J Nephrol
DOI 10.1007/s40620-014-0144-2

ORIGINAL ARTICLE

Efficacy of a disease management program focused on acquisitionof self-management skills in pre-dialysis patients with diabetic
nephropathy: 24 months follow-up
Kana Kazawa • Yae Takeshita • Noriaki Yorioka •Michiko Moriyama

Received: 9 May 2014 / Accepted: 11 September 2014
Ó Italian Society of Nephrology 2014

Abstract
Purpose We previously performed a preliminary 6-monthcontrolled trial to examine the effect of a disease management education program on prolongation of the time torenal replacement therapy (RRT) and/or avoidance of RRT
for patients with diabetic nephropathy. However, its duration was too short to follow the changes of renal function,so we performed the present study for 24 months.
Methods This was a two-group comparative study. Theintervention group received self-management educationfrom disease management nurses and was supported by thenurses in cooperation with their primary physicians for
12 months. Then this group was followed for a further
12 months. The control group received standard care andwas followed for 24 months.
Results Of the 31 subjects enrolled in each group, 26
subjects in the intervention group and 27 subjects in thecontrol group were analyzed after excluding drop-outs.
During the study period, 0 and 2 subjects in the intervention and the control group started RRT, respectively. In theintervention group, renal function was maintained, while
significant worsening was observed in the control group.
K. Kazawa (&)  M. Moriyama
Division of Nursing Science, Institute of Biomedical and Health
Sciences, Hiroshima University, Kasumi 1-2-3 Minami-Ku,
Hiroshima 734-8553, Japane-mail: kanak1016@gmail.com
Y. Takeshita
Division of Nursing Science, Graduate School of Biomedicaland Health Sciences, Hiroshima University, Kasumi 1-2-3
Minami-Ku, Hiroshima 734-8553, Japan
N. Yorioka
Hiroshima Kidney Organization, Yanoshinmachi 2-2-19 Aki-Ku,
Hiroshima 736-0084, Japan

Hemoglobin A1c (HbA1c) improved in the intervention
group, but became significantly worse in the control group.
In the intervention group, all process indicators of behavior
modification increased significantly after intervention.
Conclusion A well-designed disease management program might be useful for maintaining renal function andimproving HbA1c in patients with diabetic nephropathy. It
is considered that modification of patient behavior contributed to these results.
Keywords Diabetic nephropathy  Patient education 
Self management  Disease management

Introduction
In recent years, there has been an increase worldwide inpatients with diabetic nephropathy requiring renal
replacement therapy (RRT) [1–4], which has led to thecurrent situation of declining quality of life (QOL) andincreasing healthcare costs [5, 6]. A similar situation exists
in Japan [7, 8].
Background healthcare issues also exist in Japan, in
addition to lifestyle changes. First, the importance ofnephropathy management is often overlooked, and patients
may only see a nephrologist for the first time when theyneed RRT [9]. Early referral to a nephrologist and appropriate treatment could prolong the period before initiationof RRT, as well as improving the prognosis and reducing
hospitalization and healthcare costs [10]. Second, appropriate management for staging diabetic nephropathy
according to evidence-based clinical guidelines is very
important [11, 12], but patient education has not kept pacewith the rise in diabetic nephropathy [9]. To solve theseissues, cooperation of medical institutions and training of123

J NephrolFig. 1 Disease management program outline

nurses and dietitians to provide care are required [9].
Therefore, we focused on disease management. This is asystem of coordinated health care interventions and communications for patients with conditions for which patient
self-care can be significant. It supports communication
between the physician and patient, which promotes
appropriate medical treatment and patient education basedon clinical guidelines [13]. We performed two preliminary
studies for 6 months by (1) extracting patients withadvanced diabetic nephropathy, (2) setting up a disease
management center, and (3) providing nurses with specialized training as disease management nurses to support
physicians and patients [14, 15]. After 6 months, patients
who received our intervention showed a significant
increase of adherence to medication/insulin therapy andself-monitoring behavior, which led to improvement ofhemoglobin A1c (HbA1c). In addition, serum creatinine(Scr) levels and estimated glomerular filtration rate (eGFR)
were maintained. Unfortunately, the duration of thesestudies was too short to follow the changes of renal function. Furthermore, in patients with diabetic nephropathy,
several studies have shown that intensive treatment aimed
at lifestyle improvement, in addition to diet, medication,and exercise, can improve clinical indicators [16, 17].
However, those studies did not include a structured program based on behavior modification theory, which we
consider highly important for managing and educating thehuge number of patients with diabetic nephropathy in a123

reproducible, high quality, and cost-effective manner.
Accordingly, we performed this two-group comparative
study for 24 months to investigate the effect of a disease
management education program based on behavior modification theory for patients with diabetic nephropathy,
following the hypotheses described in Fig. 1.

