Healthcare for Patients with Interstitial Cystitis/Bladder Pain Syndrome Based on Internet Health Education Ming-Huei Lee1,2, Huei-Ching Wu2,3, Jen-Yung Lin4, Yung-Fu Chen3, John Y. Chiang5, Tan-Hsu Tan6 1

Dept. of Management Infor. Syst., Central Taiwan University of Science and Technology, Taichung, Taiwan Department of Urology, Fong-Yuan Hospital, Department of Health, Executive Yuan, Taichung, Taiwan 3 Dept. of Healthcare Administration, Central Taiwan University of Science and Technology, Taichung, Taiwan 4 Department of Computer Science and Information Engineering, Da-Yeh University, Changhua, Taiwan 5 Department of Computer Science and Engineering, National Sun Yat-sen University, Kaohsiung. Taiwan 6 Department of Electrical Engineering, National Taipei University of Technology, Taipei, Taiwan

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Abstract—Interstitial cystitis (IC) is a chronic disease which highly degrades the quality of life for patients. The objective of this study is to adopt Internet intervention for caring IC patients to alleviate their pains and bothering syndromes. Healthcare education was conducted through Internet by asking the patients, divided into study and control groups, to check contraindications, habits, and behaviors weekly to remind and consolidate important rules for promoting quality of life (QOL). Questionnaires, including SF-36, O’Leary-Sant symptom and problem indices, and VAS pain and urgency scales, were used to evaluate improvements of quality of life before and after ICT intervention. The results show that the QOL of patients in the study group with ICT intervention have been significantly improved compared to the patients in the control group. The E-health system was demonstrated to be effective in improving QOL of IC patients through intervention of Internet healthcare education for the consolidation of healthy dieting habit and life style. Index Terms—Interstitial Cystitis (IC), Information and Communication Technology (ICT), Mobile Phone, E-Health, Quality of Life.

I. INTRODUCTION

I

nterstitial cystitis /bladder pain syndrome (IC/BPS) is a chronic bladder disease characterized by suprapubic pain related to bladder filling, urgency, frequency, and nocturia in the absence of proven urinary infection or other definable pathologic etiology [1]. The cause of the disease is unknown. Whether it is originated from the bladder or other pelvic organs or is a systematic disease is still not elucidated [2]. Dyspareunia is also widely observed in female IC/BPS patients with pain as the most important finding significantly degrading the quality of life [3,4]. It is estimated to occur in 49-90% of the IC/BPS patients; among them, 54% intended to avoid intercourse most of the time because of incurred sex pain [5]. Sex pain is a strong indicator of poor quality of life for IC/BPS patients [6,7]. The

results of RAND interstitial cystitis epidemiology study showed that female IC/BPS patients experience much higher level of sexual dysfunction (88% vs 43%), such as lack of sex interest (64% vs 31%), arousal difficulties (61% vs 19%), and pain (67% in bladder; 52% in genital area vs 15%), compared to the general population [8,9]. The overall prevalence of IC/BPS is 0.68% in Finland [10], 2.7-6.5% in the USA [11], and 1.1% for male and 2.4% for female in the Swedish population [12]. However, it is likely under-diagnosed and under-estimated according to a study performed recently in the United States [13]. IC/BPS patients always suffer from sleep disorder, working limitation, and stress [14]. It was reported that the physical and mental status of the IC/PBS patients are significantly worse than general population [15], greatly deteriorating their quality of life. Serious isolation from regular social life, unable to work normally, acquisition of depression, or commitment of suicide was also observed in some patients [16,17]. The IC/PBS treatments are very diverse. Currently, there is no single therapy which is effective in treating the disease. Clinically, the patients have been long annoyed by the disease making them suspect to further supportive therapies, such as medication prescriptions or other invasive treatments. Most of the patients visit their physicians to seek only supportive therapies, resulting in the waste of medical resource, deficiency of effective healthcare, and degradation of quality of life. The IC/PBS disease also imposes great economic loading for the patients and their country. The cost induced includes direct healthcare expenditure, as well as indirect loss caused by unemployment. It was reported that the direct cost in treating the IC patients is 2-3 times more than non-IC patients with an increase of direct cost of 4000 US$ compared to their age-matched counterparts [18]. An increase of indirect cost caused by unemployment and other social costs was also reported [19].

