Baseline Feature of a Randomized Trial Assessing the Effectsof Disease Management Programs for the Preventionof Recurrent Ischemic Stroke
Yasuko Fukuoka, RN, PHN, MSN,* Naohisa Hosomi, MD, PhD,†
Takeshi Hyakuta, RN, PhD,‡ Toyonori Omori, MD, MPH, PhD,x Yasuhiro Ito, MD, PhD,jj
Jyunichi Uemura, MD, PhD,{ Kazumi Kimura, MD, PhD,{
Masayasu Matsumoto, MD, PhD,† Michiko Moriyama, RN, PhD,#
and DMP Stroke Trial Investigators

Background: Comprehensive and long-term patient education programs designed to
improve self-management can help patients better manage their medical condition.
Using disease management programs (DMPs) that were created for each of the risk
factor according to clinical practice guidelines, we evaluate their influence on theprevention of stroke recurrence. Methods: This is a randomized study conductedwith ischemic stroke patients within 1 year from their onset. Subjects in theintervention group received a 6-month DMPs that included self-management
education provided by a nurse along with support in collaboration with the primarycare physician. Those in the usual care group received ordinary outpatient care.
The primary end points are stroke recurrence and stroke death. Patients were enrolled
for 2 years with plans for a 2-year follow-up after the 6-month education period (totalof 30 months). Results: A total of 321 eligible subjects (average age, 67.3 years; females,
96 [29.9%]), including 21 subjects (6.5%) with transient ischemic attack, were enrolled
in this study. Regarding risk factors for stroke, 260 subjects (81.0%) had hypertension,
249 subjects (77.6%) had dyslipidemia, 102 subjects (31.8%) had diabetes mellitus, 47
subjects (14.6%) had atrial fibrillation, and 98 subjects (30.5%) had chronic kidney disease. There were no significant differences between the 2 groups with respect to subject characteristics. Conclusions: This article describes the rationale, design, andbaseline features of a randomized controlled trial that aimed to assess the effects of
DMPs for the secondary prevention of stroke. Subject follow-up is in progress andwill end in 2015. Key Words: Stroke—disease management programs—selfmanagement—prevention of recurrence—primary care setting—risk factor control.
Ó 2015 by National Stroke Association

From the *Division of Nursing Science, Graduate School of
Biomedical and Health Sciences, Hiroshima University, Hiroshima;†Department of Clinical Neuroscience and Therapeutics, Graduate
School of Biomedical and Health Sciences, Hiroshima University,
Hiroshima; ‡Faculty of Nursing, Japanese Red Cross Hiroshima
College of Nursing, Hiroshima; xNational Institute of Health andNutrition, Tokyo; jjDepartment of Neurology, TOYOTA Memorial
Hospital, Toyota; {Department of Stroke Medicine, Kawasaki
Medical School Hospital, Kurashiki; and #Division of Nursing
Science, Institute of Biomedical and Health Sciences, Hiroshima
University, Hiroshima, Japan.
Received September 29, 2014; revision received October 14, 2014;
accepted October 16, 2014.

This study was initially supported by the Ministry of Health, Labourand Welfare, Japan. K.K. received speakers’ bureau from Mitsubishi Tanabe Pharma Corporation, Otsuka Pharmaceutical Company Limited,
and Boehringer Ingelheim Japan Incorporated. M.M. is a chairpersonof DPP Health Partners Company Limited and received cooperative
research fund. The other authors declare no conflicts of interest.
Address correspondence to Yasuko Fukuoka, RN, PHN, MSN,
Department of Nursing Science, Graduate School of Biomedicaland Health Sciences, Hiroshima University, Hiroshima, Japan,
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, Japan. E-mail:yasukofukuoka@hotmail.com.
1052-3057/$ - see front matterÓ 2015 by National Stroke Association
http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2014.10.007

Journal of Stroke and Cerebrovascular Diseases, Vol. -, No. - (---), 2015: pp 1-8