Methods
Subjects
The subjects were adult patients aged between 53 and72 years with type 2 diabetic nephropathy attending any of
the 20 hospitals or clinics in Kure city and Hiroshima city,
Japan. Inclusion criteria were an eGFR between 15–59 ml/
min/1.73 m2 and age from 20 to 74 years. Exclusion criteria were current RRT, cognitively impaired or mental
disorders, or pregnancy.
Study design and sample size
This study was performed from March 2010 to December
2012. It was a non-randomized, controlled trial comparing
patients who underwent a disease management program
conducted by nurses with other patients who received
conventional treatment. Sample size was determined byKure City medical insurance staff based on their budget.

J Nephrol

Recruitment and registration
Intervention group: Kure City medical insurance staff
identified all insured persons with diabetic nephropathy as
their current diagnosis. After their primary physicians
confirmed whether they met the study criteria, we asked
them to participate.
Control group: After selecting the intervention group,
the control group (non-intervention) was selected from
hospitals in Kure and Hiroshima in such a way that itmatched the intervention group for baseline.
Disease management program for the interventiongroup
The objective of this program was for the subjects toacquire self-management skills (Fig. 1). Prochaska et al.
[18] stated that behavior modification is maintained if themodified behavior persists after 6 months of fulfilment of
the program. To provide skills for managing seasonal
events, we set the duration of the program at 12 months.
Subject education was conducted via face-to-face interviews every 2 weeks from enrollment to the end of month
2 at the subject’s home or at a collaborating research centerand phone calls every month from month 3 to 12. Eachsubject was always assigned to the same nurse to allowbuilding of a relationship between them and for continuityof care. Education focused on diet, drug therapy, andexercise/rest balance, etc. (see Table 1). Original materials
Table 1 Contents of education
Diet
Reduced salt intake (\6 g/day)
Low protein (0.8 g/kg/day)Appropriate energy intake (27–30 kcal/kg/day)
Restriction of K and P based on laboratory data.
Drug therapy
Medication complied with the instructions of physicians andclinical guidelines
Method of insulin inject
Exercise
Exercise/rest balance based on their CKD stages
Aerobic exercise, Strech, Mascle training
Alcohole intake
Amount of pure alcohol a day less than 20 g, it is allowed byphysicianSmoking cessation
Preventing infection and sick day ruleStress management
Self-monitoring
Blood pressure, body weight, blood glucose, symptoms, footsensory checkused for education included booklets created by the
researchers (authors) based on evidence-based clinicalguidelines for chronic kidney disease (CKD) and for diabetes [19, 20], and on an ethnographical field study weperformed in order to identify patients’ viewpoints on selfmanagement and the expert opinions of nephrologists andendocrinologists. The text included explanations andillustrations of disease mechanisms, methods for selfmonitoring of symptoms, blood pressure, blood glucose,and body weight, and the method of foot care. There werealso photographs to provide assistance in choosing foods
and making decisions about menus for self-management.
The program aimed at the acquisition of knowledge andskills that patients could use, and we supported them toincrease their adherence and enhance the efficacy of selfmanagement [21]. This program incorporated several
behavior modification theories such as the transtheoreticalmodel [18], motivation interviewing method, and social
support theory. In cooperation with the primary care physician, target values of blood pressure, weight, and laboratory parameters were verified, as well as instructions fordiet and exercise. Physicians received monthly progress
reports from the nurses, while abnormal data or symptoms
were reported immediately.
Control group (non-intervention)
Subjects received on a monthly basis usual care. After
registration, they completed and sent questionnaires to us
and we collected laboratory data from their medical records
periodically during the 24-month study period.
Quality assurance
In this study, trained nurses had the main role in patient
education, but were supported by a consultation system that
had been previously established by them to form a therapeutic alliance with nephrologists, endocrinologists, andregistered dietitians [22]. In order to ensure the quality ofpatient education, the intervention protocol was designed
so that five disease management nurses who possessedknowledge and skills with regard to patient education could
carry out the intervention. Before intervention, the researchnurses received training on methods to control diabetic
nephropathy, and knowledge and skills related to disease
management and patient education such as disease mechanisms, treatment, diet, drug therapy, exercise, and stressmanagement. The research nurses also received lectures on
the methods of supporting behavior modification and performed role play exercises. Furthermore, they learned
about teamwork with doctors and registered dietitians.
During the program, the treatment and education of eachpatient was assessed regularly based on the clinical practice123J Nephrol