A. Application of ICT in Health Care By taking poor compliance of self-management regimens into consideration, Celler et al. [20] proposed a Home Televare System to monitoring physiological signs, scheduling and reminding medication, and healthcare education. It was demonstrated to be effective in early identification of adverse events to avoid hospital readmission or to reduce length of stay in hospital. Izquierdo et al. [21] reported that the home telemedicine system applied to transmit blood glucose and blood pressure data of elder patients with Type 2 diabetes to a nurse case manager is effective in identifying and remediating urgent situations. It highly decreased their mortality and morbidity for a patient to adopt videoconference to communicate with a nurse or dietitian for diabetes management and access website data for education every 4-6 months. Sehati et al. [22] tested an Internet-based ambulatory patient monitoring system to continuously monitor 8 physiological signs and transmitted to a PDA through either wired link or wireless links (infrared or Bluetooth). The signals were then transmitted to a central server for further processing and for storing in a relational database from the PDA. It demonstrated the feasibility and need of a programmable system for remote monitoring and advising in clinical setting. Recently, an integrated wireless system was designed and proposed to monitor vital signs and locations of unattended patients at emergency department or disaster sites [23]. In this system, wireless vital signs (ECG and SpO2) monitoring, geo-positioning, signal processing, targeted alerting, and wireless caregiver interface modules were integrated to achieve the objective of caring overcrowded unattended patients. The prototype was demonstrated to be capable of detecting alarms which showed vital conditions of unattended patients and their locations so that the caregivers could immediately locate the patients and do suitable treatment. More recently, a system which used cellular phone based on Internet to care obese patients with hypertension for improving their blood pressure, weight control, and serum lipids [24]. The intervention was done by simply asking patients to record their blood pressure and body weight weekly through Internet or by cellular phone. Additional intervention was to send optimal recommendations to the patients weekly. It was demonstrated that the intervention by sending simple messages through cellular phone and Internet can significantly decrease blood pressure, as well as effectively reduce body weight and waist circumference. The similar intervention was also shown to be effective in decreasing blood glucose levels of obese type 2 diabetes patients [25]. To the best of our knowledge, E-health system has never been applied for caring patients with IC/BPS before. The motivations of this study are summarized as follows: (1) it is impossible to completely cure IC disease currently using a general treatment, an individual case might need different treatment from the others, hence finding methods to alleviate the pains and

symptoms may be effective to promote quality of life; (2) although IC is not a malignant disease, treatment of IC patients needs a lot of healthcare resources and may cause a great burden for the country; and (3) intervention using mobile phone and Internet is effective in caring patients with chronic diseases in outpatient and ambulatory settings. The objective of this study is as follows: (1) to develop an E-health system by integrating mobile phone and Internet for caring IC patients to alleviate their pains and symptoms; (2) to effectively care IC patients through the intervention of a IC/BPS healthcare team consisting of nursing case managers and urologists to improve the quality of life of IC/BPS patients. In this study, nursing case managers are responsible to communicate with IC/BPS patients through short message service (SMS) provided by the mobile phone and Internet to elevate healthcare efficiency by directly solving their complaints or problems through real-time response. In addition, healthcare education can be reinforces through Internet by asking the patients to check food contraindications, daily activities, and living habits weekly to remind and consolidate important rules for promoting quality of life.

II. MATERIALS AND METHODS In this study, a web service designed for providing health education and administrating questionnaires were used for health care and health management of IC/BPS patients. The information of educational material for IC patients was included in the webpage of the Taiwan Interstitial Cyscitis Association (TICA) website (http://taic.hopto.org). A.

System Design The architecture of the web-based IC/BPS healthcare and management system (HMS) is shown in Fig. 1. As shown in this figure, the web service was installed in the web server to respond or communicate with the mobile phone by sending/receiving short messages through Hinet message center. The IC/BPS HMS can be linked from the TICA website. The data flow is illustrated as follow: Client Side Computer ↔ Socket to Air API ↔ Socket to Air Server ↔ Message Center ↔ Mobile Phone. ASP .NET C# was adopted to develop the web service system. The MS IIS7 and MS SQL Express were used to handle the web server and database management system, respectively.

Fig. 1. System architecture.