1

Y. FUKUOKA ET AL.

2

Various types of clinical practice guidelines havebeen created that offer high quality treatments. Thereis a high probability that patients will reduce or
discontinue medications on their own, leading to ahigh risk of stroke recurrence.1 The prevention ofischemic stroke recurrence improves with meticulous
control of the associated risk factors. In addition,
many of the risk factors are associated with lifestyleactivities such improper diet, lack of exercise, smoking,and overconsumption of alcohol. Adequate control ofrisk factors is difficult without lifestyle adjustments.
In patients with coronary artery disease, it has beenshown that positive changes in lifestyle in combination
with medical therapy decrease the mortality rate.2
Patients and their families often do not have enoughinformation regarding risk factors for ischemic stroke
and the available methods of self-management.3
Comprehensive and long-term patient education
programs designed to improve self-management canhelp patients better manage their medical condition ina manner consistent with the guidelines while
addressing their individual risk factors.4
We used disease management programs (DMPs) aimed
at preventing the recurrence of ischemic stroke as a tool
for providing such education. DMPs lead to treatment
optimization, prevention of treatment-related complications, and reduced aggravation of physiologic and psychologic conditions.5 DMPs have been shown to beeffective in preventing the deterioration of diseases andin reducing increases in medical expenses.6,7 In thisDMP Stroke Trial, we used DMPs that were createdfor each risk factor according to clinical practiceguidelines 4,8-12 to evaluate the efficacy of the programin preventing stroke recurrence.
This article describes the rationale, design, and baselinefeatures of a randomized controlled trial aimed at assessing the efficacy of DMPs facilitated by nurses in the prevention of stroke recurrence.

Methods
Trial Design
This is a multicenter, randomized (1:1), open-label,parallel group study conducted in outpatients with aprior history of stroke. The study protocol andinformed consent form were approved by the institutional review board of each center. Written informed
consent for participation was obtained from each patient. In addition, this study is being conducted under
the health insurance system of Japan, in accordancewith the Declaration of Helsinki and the Ethical Guidelines on Clinical Studies of the Ministry of Health,Labour and Welfare of Japan. This study is registered under the following IDs: UMIN000007808 and
NCT02121327.

Study Population
Between September 2010 and November 2012, we
enrolled patients between 40 and 80 years within 1 year
from the onset of ischemic stroke (including transientischemic attack [TIA]). The diagnosis of the stroke subtype was made by the physician as either atherothrombotic or cardioembolic or lacunar or other based on the
National Institute of Neurological Disorders and Stroke
criteria.13
Patients were excluded if they had severe complications or physical symptoms that would hinder theirability to carry out the program content. These were
patients with modified Rankin Scale scores of 4 or moreat discharge or with dementia (scores of #20 of 30 on
the revised Hasegawa’s Dementia Scale14). However, if
a caregiving family member living with the patient could
support management, the patient was included even if
he/she had dementia. Patients were excluded if theyreceived medical care in a medical/nursing care facility.
Additionally, pregnant women and individuals under terminal care were excluded.

Study Setting and Randomization
This study is a randomized controlled trial comparing
the intervention group, members of which underwent
DMPs conducted by nurses, and the usual care group,
members of which received conventional treatment
without DMPs. Because the recurrence rate differs
depending on the subtype of ischemic stroke,15 thesubjects were randomized to either the intervention or
the usual care group after being stratified by ischemic
stroke subtype.
Subsequently, with the objective to prevent recurrencein ischemic stroke patients, the intervention group
received the 6-month DMPs. After completion of theeducational programs, the subjects are followed for
24 months for stroke recurrence monitoring over a totalof 30 months.
At the time of registration, information regarding the
subjects’ baseline characteristics and whether any person
was living with the subject was collected. The diagnostic
criteria for risk factors were as follows: for hypertension,
those who were taking antihypertensives or had a bloodpressure of 140/90 mm Hg or more8; for diabetes
mellitus, those who were taking antidiabetic medications
and/or insulin or had a glycated hemoglobin level of
6.5% or more10; for dyslipidemia, those who were taking
hypolipidemics, had high-density lipoprotein cholesterolless than 40 mg/dL, low-density lipoprotein cholesterol
140 mg/dL or more, or triglyceride 150 mg/dL or more9;
for chronic kidney disease, those with an estimatedglomerular filtration rate less than 60 mL/minute/1.73 m2 (calculated from gender, age, and serum
creatinine)11; for smoking, those with a current smoking
habit (ie, those who smoked within 1 month of

