CLINICAL ISSUES

Education for patients with chronic kidney disease in Taiwan: a prospective repeated measures study
Miaofen Yen, Jeng-Jong Huang and Hsiu-Lan Teng

Aim. To investigate the physical, knowledge and quality of life outcomes of an educational intervention for patients with early stage chronic kidney disease. Background. A comprehensive predialysis education care team can be effective in slowing the progression of chronic kidney disease. Design. A single group repeated measures design was used to evaluate the effects of the intervention. Methods. Participants were recruited through health department community health screen data banks. A predialysis, teamdelivered educational intervention covering renal function health care, dietary management of renal function and the effects of Chinese herb medication on renal function was designed and implemented. Data were collected at baseline, six and 12 months. Study outcomes included physical indicators, knowledge (renal function protection, use of Chinese herbs and renal function and diet) and quality of life. Data were analysed using repeated measure ANOVA to test for change over time in outcome variables. Results. Sixty-six persons participated in this study. The predialysis educational intervention showed signicant differences at the three time points in overall knowledge scores, waisthip ratio, body mass index and global health status. Knowledge measures increased at month 6 and decreased at month 12. The primary indicator of renal function, glomerular ltration rate, remained stable throughout the 12 months of follow-up, despite the relatively older mean age of study participants. Conclusion. A predialysis education care team can provide effective disease-specic knowledge and may help retard deterioration of renal function in persons with early-stage chronic kidney disease. The intervention dose may need to be repeated every six months to maintain knowledge effects. Relevance to clinical practice. A predialysis educational program with disease-specic knowledge and information is feasible and may provide positive outcomes for patients. Topics on the uses of Chinese herbs should be included for people who are likely to use alternative therapies. Key words: chronic kidney disease, education program, nurses, nursing, Taiwan
Accepted for publication: 13 January 2008

Introduction
Chronic kidney disease (CKD) is a major public health problem in many countries (K/DOQI Work Group 2002).

Patients with CKD are at high risk of progressing to renal failure with adverse physical outcomes over time. Risk factors for CKD can be classied into modiable and nonmodiable. Modiable factors include blood pressure, blood

Authors: Miaofen Yen, PhD, RN, Associate Professor, Department of Nursing & Institute of Allied Health Sciences, College of Medicine, National Cheng Kung University, Tainan City, Taiwan; Jeng-Jong Huang, MD, Professor, Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan City, Taiwan; Hsiu-Lan Teng, MS, RN, Instructor, Foo-Yin Technology University, Kaohsiung, Taiwan; and Doctoral Student, Institute of Allied

Health Sciences, College of Medicine, National Cheng Kung University, Tainan City, Taiwan Correspondence: Miaofen Yen, Associate Professor, Department of Nursing & Institute of Allied Health Sciences, College of Medicine, National Cheng Kung University, 1, University Road, Tainan City 701, Taiwan. Telephone: +886 6 2353535 (ext) 5823. E-mail: miaofen@mail.ncku.edu.tw