psychological indicators: the Self-Efficacy Scale of HealthBehavior in Patients with Chronic Disease [23], and theWorld Health Organization Quality of Life (WHO-QOL26)
scale, Japanese version [24]; (3) process indicators: thepercentage of days per month that subjects performed thefollowing self-management behaviors (dietary and exercise
target behaviors, i.e. self-monitoring of blood pressure,body weight, and blood glucose levels; and medication
complying with the instructions of their physician).
eGFR was calculated as follows: eGFR (ml/min/
1.73 m2) = 194 9 Scr-1.094 9 age-0.287 (9 0.739 forfemales) (Japanese Society of Nephrology, JSN) [19]. Non
HDL-c (mg/dl) was calculated as total cholesterol–highdensity lipoprotein cholesterol. Furthermore, we obtained
and collected scores according to the following scale:\300 mg/g Cr (0 points), C300 and \1 g/g Cr (1 point),
C1 and \ 3 g/g Cr (2 points), and C3 g/g Cr (3 points).

guidelines, and the nurses received advice from nephrologists, endocrinologists, or registered dietitians when necessary, and discussed issues with them. The research nurses
provided education for the patients and discussed treatment
details with the attending doctors to support the optimization of treatment.
Data collection
During the 12-month intervention period, renal function
indicators (Scr, eGFR) and process indicators for behavioral modification were collected every three months, whiledata on other variables were collected every 6 months, inboth groups. To investigate the effect on primary outcomes, subjects were also followed for 24 months.
Primary and secondary endpoints
The primary endpoint was the number of patients who
initiated RRT. Secondary endpoints comprised (1) physiological indicators: HbA1c (National Glycohemoglobin
Standardization Program, NGSP), Scr, eGFR, blood urea
nitrogen (BUN), hemoglobin (Hgb), total protein (TP),albumin (Alb), potassium (K), inorganic phosphate (P), nonhigh-density lipoprotein cholesterol (non HDL-c), bloodpressure, body mass index (BMI), and urine protein; (2)Table 2 Comparison of
baselines

SCr serum creatinine, eGFR
estimated glomerular
filtrationrate, BUN blood urea
nitrogen, Hgb hemoglobin,
HbA1c hemoglobin A1c, TP
total protein
Alb albumin, K potassium,
P inorganic phosphate, non
HDL-c non high-density
lipoprotein cholesterol, BMI
body mass index
a t test, b x2test, c Mann–
Whitney U testa
QOL score 0–5 points, with ahigher score indicating higher
QOLb

Self-efficacy score 0–96
points, with a higher scoreindicating greater self-efficacy* p \ 0.05

123

Statistical analysis
To compare two groups, repeated-measures two-way factorial analysis of variance was performed on variables forwhich a normal distribution was confirmed. When normality was not confirmed, Friedman’s test was performed.
About process indicators, Friedman’s test was also used.
Significance was set at p \ 0.05.
Intervention group

Control groupnn

Mean ± SD

p value

Statistical
test

Mean ± SD

Age

3166.9 ± 4.3

3164.1 ± 5.8

0.035*aSex

31

20 men/11
women

31

20 men/11
women

0.288

b

Disease duration of diabetes(year)

31

14.5 ± 8.9

2815.5 ± 11.1

0.733

a

Scr (mg/dl)

31

1.55 ± 0.50

31

1.64 ± 0.68

0.574

a

eGFR (ml/min/1.73 m2)

31

36.1 ± 12.8

3136.8 ± 13.9

0.826

a

BUN (mg/dl)

3130.3 ± 12.5

31

27.1 ± 12.9

0.321

a

Hgb (mg/dl)