BASELINE FEATURE OF DMP STROKE TRIAL

3

Table 1. Study outcomes
Outcomes

Evaluation

Primary outcomes
Stroke recurrence rate and death due to stroke
Secondary outcomes
Economic indicators
Unplanned consultation and days of hospitalization in conjunction with ischemic
stroke and risk factors
Physiologic indicators
Framingham risk score-general cardiovascular disease 10-year risk, body weight,
body mass index, blood pressure, total cholesterol, HDL cholesterol, LDL
cholesterol, triglycerides, serum creatinine, blood urea nitrogen, HbA1c, blood
glucose, PT-INR (only as necessary)
Psychologic indicators
Self-efficacy scale of health behavior in patients with chronic disease, CES-D, SF-36
Evaluation of self-monitoring and
Evaluated subject frequency of checking blood pressure, taking medicine, following
lifestyle improvement actions
the prescribed diet, and exercising (0, never; 1, once a month; 2, once a week; 3,
2-3 times a week; 4, 4-5 times a week; 5, every day). The quantity and frequencyof alcohol intake and smoking
Abbreviations: CES-D, Center for Epidemiologic Depression Scale; HbA1c, glycated hemoglobin; HDL, high-density lipoprotein; LDL, lowdensity lipoprotein; PT-INR, prothrombin time international ratio; SF-36, 36-item short form.

enrollment); and for excessive drinking, those who
consumed 46 g of pure ethanol or more every day.
Regarding psychologic indicators, the self-efficacy
scale on health behavior in patients with chronic
disease,16 the Center for Epidemiologic Depression
Scale,17 and the Medical Outcomes Study 36-item short
form18 were evaluated at enrollment and were either
completed on-site or collected by mail.

Primary and Secondary Outcomes
The primary end points of this study are recurrence rate
and mortality from stroke. The secondary end points
include an improvement in the indicators listed inTable 1 (eg, economic, physiologic, and psychologic indi-

Figure 1.
tion.

Scheme illustrating the interven-

cators and evaluation of self-monitoring and lifestyle
improvement).

DMP for the Intervention GroupThe intervention was performed based on the scheme
shown in Figure 1. The program objectives were helping
the subject to acquire skills for self-management and thecontrol of ischemic stroke risk factors. The duration of
the education program in this study was 6 months,
which is the minimum duration required for behavior
modification.19
The subjects were educated via interviews and phone
calls (Fig 2). Interviews were conducted a total of 4 times:
twice between registration and the first month of

Y. FUKUOKA ET AL.

4

Figure 2.

Disease management program outline. Abbreviations: CES-D, Center for Epidemiologic Depression Scale; SF-36, 36-item short form.

intervention, once at month 3, and once at month 6 in thesubject’s home or a collaborating medical facility. Phone
calls were made a total of 10 times every 2 weeks.
The intervention supported for self-management anddrug therapy to control subject’s risk factors using 14
types of education booklets created by the researchers
as well as a self-management record notebook in which
the subject recorded daily blood pressure, body weight,
and lifestyle improvement goals (in Appendix). The education booklets used were selected such that they weresuitable for the individual subject.
Nurses worked collaboratively with patients and their
physicians to achieve individualized clinical target values

and self-management goals (Table 2). Abnormalities inself-monitored values or data or the development or
exacerbation of subjective symptoms were reported
immediately to the primary care physician. Appropriate
treatment and therapeutic activities were assessedcollaboratively by the nurses and primary care
physicians and were based on the clinical practiceguidelines.
The details of the intervention are Figure 2.