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sugar, blood lipids, use of tobacco and alcohol, diet, medication misuse and obesity. Non-modiable factors include age, gender, race and genetics (Brown et al. 2003, de Jong & Brenner 2004). Ageing has been shown to be associated with a decline in renal function (Brown et al. 2003). Obesity [body mass index (BMI) of more than 30 kg/m2], especially abdominal obesity, is frequently accompanied by several factors in addition to hypertension that may accelerate the risk for CKD. Abdominal obesity refers to subjects with central fat distribution and is a major risk factor for renal function abnormalities (Pinto-Sietsma et al. 2003, Kramer et al. 2005). Because the number of nephrons does not increase after birth, increasing body weight must result in an increase in the single nephron glomerular ltration rate (GFR) (Kramer et al. 2005).The early stage of CKD is often asymptomatic; when symptoms do arise with progression towards renal failure, it is often too late to change behaviours to preserve renal function. Chagnac et al. (2003) showed that therapeutic interventions were often ineffective at the end stage of CKD. Therefore, current standards call for early intervention for patients with progressive CKD. Many studies have shown that early stage CKD patients who received predialysis education had lower hospitalisation rates and shorter lengths of stay when hospitalised than those who did not receive health education. Researchers have also indicated that patients with predialysis care experienced less urgent dialysis (Levin et al. 1997) and better biochemical parameters at the start of dialysis therapy (Devins et al. 2003, Goldstein et al. 2004, Tungsanga et al. 2005). Early intervention to retard renal function deterioration was recommended when patients serum creatinine (Scr) level was 1530 mg/dl, or GFR level is from 30 to 59 ml/minutes (Hebert et al. 2001). Such results indicate that predialysis education programs could be benecial for CKD patients. In contrast, some results of predialysis care have been inconsistent; intensive predialysis management showed little effect on mortality or kidney function deterioration (Devins et al. 2003, Goldstein et al. 2004, Tungsanga et al. 2005). Also, investigators have concluded that intensive predialysis management may not be cost effective (Harris et al. 1998). In addition to biological outcomes, researchers have stressed that psychosocial indicators should be considered in follow-up research (Devins et al. 2003). The literature indicates that quality of life (QOL) is a better measure of comprehensive responses to the physical, mental and social dimensions often measured separately by psychosocial instruments. QOL has become an important variable in the evaluation of therapeutic interventions (Valderrabano et al. ` 2001). Many studies have recognised that the QOL of
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patients with established renal failure is less than that of the general population (Valderrabano et al. 2001, Suet-Ching ` 2001, Patel et al. 2002). But few studies have measured the QOL of patients in the early stage of CKD. In Taiwan, alternatives to contemporary medicine are readily available and commonplace. Patients with impaired renal function often use alternative treatments, especially traditional Chinese herbs. A phenomenological study indicated that, after being diagnosed with established renal failure, patients in Taiwan seek further information, including getting a second opinion from a traditional Chinese medicine specialist and explore alternative treatment to recover renal function (Lin et al. 2005). Many Taiwanese believe that traditional herbs are natural and thus harmless. Long periods of information seeking, however, can cause treatment delays and prevent the patient from receiving effective treatment in time (Sesso & Yoshihiro 1997, Lin et al. 2005). In addition, the improper use of herbal medicine can deteriorate kidney function. Therefore, health education for CKD patients that includes information on the use of Chinese herbal medicine could be an appropriate method to prevent or retard the development of renal failure in Taiwan. Patients with CKD have been identied as a patient group in need of specic education (Goldstein et al. 2004, Tungsanga et al. 2005). A predialysis educational program may produce important benets by increasing illness-related knowledge and promoting QOL (Harris et al. 1998, Klang et al. 1999). More research is needed to understand the effects of an educational intervention on patients with early stage CKD. Thus, a multidisciplinary predialysis care team was convened to develop an intervention designed to improve renal function protection in persons with early stage CKD. Such an educational intervention has not been previously developed and evaluated in Taiwan. Therefore, the purpose of this study was to investigate physical, knowledge and QOL outcomes of an educational intervention for patients with CKD.

Methods
This study used a one-group repeated-measures design. An educational intervention delivered by a multidisciplinary predialysis care team and focused on renal function protection for people with CKD was held with follow-up data collection. Outcomes physical indicators, QOL and knowledge of renal function protection were measured at baseline, six and 12 months. Throughout the 12-month period, participants were able to contact the predialysis care team with any questions about CKD.

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Participants and setting

The study was approved by the institutional review boards of participating hospitals. After approval by the Health Department of Tainan City, a health screening data bank (n = 2071) was obtained. The rst step was to screen for people with Scr. between 15 and 3 mg/dl. A total of 640 potentially eligible persons were identied. Each person was contacted by telephone and invited to participate in the study. Among the 640 persons identied in the initial screening process, reasons for not participating were inconvenience of transportation, not interested in the intervention and having an alternative treatment plan. Some decided not to participate without giving any reason. One hundred and fty four persons agreed to participate. Each of the 154 persons next visited a nephrologist at their convenience to determine study eligibility. Inclusion criteria included: (1) Scr between 15 and 3 mg/dl; (2) diagnosed as CKD by their doctors; (3) aged 18 years or older; and (4) spoke Mandarin or Taiwanese. Of the 154 who initially agreed to participate, 66 persons fullled the selection criteria. All participants gave written informed consent prior to data collection.

multidisciplinary team served as a resource for the case manager in consultations.