B. Health Education Table I shows the items used for health education. The patients receiving ICT intervention were asked to check the items weekly. Participants who forget to fill the form will be noticed by email or simple mobile phone message. TABLE I WEEKLY CHECK FOR CONSOLIDATING THE BEHAVIOR PROMOTED BY HEALTH EDUCATION

Please check “Yes” or “No” based on your experience during the past week. Y N Item Description 1 Do you follow the suggested diets? 2 Do you drink 1500 c.c. of water or so daily? Do you eat banana, pine apple, citrus fruit, or other food 3 containing a great amount of potassium. Do you drink any beverage which contains alcohol, coffee, 4 vinegar, or tea? 5 Do you smoke? Have you done mild aerobic exercise, such as yoga, hiking, 6 jogging, etc,? Do you wear cozy, loose clothes, and put on underwear 7 mainly made of cotton? If you don’t have pain or sexual intercourse, please check “Unavailable”, otherwise check “Yes” or “No” according to your personal experiences. Y N NA Description I have bathed the whole lower abdomen with warm water (40oC) more than once a day, each lasting for 8 15 minutes, or placed a heat pad over the abdomen to keep it warm to relieve uncomfortable symptom. I have tried to relax my body muscles through meditation to decrease the activation of sympathetic 9 nervous system and tension, or used a heat pad to relieve uncomfortable symptom. I have used lubricant (ointment) to relieve 10 uncomfortable feeling during intercourse. When feeling uncomfortable during intercourse, I 11 have changed the posture to the top position to maneuver the force exerted and alleviate the feeling of pain. 12 I have washed and cleaned the vulva and keep them dry after the intercourse. I have bathed the whole abdomen with warm water 13 (40oC) for 20 minutes to decrease the occurrence of pelvic pain.

C. Subjects and Disease Diagnosis Currently, the diagnosis of IC/BPS disease is still challenging that evidence-based diagnosis of the disease is still insufficient [26]. In this study, the diagnosis was based on the inclusion and exclusion clinical criteria proposed by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) guideline [27]. The inclusion clinical diagnosis criteria include cystoscopic observations, i.e. glomerulations and/or classic Hunner’s ulcer and symptoms, i.e. bladder pain and/or urinary urgency, in the absence of other bladder diseases. Exclusion clinical diagnosis criteria are as follows: (1) bladder capacity greater than 350 c.c. on awake cystometry; (2) absence of and intense urge to void with the bladder filled to 100 c.c. during cystometry using a fill rate of 30-100 cc/min; (3) demonstration of phasic involuntary bladder contractions on cystometry using the fill rate described in number (2); (4) duration of symptoms less than 9 months; (5) absence of nocturia; (6) symptoms relieved by antimicrobials, urinary antiseptics, anticholinergics, or antispasmodics; (7) frequency of urination while awake of less than eight times a day; (8) diagnosis of bacterial cystitis or

prostatis within a 3-month period; (9) bladder or ureteral calculi; (10) active genital herpes; (11) uterine, cervical, vaginal, or urethral cancer; (12) urethral diverticulum; (13) cyclophosphamide or any type of chemical cystitis; (14) tuberculous cystitis; (15) radiation cystitis; (16) benign or malignant bladder tumors; (17) vaginitis; and (18) age less than 18 years. A total of 80 patients were recruited from the urological clinic of a hospital located in central Taiwan and randomly assigned to either the study group (N=40) or the control group (N=40). Among them, 7 patients in the study group and 8 in the control group were excluded because they failed to fill the questionnaires in either pre- or post- test. Only the data of 65 patients, 33 in the study group and 32 in the control group, were used for further analysis. In addition to regular treatment, patients in the study group were asked to self-manage their diets and life styles by responding health education questions weekly so that their compliance in following the suggestions in the provided materials can be checked. This intervention is expected to be useful for changing and consolidating their habitual behavior. In contrast, only routine treatment was administrated to the patients for the patients of the control group. The study was approved by the IRB of Taichung Hospital, Department of Health of Taiwan. Table II compares the demographic information of the patients in the study and control groups. It can be observed that there is no significant difference (p>0.05) between two groups with regard to age, marriage, and education. TABLE II COMPARISON OF DEMOGRAPHIC INFORMATION BETWEEN STUDY AND CONTROL GROUPS

