. Global Journal of Health Science, 8 (3), 49-58. Bekelman , D. B. (2010). A comparison of two spirituality instruments and their relationship with depression and quality of life in chronic heart failure. Journal of pain and symptom management, 39 (3), 515. Casida , J. and J. Parker (2012). "A preliminary investigation of symptom pattern and prevalence before and up to 6 months after implantation of a left ventricular assist device." Journal of Artificial Organs 15(2): 211-214. Chen, M.-L., & Chang, H.-K. (2004). Physical symptom profiles of depressed and nondepressed patients with cancer. Palliative Medicine, 18 (8), 712-718. Comín Colet, J., et al. (2016). "Health-related Quality of Life of Patients With Chronic Systolic Heart Failure in Spain: Results of the VIDA-IC Study." Revista española de cardiología 69(3): 256-271. Cowie, M. R., Wood, D. A., Coats, A. J., Thompson, S. G., Poole Wilson, P. A., Suresh, V., & Sutton, G. C. (1999). Incidence and aetiology of heart failure; a population-based study. European heart journal, 20 (6), 421-428. Demir , M., & Unsar , S. (2011). Assessment of quality of life and activities of daily living in Turkish patients with heart failure. International journal of nursing practice, 17 (6), 607-614. 38

39. Reference (2) Dunderdale , K., Thompson, D. R., Miles, J. N. V., Beer, S. F., & Furze, G. (2005). Quality-of-life measurement in chronic heart failure: do we take account of the patient perspective? European journal of heart failure, 7 (4), 572-582 . Gapstur , R. L. (2007, May). Symptom burden: a concept analysis and implications for oncology nurses. In Oncology nursing forum (Vol. 34, No. 3). Goodman, H., Firouzi , A., Banya , W., Lau Walker, M., & Cowie, M. (2013). Illness perception, self-care behaviour and quality of life of heart failure patients: A longitudinal questionnaire survey. International journal of nursing studies, 50 (7), 945-953. Heo , S. (2008). Predictors and effect of physical symptom status on health-related quality of life in patients with heart failure. American Journal of Critical Care, 17 (2), 124. Hu, X., Hu, X., Su, Y., & Qu, M. (2016). Quality of Life among Primary Family Caregivers of Patients with Heart Failure in Southwest China. Rehabilitation Nursing . Hwang, S. L., Liao, W. C., & Huang, T. Y. (2014). Predictors of quality of life in patients with heart failure. Japan Journal of Nursing Science , 11 (4), 290-298. Iqbal, J., Francis, L., Reid, J., Murray, S., & Denvir, M. (2010). Quality of life in patients with chronic heart failure and their carers: a 3-year follow-up study assessing hospitalization and mortality. European journal of heart failure, 12 (9), 1002-1008. Kim, H. M., Kim, J., & Hwang, S. Y. (2015). Health-related Quality of Life in Symptomatic Postmyocardial Infarction Patients with Left Ventricular Dysfunction. Asian nursing research , 9 (1), 47-52. 39

40. Reference (3) Lee, C. S., & Auld, J. (2015). Heart Failure: A Primer. Critical care nursing clinics of North America , 27 (4), 413-425 . Lee, K. S., Lennie, T. A., Dunbar, S. B., Pressler , S. J., Heo , S., Song, E. K., ... & Moser, D. K. (2015). The association between regular symptom monitoring and self-care management in patients with heart failure. The Journal of cardiovascular nursing , 30 (2), 145-151. Ministry of Health Indonesia. (2014). Situasi kesehatan jantung . Naghi , J., Philip, K., Phan, A., Cleenewerck , L., & Schwarz, E. (2012). The Effects of Spirituality and Religion on Outcomes in Patients with Chronic Heart Failure. Journal of Religion and Health, 51 (4), 1124-1136. Negarandeh , R., Delkhosh , M., Janani, L., Samiei , N., & Ghasemi , E. (2015). The Relationship between Perceived Life Changes and Mental Health in Family Caregivers of Patients with Heart Failure who Referred to Rajaei Cardiovascular Medical and Research Center , Tehran. International journal of community based nursing and midwifery, 3 (4), 283. Obiegło , M., Uchmanowicz , I., Wleklik , M., Jankowska-Polańska , B., & Kuśmierz , M. (2016). The effect of acceptance of illness on the quality of life in patients with chronic heart failure. European Journal of Cardiovascular Nursing , 15 (4), 241-247. 40

41. Reference (4) Ponikowski , P., Voors , A., Anker, S., Bueno, H., Cleland, J. G. F., Coats, A. J. S., . . . van der Meer, P. (2016). 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. European heart journal, 37 (27), 2129-2200. Tatukude , C., Rampengan , S. H., & Panda, A. L. (2016). Hubungan tingkat depresi dan kualitas hidup pada pasien gagal jantung kronik di Poliklinik Jantung RSUP Prof. Dr. RD Kandou Manado. e- CliniC , 4 (1). Xu, J., Nolan, M. T., Heinze , K., Yenokyan , G., Hughes, M. T., Johnson, J., ... & Gallo, J. J. (2015). Symptom frequency, severity, and quality of life among persons with three disease trajectories: cancer, ALS, and CHF. Applied Nursing Research , 28 (4), 311-315 Xu, J., Nolan, M., Heinze , K., Yenokyan , G., Hughes, M., Johnson, J., . . . Lee, M. (2015). Symptom frequency, severity, and quality of life among persons with three disease trajectories: cancer, ALS, and CHF. Applied nursing research, 28 (4), 311-315. Zambroski , C., Moser, D., Bhat, G., & Ziegler, C. (2005). Impact of symptom prevalence and symptom burden on quality of life in patients with heart failure. European journal of cardiovascular nursing, 4 (3), 198-206. 41

42. Thank You 42