Education for the Usual Care GroupAt the initial interview, the subjects were given
instructions using a leaflet that consisted of material

BASELINE FEATURE OF DMP STROKE TRIAL

5

Table 2. Goals of risk factor control and self-management
Management goals
Hypertension
Dyslipidemia

Diabetes mellitus

Target value
Systolic blood pressure
Diastolic blood pressure
HDL cholesterol
LDL cholesterol
Triglycerides
HbA1c

Under 140 mm Hg
Under 90 mm Hg
Over 40 mg/dL
Under 140 mg/dL
Under 150 mg/dL
Under 6.5%

Management goals

Performance objectives

Blood pressure measurement

Measure twice daily (in the morning within 30 min of awakening and in theevening at bedtime)
Measure once daily
Comply as prescribed
Proper calories 5 Patient’s ideal body weight (patient BMI 22 kg/m2) 3 degreeof activity (light, 20; heavy, 30)
Upper limit of calories: 2000 kcal, salt intake: #6 g/d
Proper amount of protein intake (in case of chronic kidney disease)
Over 30 min a day, every day if possible, or 180 min a week
Smoking cessation
Amount of alcohol per day is no more than 20 g of pure alcohol

Body weight measurement
Medication
Diet

Exercise
Smoking
Alcohol intake

Abbreviations: BMI, body mass index; HbA1c, glycated hemoglobin; HDL, high-density lipoprotein; LDL, low-density lipoprotein.
To convert values for LDL cholesterol to millimoles per liter, multiply by 0.02586; for HDL cholesterol, multiply by 0.02586; and for triglyceride, multiply by 0.01129. BMI is the weight in kilograms divided by the square of the height in meters.

extracted from the educational booklets. They also
received a self-management record notebook, as
described previously. Otherwise, the patients were
given routine medical consultations as per standardpractice.

Quality Assurance
Each of the 14 types of booklets (in Appendix) used in
the present study covered the contents of the patient’s
education, according to the self-management and lifestyle
recommendations of each of the clinical practice guidelines for stroke4 and the risk factors.8-12 The content was
created based on discussions with neurologists, chronic
disease nurse specialists, and registered dieticians.
To ensure quality, the intervention protocol was createdsuch that 22 research nurses who possessed theknowledge and techniques needed for patient education
could administer the intervention. Before the intervention,
the research nurses were also given information on thevarious methods used to control ischemic stroke andthe risk factors and received training on the different
techniques used in disease management. During theintervention, they conducted twice-monthly conferences
to strategies about subject’s problems with nurses who
specialized in chronic disease and stroke. Treatments
were assessed based on the clinical practiceguidelines.4,8-12 The nurses also received advice fromneurologists or diabetologists as necessary.

Data Collection Schedule
To investigate the effect of the program on outcomes,
the subjects are followed for 2 years after properly
adhering to the program (30 months from enrollment).
Primary outcome and economic indicators are assessed
every 3 months in both groups. Data on stroke recurrenceor death caused by stroke are also confirmed. Furthermore, responses to the self-efficacy, quality of life, anddepression scales as well as blood pressure, body weight,
and blood test results are collected every 6 months.

Sample Size
Based on an annual 10% recurrence rate of stroke(including TIAs) in the usual care group,15 a 60% risk
reduction rate in the intervention group,20 and 2.5 years
of follow-up, the number of subjects required to detect
differences between the intervention group and theusual care group was calculated to be 136 for each group(2-tailed 5% significance level, power level of 80%).
Assuming that 10% of the subjects would be lost tofollow-up, the sample size was set at 152 for each groupand 304 for the 2 groups combined.

Statistical Analysis
The intent-to-treat analysis is used to compare theoutcomes of the intervention and usual care group. To
ensure the comparability of randomized samples, allY. FUKUOKA ET AL.