Instruments
Study instruments included physical indicators, World Health Organisation Quality of Life (WHOQOL) questionnaire, renal protection knowledge checklist and demographics. The research assistant called the participants prior to their regular outpatient clinic check up and reminded them for the followup data collection every six month. Face-to-face interview for individual questions and measuring study outcomes were performed at follow-ups. Physical indicators The renal function assessment consisted of Scr., blood urea nitrogen (BUN) and GFR. The GFR was estimated by the CockcroftGault prediction formula (K/DOQI Work Group, 2002): GFR 140 age BWkg 085 if female=Scr. 72 Body composition, including body weight, muscle weight, percentage body fat, body fat, waist to hip ratio (WHR) and BMI, were measured by IN BODY 3.0 Body composition analyser (IN BODY 3.0 Biospace (Upwards Biosystems Ltd, Taipei, Taiwan); Okamoto et al. 2006). Blood pressure was taken in a seated position using an automated sphygmomanometer. Quality of life: the World Health Organisation quality of life questionnaire Quality of life was evaluated using WHOQOL-BREFTaiwan Version (The WHOQOL Taiwan Group, 2000), a 28-item instrument. The WHOQOL-BREF Taiwan Version encompasses four domains: physical health (seven items), psychological health (six items), social relationships (four items), environmental domain (nine items) and two global items (In general, How would you rate your quality of life? and In general, How satised are you with your health?). This instrument measured patients QOL during the two weeks prior to data collection points with a 5-point Likert scale: 1 = not satised at all, 2 = somewhat satised, 3 = moderately satised, 4 = very satised and 5 = extremely satised. Higher scores indicated a better QOL. The reliability of the overall questionnaire was 090 (The WHOQOL Taiwan Group 2000). Internal consistency for each of the four domains ranged from 068077. Content validity, convergent validity, criteria-related validity and construct validity were examined. The overall QOL internal

Educational intervention
The educational intervention consisted of one workshop, individual consultations every six months and a telephone number for participant questions. The predialysis care team for the workshop consisted of a nephrologist, nurse, nutritionist and social worker. The workshop included content on renal protection, nutrition, exercise and the use of Chinese herbal medicine. An educational handout describing CKD disease-related information was given to each participant. The physician focused on the context of renal function, pharmacological management and the causes of CKD, as well as the use of Chinese herbal medicine. The nurse provided information on health promotion for renal function protection. The nutritionist covered content on diet for people with decreased renal function, including information on foods to choose and to avoid. The social worker raised the issue of support systems for people with CKD. The workshop lasted for 150 minutes with two short breaks. Desserts recommended by the nutritionist were provided during the breaks for educational purposes. Lunch boxes were also designed by the nutritionist and given to the participants at the end of the workshop. A masters-prepared nurse case manager performed the individual consultations and answered phone calls from the participants. Individual consultations and measures of the study indicators at the sixth and twelfth month were undertaken at the same time. The

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consistency for this study was 093. Internal consistency for each of the four domains ranged from 073083. Renal protection knowledge checklist A disease-specic knowledge of renal protection checklist was developed for this study. Two nephrologists and three nurses with at least ve years of clinical experience with CKD evaluated the content validity prior to the study. The checklist consisted of 20 items covering three domains: renal function protection (11 items), knowledge of using Chinese herbs in related to renal function (ve items) and diet with CKD (four items). Item responses were dichotomous, i.e. true or false. Each correctly answered item was scored with ve points. Total scores for the checklist ranged from 0 to 100. Higher scores indicated higher knowledge of renal function protection. The reliability of the questionnaire was from 043054. Demographics Demographic variables included gender, age, language, tobacco and alcohol use, state of residence, level of education, occupation and personal medical history (self-report).

analysis with fewer subjects. Therefore, in this study we applied repeated measures ANOVA to determine whether physical indicators (renal function and body composition), QOL and knowledge of renal function protection differed among baseline, six and 12 month time points. There might be correlation between the measures across time for each variable because they were from the same people, (Munro 2005:215) also known as compound symmetry. Mauchlys test of Sphericity was non-signicant (p > 005) and thus the assumption of compound symmetry was met, indicating that the correlations across the measurements were the same and the variances were equal across measurements. Statistical signicance was set at p < 005 and all p-values were reported two sided.