31

12.3 ± 2.0

3112.3 ± 1.9

0.934

a

HbA1c (%)

31

7.3 ± 1.431

7.8 ± 1.1

0.125

a

TP (g/dl)

31

7.1 ± 0.829

7.2 ± 0.5

0.661

a

Alb (g/dl)

31

4.1 ± 0.629

4.3 ± 0.4

0.218

a

K (mEq/l)30

4.7 ± 0.629

4.5 ± 0.5

0.458

a

P (mg/dl)

29

3.5 ± 0.626

3.7 ± 0.6

0.481

a

non HDL-c (mg/dl)

27

123.6 ± 28.3

29123.7 ± 36.7

0.989

a

Systolic blood pressure (mmHg)

31131.9 ± 16.4

31

131.6 ± 17.4

0.934

a

Diastolic blood pressure(mmHg)

31

71.6 ± 11.2

31

70.8 ± 11.9

0.776

a

BMI

31

25.6 ± 4.53025.0 ± 4.9

0.602

a

Urine protein

31

0.9 ± 1.131

1.2 ± 1.3

0.249

c

QOLa

30

3.34 ± 0.4730

3.06 ± 0.42

0.017*

a30

76.3 ± 10.030

75.4 ± 10.5

0.725

a

Self-efficacyb

J NephrolFig. 2 Subjects of this study

Results
Outcomes and initiation of dialysis
We enrolled 31 patients in the intervention group and 31
patients in the control group. At baseline, only age(p = 0.035) and QOL (p = 0.017) showed a significant
difference (Table 2). As for CKD stages, there were no
significant differences in CKD stage G3 (intervention/
control: 20 patients/19 patients), and CKD stage G4(intervention/control: 11 patients/12 patients).
During the 24-month study period, one patient fromeach group died of heart failure in the 15th month(eGFR at enrollment: 21.5 and 16.1, respectively). No
patient in the intervention group commenced dialysis,
while two patients in the control group started dialysis
after 18 and 21 months (eGFR at enrollment was 27.4
and 25.3, respectively). As risk factors associated withworsening of renal function, one patient had a urine
protein level higher than 1 g/Cr and poorly controlled
hypertension, while the other patient had a urine protein
level higher than 1 g/Cr. A total of five patients in theintervention group and four patients in the control group
dropped out (Fig. 2).
Medication usage: the numbers of patients taking medications at the time of enrollment did not differ between thetwo groups (renin angiotensin [RA] system inhibitors,
erythropoiesis stimulating agents, insulin, oral hypoglycemic agents, lipid-lowering agents, hyperkalemia improving
drugs, and oral adsorbents).
Changes of physiological indicators
Analysis of changes over 24 months was performed in 26
patients of the intervention group and 27 of the control
group, excluding patients who died, initiated dialysis, or
dropped out. There were no significant differences ofbaseline factors between the drop-outs and the analyzed

patients. For each indicator, we analyzed changes in bothgroups, excluding patients with missing values (Table 3).
1.

2.

3.

4.

Changes of renal function and related data: Scr andeGFR remained at baseline levels in the intervention
group. On the other hand, Scr showed a significant
increasing and eGFR a significant decreasing trend in
the control group (Fig. 3). Despite the low protein dietof the intervention group, mean BUN values showed
no difference and there were no changes over time ineither group. Hgb remained at the baseline value inboth groups. With respect to urine protein, theintervention group showed a slight decrease, although
the standard deviation was large in both groups andthere were large individual variations. TP showed nosignificant in interaction, but showed significant intergroup variance. Mean values of TP were stable overtime. Mean values of Alb, K, and P were stable overtime, showing no significant differences.
Changes of blood pressure: Blood pressure was stablein both groups over time, with no significant
differences.
Changes of glucose metabolism: In the control group,
HbA1c showed significant worsening 6 months after
enrollment (p \ 0.01), but thereafter remained stablefrom 12 to 24 months. In the intervention group, adecrease of HbA1c was observed, although it was not
significant.
Changes of non HDL-c and BMI: Non HDL-c showedno significant interaction, but a significant in intergroup difference. Mean values of non HDL-c werestable over time. BMI showed no significant changes.