6baseline indicators at the time of registration wereanalyzed. The data are expressed as the mean 6 standard
deviation or median (minimum-maximum) for thecontinuous variables and as frequencies and percentages
for the discrete variables. The differences in continuous
variables between the groups were examined using
the t test or Mann–Whitney U test. The differences in
categorical variables between the groups were examinedusing the c2 test.
For the primary end point, the cumulative incidence of
events is estimated using the Kaplan–Meier method. The
cumulative incidence curves for the 2 groups arecompared using a log-rank test. The Cox proportional
hazard model is also used to estimate the relative risk
(hazard ratio) and the 95% confidence interval, adjustingfor confounding factors, in which risk reduction is expressed as (12hazard ratio) 3 100%.
For the secondary end point analysis of compliancewith the guidelines, the number of subjects with a systolicblood pressure 140 mm Hg or more,8 low-density lipoprotein cholesterol of 140 mg/dL or more,9 and glycatedhemoglobin of 6.5% or more10 are calculated every

6 months in each group and compared with a c2 test.
Every 6 months data are analyzed with an analysis ofcovariance using baseline data as covariates for the physiologic indicators. The psychologic indicators and theextent to which self-monitoring and lifestyle improvement activities were implemented are analyzed with aMann–Whitney U test.

Results
Of the 562 subjects who met the criteria, 321 consented
to participate in the study (consent rate, 57.1%). The subjects were randomly assigned to the intervention group(n5156) or the usual care group (n 5 165).
The demographic data and subject profile of eachgroup are shown in Table 3. The mean age was 67.3 6
8.5 years, and 16.8% of the subjects had a past history ofstroke. The number of subjects who exhibited primaryrisk factors of ischemic stroke were as follows: 260 subjects (81.0%) had hypertension, 102 subjects (31.8%) had
diabetes mellitus, 249 subjects (77.6%) had dyslipidemia,
47 subjects (14.6%) had atrial fibrillation, and 98 subjects

Table 3. Baseline characteristics and subject profiles
Characteristics
Characteristics
Females, n (%)
Unemployed, n (%)
Marital status: married, n (%)
Living with another person, n (%)
Average age, mean 6 SD, y
Subject profile
Recurrent stroke history, n (%)
Modified Rankin Scale score, median (min-max)
Time to registration from onset, mean 6 SD, d
Hypertension, n (%)
Diabetes mellitus, n (%)
Dyslipidemia, n (%)
Atrial fibrillation, n (%)
Chronic kidney disease, n (%)
Alcohol intake, n (%)
Smoking, n (%)
Subtype, n (%)
Atherothrombotic
Cardioembolic
Lacunar
Other
Transient ischemic attack
Treatment regimen, n (%)
Antiplatelets
Anticoagulants
Antihypertensives
Hypolipidemics
Antidiabetics
Abbreviation: SD, standard deviation.

Intervention group, N 5 156

Usual care group, N 5 165

P value

50 (32.1)
106 (67.9)
128 (82.1)
134 (85.9)
67.1 6 7.6

46 (27.9)
115 (69.7)
131 (79.4)
137 (83.0)
67.5 6 9.3

.465
.810
.574
.539
.684

30 (19.2)
0 (0-3)
109 6 87
131 (84.0)
51 (32.7)
124 (79.5)
26 (16.7)
50 (32.1)
12 (7.7)
24 (15.7)

24 (14.5)
0 (0-3)
117 6 84
129 (78.2)
51 (30.9)
125 (75.8)
21 (12.7)
48 (29.1)
18 (5.6)
36 (22.0)

.297
.952
.406
.202
.811
.503
.346
.628
.146
.196

49 (31.4)
23 (14.7)
55 (35.3)
18 (11.5)
11 (7.1)

48 (29.1)
19 (11.5)
67 (40.6)
21 (12.7)
10 (6.1).809

118 (75.6)
31 (19.9)
108 (69.2)
84 (53.8)
34 (21.8)

118 (71.5)
34 (20.6)103 (62.4)
79 (47.9)
33 (20.0)