Results
Study sample
Data from 66 participants were analysed in this study. Fiftythree participants were males and 13 (20%) were females. The mean age was 674 years (range 3389 SD 1159). The average years of education were nine (SD 45). Forty-four participants (67%) were married. More than half of the participants were Buddhist (n = 36, 55%). Most of the participants were retired or unemployed (n = 47, 71%). The average range of income was between 015, 000 NT dollars (approximately 0470 US dollars) per month. Seven (11%) participants smoked and only one participant drank alcohol regularly.

Data analysis
Statistical analyses were conducted using SPSS (version 14.0) (SPSS Taiwan Corp., Taipei, Taiwan). All continuous variables were examined assuming normal distributions. Descriptive statistics (means, standard deviations and frequencies) were examined for all study variables. Repeated measures analysis of variance (ANOVA) was used for variables collected longitudinally at three points (baseline, six and 12 months) to test the equality of means across times, known as the within-subjects effects. Using the repeated measures can reduce the error term, thus increase the power of the
Baseline mean (SD) 421 21 286 1415 842 682 466 225 103 254 (106) (05) (03) (160) (83) (87) (59) (46) (02) (33) Sixth month Mean (SD) 411 22 308 1410 849 678 465 223 101 251 (111) (07) (104) (157) (74) (86) (60) (46) (01) (34) Twelfth month Mean (SD) 412 21 295 1419 847 684 460 228 100 250 (117) (07) (130) (159) (76) (81) (57) (44) (01) (33)

Physical indicators
Table 1 summarises the physical indicator outcomes. The major criterion for selection of participants in this study
Table 1 Physical indicators at three time points (n = 66)

Variable GFR Scr BUN SBP DBP Body weight Muscle weight Body fat WHR BMI

F 287 150 104 287 272 278 285 287 603* 437*

Post hoc

12* 12*

*p < 005. GFR, glomerular ltration rate; Scr, serum creatinine; BUN, blood urea nitrogen; SBP, systolic blood pressure; DBP, diastolic blood pressure; WHR, waisthip ratio; BMI, body mass index.

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was Stage 3 of CKD, GFR range from 30 to 59 ml/ minutes/173m2. Data from the baseline, sixth and twelfth month follow-ups showed that the indicators of renal function (Scr., BUN and GFR) were not signicantly different over time (F = 104287; p > 005). Body composition (body weight, muscle weight, body fat percentage and total body fat) was also not signicantly different at the three time points. However, both WHR and BMI were signicantly different at the three time points (F = 603 and F = 437; p < 005). Other physical indicators, including systolic blood pressure and diastolic blood pressure, were not signicantly different within the 12-month follow-up period.

Quality of life
The brief version of the WHOQOL contains four domains with 26 items. Thirty eight participants completed the QOL questionnaire in this study (the remainder left 20% or more items blank and thus could not be included in analysis). The mean age of those who did not complete the QOL questionnaires was younger than the 38 participants who did (p < 005). Other demographic variables (gender, education level, religion and marital and job status) were similar for these two groups (p > 005). Table 3 depicts the QOL results. There were no signicant differences at baseline, sixth and twelfth month follow-ups in the physical, psychological, social relationship and environmental domains. Two single items were asked to evaluate global QOL and health status: How would you rate your quality of life? and How satised are you with your health? The scores for satisfaction with personal health increased signicantly (F = 964; p < 005). However, the global QOL item score increased at the sixth month and decreased at the twelfth month (F = 995; p < 005).

Knowledge checklist
The 20-item knowledge checklist contained three domains: renal function protection, knowledge of using Chinese herbs related to renal function and diet with CKD. The overall knowledge scores, covering all three domains, increased at the sixth month and decreased at the twelfth month (p < 005; Table 2). Similarly, scores from two domains, knowledge of using Chinese herbs and diet with CKD, increased at six months and decreased 12 months (p < 005). However, the renal function protection domain showed no signicant change over time.
Table 2 Renal function protection knowledge at three time points (n = 66)

Discussion
These results show that renal function was stable in this sample over the 12 months of the study. The physical

Variable Overall protection renal function knowledge Subscales Renal function protection Use of Chinese herbs Diet with CKD

Baseline mean (SD) 856 (60)

Sixth month Mean (SD) 920 (50)

Twelfth month Mean (SD) 842 (60)

F 1039*

Post hoc 12* 23*

468 (57) 224 (38) 178 (34)

485 (62) 227 (35) 189 (27)

484 (51) 193 (51) 175 (34)

24 139* 348*

12* 23* 12* 23*

*p < 005. CKD, chronic kidney disease.