Changes of psychological indicators
In the intervention group, both QOL and Self-efficacy
increased after 6 months, but gradually decreased thereafter, reaching levels equal to those observed at the time of

123

123

1.59 ± 0.52

1.57 ± 0.63

22

21

27

Control

123 ± 37

119 ± 29

3.7 ± 0.6

3.6 ± 0.6

4.6 ± 0.6

4.6 ± 0.5

4.3 ± 0.4

4.2 ± 0.3

7.2 ± 0.5

7.1 ± 0.6

130.5 ± 17.6

131.7 ± 18.3

Intervention

20

71.3 ± 11.7

Diastolic blood pressure (mmHg)

2027Intervention

Control

Systolic blood pressure (mmHg)

18Intervention

non HDL-c (mg/dl)

1022Intervention

26

Control

P (mg/dl)

Control

K (mEq/l)Intervention

21

24

Intervention

Control

Alb (g/dl)

22

7.9 ± 1.1

27

Control

7.2 ± 1.4

Intervention

TP (g/dl)

ControlIntervention

12.3 ± 2.1

12.3 ± 2.0

232326.2 ± 12.3

26

27

30.1 ± 13.3

Intervention

HbA1c (%)

36.1 ± 13.6

37.6 ± 13.4

24

Control

Hgb (mg/dl)

Control

BUN (mg/dl)
Intervention

24

27

Intervention

Control

18 M

24 M

1.58 ± 0.53

1.61 ± 0.64

70.0 ± 11.3

129.7 ± 17.1

66.7 ± 9.1

132.0 ± 16.5

128.5 ± 14.8

114 ± 38

121 ± 27128.5 ± 15.9

131 ± 37

3.5 ± 0.6

3.8 ± 0.8

4.5 ± 0.5

4.6 ± 0.3

4.2 ± 0.5

4.1 ± 0.4

7.0 ± 0.5

7.0 ± 0.5

7.5 ± 1.2

6.8 ± 1.1

12.2 ± 1.8

12.3 ± 2.3

26.6 ± 11.5

30.2 ± 15.0

36.8 ± 16.5

36.2 ± 13.8

1.76 ± 0.98

124 ± 34

3.4 ± 0.8

3.6 ± 0.5

4.4 ± 0.5

4.6 ± 0.5

4.2 ± 0.5

4.2 ± 0.4

7.1 ± 0.5

7.1 ± 0.7

8.3 ± 1.6

6.8 ± 0.8

12.3 ± 1.7

12.5 ± 2.2

28.2 ± 15.1

30.4 ± 11.2

39.6 ± 18.1

37.2 ± 14.6

1.68 ± 1.04

1.65 ± 0.63

69.2 ± 8.6

128.2 ± 20.6

130.4 ± 15.9

107 ± 32

117 ± 32

3.5 ± 0.8

3.6 ± 0.5

4.6 ± 0.6

4.6 ± 0.5

4.1 ± 0.4

4.1 ± 0.4

6.9 ± 0.5

7.0 ± 0.5

7.7 ± 1.2

7.0 ± 1.4

12.4 ± 1.6

12.6 ± 2.0

28.2 ± 14.1

31.4 ± 13.5

34.2 ± 18.0

36.2 ± 15.0

1.92 ± 1.30

1.76 ± 0.82

68.0 ± 8.5

130.0 ± 22.3

125.1 ± 12.0

110 ± 36111 ± 35

3.7 ± 0.8

3.8 ± 0.5

4.5 ± 0.5

4.6 ± 0.5

4.2 ± 0.4

4.1 ± 0.4

7.1 ± 0.5

7.0 ± 0.6

7.6 ± 1.1

6.7 ± 0.6

12.2 ± 1.7

12.4 ± 1.9

31.3 ± 19.4

33.5 ± 15.0

32.0 ± 17.9

34.5 ± 14.8

2.23 ± 1.71

0.309

0.406

0.702

0.547

0.107

1.933

0.491

0.859

0.587

0.709

0.567

0.739

0.542

0.745

0.819

0.019

0.666

0.189

0.569

0.329

0.652

0.208

0.379

0.788

0.364

0.840

0.969

0.002

0.789

0.073

Intra-qorup

1.473

0.726

0.513

0.003**

4.238

0.353

1.114

0.599

0.692

0.072

2.191

0.015*

3.437

0.521

0.754

Inter-group

Interaction

12 M

BL

6M

Two-way repeted measures of ANOVA (top: F value, bottom: p value)