Demographic Information Age in year (Mean±SD) High School Education University Yes Marriage No

Control (N=32) 49.5±11.8 15 (46.9%) 17 (53.1%) 30 (93.8%) 2 (6.2%)

Study (N=33) 46.5±10.2 19 (59.4%) 14 (40.6%) 27 (81.2%) 6 (18.8%)

p-value 0.28 0.39 0.14

D. Experimental Paradigm In this study, information and communication technology (ICT) was adopted as the intervention to elevate healthcare quality of IC/BPS patients. The questionnaires, including SF-36 health survey, visual analogue scales (VAS) for the measurement of pain and urgency, and O’Leary-Sant symptom and problem indices, were administrated to measure the patient perception of health status before (pre-test) and after (post-test) ICT intervention spanning a period of 2 months. The questionnaire results of pre- and post-tests were compared to observe if any difference in improvement of quality of life between the study and control groups. The outcome of the ICT intervention was evaluated based on the improvement of the health status of the participating patients. Figure 2 depicts the experimental procedure. As shown in this figure, ICT intervention provides health education for

Baseline

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Control Group IC Patients

F1-F3

R

R

R

R

Baseline

W1

W2

W3

W4

……

R+F1-F3

Study Group W8

R: Weekly Health Education F: Questionnaires F1: SF-36 Survey F2: O’Leary-Sant Symptom and Problem Indices F3: VAS Pain & Urgency Scales Fig. 2. Experimental procedure. consolidating healthy dieting habit and life-style. Since all the recruited patients are female, the control variables used to eliminate variations between two groups include demographic information, i.e., age, education, and marriage status. O’Leary-Sant symptom and problem indices and visual analogue scale (VAS) pain and urgency scales were used to quantify disease severity of the patients. E. ICT Intervention IC/BPS patients are very sensitive to diets, such as foods, drinks, supplements, and spices [28-31]. Hence, to educate the patients in consuming healthy comestibles and preventing contraindications is expected to be effective in preventing their recurrence. A web service was designed to promote healthy diets and life styles for the patients by asking them to check and follow the diets and life styles suggested by the physician. The service can be accessed by the patients after login to the web site of TICA (Taiwan Interstitial Cystitis Association) through an Internet browser. The participating patients were asked to fill the questionnaire of health education once a week to consolidate their concepts of healthy diets and life-styles promoted by the educational materials. We hypothesize that the patients will learn to eat healthy diets and live with healthy life-styles to prevent reoccurrence of IC/BPS outbreaks through repetitive health education. The case manager can also learn the diets and life-styles of individual patients through the web service. If the patients forget to check the health educational materials, the system will automatically send messages to remind them. Table I lists the diets and life-styles suggested by the physician in the educational materials. F. Statistic Analysis and Outcome Evaluation Descriptive statistics were used to analyze the demographic information, disease severity, and questionnaires of the recruited patients, while the inferential statistics (student’s t-test)

applied to compare the improvement of health status and symptoms between the study and control groups. SAS was adopted as the tool for statistic analysis. III. EXPERIMENTAL RESULTS Table III compares the SF-36 health survey of the IC/BPS patients between the study and control groups before ICT intervention. It can be found that, except general health, there is no significant difference (p>0.05, unpaired Student’s t-test) for the other 7 items between the two groups. The disease severity quantified with O’Leary-Sant indices and VAS scales before ICT intervention is compared in Table IV. As shown in the table, the disease severity presents no significant difference (p>0.05, Student’s t-test) between patients in two groups. TABLE III COMPARISON OF SF-36 HEALTH SURVEY FOR PATIENTS BETWEEN CONTROL AND STUDY GROUPS BEFORE ICT INTERVENTION Items

Control (N = 32)

Study (N = 33)

Physical function 81.88±18.17 72.12±23.19 Role physical 63.28±38.62 48.48±44.61 Bodily pain 63.78±26.31 52.24±24.05 General health* 54.38±22.69 38.61±23.81 Vitality 48.28±13.95 42.73±21.25 Social function 66.02±18.58 62.88±25.67 Role emotional 59.38±43.78 45.45±47.01 Mental health 53.38±18.81 47.15±19.99 Note: Unpaired Student’s t-test with *p