Table 3 Quality of life at three time points (n = 38)

Variable Global QOL (single item) Global health status (single item) Physical domain Psychological domain Social-related domain Environment domain

Baseline mean (SD) 31 (06) 27 (08) 138 125 134 146 (18) (16) (19) (22)

Sixth month Mean (SD) 32 (08) 32 (09) 139 128 136 151 (19) (17) (15) (15)

Twelfth month Mean (SD) 26 (08) 33 (10) 138 129 137 145 (20) (13) (22) (22)

F 964* 995* 007 111 042 186

Post hoc 23* 12*

*p < 005; Thirty-eight participants completed the QOL questionnaire. QOL, quality of life.

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indicators (Scr, BUN and GFR) were not signicantly changed across time (p = 005). Two outcome physical indicators in this study, the WHR and BMI signicantly decreased over the 12-month follow-up period. Knowledge scores (using Chinese herbs and diet with CKD) increased at 6 months and decreased at 12 months. There was no signicant difference among scores for four domains of QOL. However, the two global items, overall QOL and general health, showed change over time (p < 005). Overall QOL was increased at six months and decreased at 12 months, while general health (as measured by the satisfaction with personal health item) increased over time.

Changes in renal function

The level of GFR is widely accepted as the best indicator of overall kidney function and the denition and staging of CKD depends on the assessment of GFR (Levey et al. 1999, K/DOQI Work Group 2002). GFR levels were not signicantly changed during baseline, six and 12 month follow-ups in this study. The results were consistent with the ndings from a randomised, controlled trial predialysis education study (Klang et al. 1999, Devins et al. 2003). Another longitudinal study in Thailand reported similar ndings: GFR seemed to be stable over a four-year follow-up after implementing a multidisciplinary educational intervention (Tungsanga et al. 2005). Retarding or preventing deterioration of renal function as measured by GFR levels is a key task of early stage CKD educational intervention. The GFR level was stable among participants in this study, even though the mean age, 674-year old, was older than reported in other studies (Levin et al. 1997, Devins et al. 2003), indicating that the educational intervention may have been successful in retarding deterioration of renal function in spite of age, a major risk factor for declining renal function (Brown et al. 2003).

over 14 years found that higher BMI was a risk for hypertension and diabetes, both of which increased the risk of ESRD (Gelber et al. 2005). Two outcome indicators in this study, WHR and BMI, signicantly decreased over the 12-month follow-up period. This nding may help explain why the renal function indicator, GFR, remained stable. Because the nephron number does not increase as adults gain weight, increased body weight and body size merely enhance single-nephron loading, which may lead to a loss of GFR over time (Kramer et al. 2005). Furthermore, this outcome provides supporting evidence for early educational intervention in CKD to retard renal function deterioration. In other words, an educational intervention should include a focus on reducing central body fat distribution and BMI to stabilise renal function. Although BMI showed a statistically signicant decrease at the sixth and twelfth month, the average of BMI was still greater than 25 at the end of the follow-up period.

Changes in renal function protection knowledge

A fundamental consideration for delaying the progress of CKD is patient education at the early stage (Devins et al. 2005). Overall knowledge scores increased slightly at the sixth month and decreased at the twelfth month in this study. This indicates that to maintain patients knowledge of renal function protection, use of Chinese herbs and diet, workshops may need to be conducted at least every six months. An important issue with this Taiwanese sample was the use of Chinese herbs. The intervention developed and delivered in this study included content on the use of Chinese herbs, which has seldom been the focus of interventions for people with early stage CKD. It has been shown that many CKD patients in Taiwan use Chinese herbs in the belief that herbs will preserve kidney function (Lin et al. 2005). Two retrospective studies revealed that patients with ESRD had previously used one or more forms of complementary therapy before they received haemodialysis treatment in Taiwan. Complementary therapies used, included traditional Chinese herbs, which were not always reported to health care providers (Chiou 1999, Lin et al. 2005). In Taiwan, many people believe Herbs cannot harm, only cure. Herbs are panacea. Natural things are better than synthetic ones Chinese herb medicines do not give side effects (Dahi 2001, Isnard et al. 2005). However, the effects of herbal medicine are controversial; their use may harm the kidney itself. Study participants expressed that all Chinese herbs were safe, warm, nourishing. Thus, people may not use them carefully with physicians prescriptions. Our ndings highlight that although herb medicine may have many