Changes over timeeGFR (ml/min/1.73 m2)

24

27

Intervention

Control

Scr (mg/dl)nTable 3 Changes in physiological indicators

0.001**

0.051

0.408

0.274

0.000***

0.754

0.000***

0.689

p valueFriedman’s test

J Nephrol24 months after enrollment. In the control group, QOL did
not change and Self-efficacy was decreased at 24 months(Table 4).
Changes of process indicators
The achievement rate of behavioral goals was assessed in
the intervention group (Fig. 4). Behavioral goals for diet,
activity, and rest all improved significantly after intervention (p \ 0.05). Self-monitoring and compliance withmedication increased significantly after intervention(p \ 0.01).

Discussion* p \0.05, ** p \ 0.01, *** p \ 0.001

SCr serum creatinine, eGFR estimated glomerular filtrationrate, BUN blood urea nitrogen, Hgb hemoglobin, HbA1c hemoglobin A1c, TP total protein, Alb albumin, K potassium, P inorganic
phosphate, non HDL-c non high-density lipoprotein cholesterol, BMI body mass index, BL baseline, 6 M post 6 month, 12 M post 12 month, 18 M post 18 month, 24 M post 24 month

0.813

0.299
0.061

0.805
0.326

1.161
24.9 ± 4.3

25.4 ± 4.9
25.2 ± 4.8

25.3 ± 4.5
25.0 ± 4.4

25.3 ± 5.0
25.7 ± 4.8

25.0 ± 4.5
25.1 ± 4.4
2027Intervention

Control

BMI

1.0 ± 1.2

0.8 ± 1.0
1.0 ± 1.1

1.2 ± 1.3
1.3 ± 1.2

0.9 ± 1.0
1.1 ± 1.1

1.0 ± 1.3
1.2 ± 1.3

1.1 ± 1.2

925

Intervention

Control

25.3 ± 5.0

0.320
0.212
0.890
0.804
68.5 ± 13.2
67.9 ± 12.3
69.3 ± 10.3
70.4 ± 12.6
70.9 ± 12.7
27
Control

Urine protein

Intra-qorup
24 M
18 M
6M

12 M
n

Table 3 continued

0.252

p value
Interaction
BLInter-group

Two-way repeted measures of ANOVA (top: F value, bottom: p value)
Changes over timeFriedman’s test

J Nephrol

Diabetic nephropathy requires complex management ofnephropathy and diabetes and patients need to keep
acquiring complex self-management skills. The effects of amultifactorial intervention on prevention of the progression of diabetic nephropathy were previously assessed by
the Steno-2 study [16, 25]. However, the study targeted
early stages and there was no structural program based on
behavior modification theories. With respect to systematic
reviews of the effects of educational programs on patientswith diabetic nephropathy, one randomized controlled trial(RCT) for dialysis patients and one cohort study forpatients at early stages of disease have been reported. The
latter study performed psychological educational programs: effects were observed on patient knowledge andprolongation of the time to RRT [26]. Therefore, further
research was required to perform the education program
based on behavior modification theories and report on theacquisition of self-management behavior, physiologicalindicators, and even transition to dialysis in patients at
advanced stages.
In this study, we performed an intervention on patientswith advanced diabetic nephropathy. The results indicatethat our structured disease management program based on
behavior modification theory supports the acquisition ofself-management knowledge and skills by patients. In theintervention group, patients changed their lifestyle toimprove their renal function and tried hard to achieve their
behavioral goals every month. They also communicatedwell with their primary physicians by bringing their selfmonitoring data to appointments. To teach patients how tohandle seasonal events which often lead to loss of selfcontrol, a 12-months program worked well. The results
partially support our hypothesis that education provided bynurses combined with setting of feasible monthly goals andfeedback can significantly improve patient behavior andmaintain self-efficacy. As for the reasons why self-efficacy
was maintained in the intervention group, it can be123J NephrolFig. 3 Changes in eGFR

Fig. 4 Changes in process
indicators

mentioned that the nurses provided psychological support
for the subjects along with the behavior modification. In
addition, the target behavior implementation rate was visualized in the process of behavior modification, and nurses
evaluated the results positively. It is thought that adherence
to self-management with maintenance of self-efficacy
resulted in an improved lifestyle. In addition, maintenance ofmodified behavior improved HbA1c and maintained renal