Changes in body composition

Obesity is believed to be associated with renal damage (Iseki et al. 2004). A body of research demonstrates that central fat distribution may be more salient to the problem of renal damage than general obesity. One study revealed that GFR decreases linearly with the increase of the WHR ratio after adjusting for confounding factors (Pinto-Sietsma et al. 2003). In Okinawa, Japan, a study on a group of over 100,000 individuals identied that obesity was a major risk factor for the development of CKD and the degree of obesity also predicted the progression to end-stage renal disease (ESRD) (Iseki et al. 2004). Similarly, a cohort study with follow-ups
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advantages, health professionals have to be very careful in evaluating the patients reliance and use of it. The misuse of herbs may lead to a decreased of GFR or even directly to a nephrotoxic state (Dahi 2001). In Taiwanese culture, many people use Chinese herbs for restorative preparations and to build up physical strength (Teng et al. 1995). Furthermore, because Chinese herbs are perceived as natural foods for daily use, patients with CKD may not recognise Chinese herbs as medicines and thus not report their use during a medication history. The use of Chinese herbs and culturally appropriate lifestyle interventions need attention in future research.

we wanted all participants to receive an educational intervention.

Conclusion
Early predialysis educational interventions are recommended to slow the progression of CKD. Although the participants in this study were older than those in previous studies average renal function remained stable during the one-year follow-up period, indicating that the educational intervention may have had some success in retarding deterioration of renal function. The intervention may also improve knowledge related to renal function protection and perceptions of general physical health. This study reports that overall knowledge scores (renal function protection, Chinese herbs and diet) showed signicant differences between the baseline, sixth and twelfth month follow-up. Knowledge of use of Chinese herbs and diet domains increased at the sixth month then decreased at the twelfth month, while the renal function protection domain showed no change over time. This study provides evidence that Taiwanese CKD patients routinely use Chinese herbs and may not report their use to health care providers or understand possible adverse effects on renal function. Education for early-stage CKD patients should incorporate more traditional, culturally specic diet information and emphasise content on traditional Chinese herbs for patients likely to use alternative therapies. Finally, overall QOL scores in this study decreased at the twelfth month follow-up, despite stable renal function.

Changes in quality of life

Health status may inuence ones perception of QOL (SuetChing 2001). In this study, participants in the early stage of CKD may not yet experience or be aware of CKD symptoms. Perceived overall health in our study was high compared with haemodialysis patients (Sesso & Yoshihiro 1997). Although we found that overall satisfaction with health status reported by CKD patients did improve over time, we suspect that the improvement might not reect the true improvement of health status but rather could be an intervention effect. Research indicates that when GFR is below 30 ml/minutes/ 173m2, symptoms associated with uraemia, such as lack of energy or fatigue, may appear (Patel et al. 2002). These symptoms may affect peoples QOL (Sesso & Yoshihiro 1997). The average GFR for the studied participants was 41 ml/minutes/173m2. QOL measured overall and through four subdimensions, was signicantly higher in this study than other ones where patients kidney function was lower (Jang et al. 2004, Perlman et al. 2005, Yang et al. 2005). However, the scores for overall QOL in this study decreased at the twelfth month follow-up although GFR levels remained stable. It is possible that post intervention lifestyle adjustments, such as changes in diet, may have affected perceptions of QOL.

Acknowledgements
This study was funded by National Science Council, Taiwan (NSC92-2314-B-006-097). We would like to thank the patients with CKD who participated in this study and Blair G. Darney for editorial assistance.

Contributions
Limitations
This study must be interpreted with limitations in mind. Generalisability of the study ndings may be restricted due to the small sample size and selection bias. It is possible that participants might have better health and higher motivation to learn health promotion activities than those who did not participate. The one-group design also limits drawing conclusions about the effects of the educational intervention. However, current recommendations emphasise early intervention. This study used a one-group design with repeated measurements over 12 months; for ethical reasons, Study design: MY, J-JH; data collection and analysis: MY, J-JH, H-LT and manuscript preparation: MY, J-JH, H-LT.

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