123

function, with no patient requiring RRT in the intervention
group. Although prolongation of the time to introduction of
RRT was achieved, there were no significant changes of selfefficacy, QOL, and some physiological data. With respect toself-efficacy, the intervention group showed improvement at
6 months after nurse-patient communication started, and thelevel was maintained thereafter. In the non-intervention
group, however, the level of self-efficacy was lower afterJ Nephrol
Table 4 Changes in phychological indicatorsnChanges over time

BL

6M

12M

18M

24M

Two-way repeted measures of
ANOVA (top: F value, bottom:
p value)Friedman’s
test

Interaction

p value

Intragorup

Intergroup

QOLa
Intervention

19

3.35 ± 0.40

3.44 ± 0.33

3.27 ± 0.40

3.24 ± 0.43

3.29 ± 0.46

0.180

Control

24

3.08 ± 0.43

3.01 ± 0.42

3.04 ± 0.44

3.07 ± 0.48

3.05 ± 0.44

0.932Intervention

19

78.2 ± 9.2

82.2 ± 8.4

77.4 ± 9.8

77.5 ±11.2

78.2 ± 10.4

4.167

4.097

0.729

Control

2475.5 ± 10.2

70.8 ±11.4

73.4 ± 10.0

73.2 ± 9.6

72.8 ± 10.3

0.289

0.003**

0.573

Self-efficacyb

BL baseline, 6 M post 6 month, 12 M post 12 month, 18 M post 18 month, 24 M post 24 montha

QOL score 0–5 points, with a higher score indicating higher QOLb

Self-efficacy score 0–96 points, with a higher score indicating greater self-efficacy** p \ 0.01

24 months than at enrollment. Diabetic nephropathy
requires complex treatment, so effective self-management isonly possible with education provided over a sufficientperiod of time. The results in the intervention group werelikely obtained due to the effects of the intervention by disease management nurses, which helped improve self-management skills and enabled maintenance of self-efficacy.
On the other hand, two patients initiated RRT in thecontrol group and significant worsening of renal function
was observed. The rate of GFR decline in this stage ofdiabetic nephropathy was reported to be -2*20 ml/min/
1.73 m2/year [27]. Although the results were only for a
24-month period, maintenance of renal function andavoidance of RRT were achieved by cooperation withdisease management nurses, even when the patient’s physician was not a specialist. However, death due to heart
failure was reported at 15 months in both groups, suggesting that management of heart failure should have been
included in the program with measures such as strict
weight control. It is also suggested that research nurses
may need to acquire knowledge and skills about the management of cardiovascular disease. In other words, not only
collaboration with nephrologists and endocrinologists, butalso with cardiologists may be necessary because management of patients with severe complications is complex.
This is an important consideration in the care of patientswith end-stage renal failure.
Disease management aims to provide high quality
health care that is appropriate for the patient’s disease andrisk factors, based on multidisciplinary collaboration.
However, the family doctor, specialist physicians, nurse
specialists, and registered dietitians do not belong to one
institution. In such a situation, the most appropriate selfmanagement strategy for the patients and how they canaccess each expert are unclear. We believe that the nurse
is the most appropriate person to provide connections
between multidisciplinary health care workers andpatients in order to improve the quality of health care.
Even though the attending physicians of the subjects were
not nephrologists, appropriate management was implemented with the support of trained disease management
nurses, resulting in prolongation of the time to RRT,
reduction of hospitalization by avoiding emergency hemodialysis, and avoidance of RRT. Since these outcomes
all led to a reduction of healthcare costs, this study suggests that this program run by nurses could be highly
cost-effective.
However, there was a limitation to this study. In order toobtain a significant difference of the primary endpoint, we
needed 80 patients per group (sample size). In the future, itwill be necessary to confirm our findings by performing arandomized study on a larger scale.
Acknowledgments We would like to express our deepest gratitude
to the Kure City medical insurance staff who provided the field forthis study. We are also indebted to the disease management nurses fortheir support.
Conflict of interest The authors declare that they have no conflictsof interest.
Ethical standards Approval was obtained from the ethics committees of Hiroshima University Hospital and the participating medical institutions. All subjects gave written consent to participation andthe study was performed according to the Declaration of Helsinki.

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