.402
.870
.199
.285
.875

BASELINE FEATURE OF DMP STROKE TRIAL(30.5%) had chronic kidney disease. The disease subtypes
were as follows: atherothrombotic (n 5 97, 30.2%), cardioembolic (n 5 42, 13.1%), lacunar (n 5 122, 38.0%), otherischemic stroke (n 5 39, 12.1%), and TIA (n 5 21, 6.5%).
No statistically significant differences in the indicators
were observed. There were no differences between the 2groups with respect to subject disability as evaluated bymodified Rankin Scale (Table 3).
The medications taken by the subjects were as follows:
antiplatelets (n 5 236, 73.5%), anticoagulants (n 5 65,
20.2%), antihypertensives (n 5 211, 65.7%), hypolipidemics(n 5 163, 50.8%), and antidiabetics (n 5 67, 20.9%). There
were no significant differences in the use of any of thesedrugs between the 2 groups.

Discussion
The aim of this study is to evaluate the efficacy of DMPs
in preventing recurrent stroke. Patient enrollment wasclosed at the end of November 2012, and follow-up
studies are ongoing. This article describes the study rationale and design as well as the subjects’ baseline features.
Depending on their recovery status and whether they arein the acute, recovery, or maintenance (living) phase ofmanagement, ischemic stroke patients often do not stay inthe same medical institution where they undergo theirinitial consultation. For this reason, maintaining continuous
support for patient education and long-term self-management is difficult. Patient education in medical clinics inJapan is primarily performed by physician, which places alarge burden on physicians and may result in inadequate
patient education. Therefore, this intervention scheme
both supports physicians’ practice and improves patient
outcomes.
Because ischemic stroke has multiple divergent risk
factors, we designed a comprehensive (as opposed to asingle intervention) approach to control these factors.
The aim of the program is for patients to gain knowledge
and to learn techniques that they can use. DMPs strategy
also incorporated behavior modification theories19,21 suchas methods to improve self-efficacy and depression. It
may be possible to investigate the intervention processof recurrence prevention based on the behavior
modification theory.
The limitations of the present study include the small
sample size and the fact that the study could not be
blinded. There was no way to blind the study because
the group assignments had to be explained to patients
when describing the study, and the educational intervention involved additional interaction with nurses that theusual care group did not receive. The sample size of thisstudy was calculated based on a 60% risk reduction ofischemic stroke recurrence with DMPs. It was determinedfrom a previous study evaluating a nurse-directed multidisciplinary intervention for congestive heart failure
with a 56% decrease in readmission.20 And, a stroke

7

recurrence rate in the first year was approximately 5% in
the Japanese stroke centers and 12.8% in the Japanesecommunity-based observational study.15,22 Therefore, we
assumed that 60% reduction rate would be possible
providing disease managements programs to thepatients followed-up in the nonstroke center hospitals or
clinics. In the present study, 52.3% of enrolled patientsare under follow-up in the nonstroke center hospitals or
clinics.
The low recruitment rate (57.1%) is another limitationof this study that may have led to selection bias. Somepatients did not consent even when they were informedat recruitment of the presence of risk factors and of thefact that control of these risk factors influenced recurrence. This indicates that the number of patients who understand that recurrence prevention is important inischemic stroke and that prevention is achieved throughcontrolling risk factors are limited.
To reduce the number of patients with recurrent
ischemic stroke, it is essential that patients understandthe importance not only of rehabilitation but also ofcontrolling risk factors. Our consent rate is similar tothat reported in other studies of stroke.23,24 We
convinced that it is of great importance to thoroughly
investigate the efficacy of DMPs for preventing strokerecurrence.

Conclusion
This article describes the rationale, design, and baselinefeatures of a randomized controlled trial aimed at assessing the efficacy of DMPs in the prevention of recurrent
ischemic stroke. Patient enrollment is closed, andfollow-up studies are in progress. The results derived
from this study could establish the potential usefulness
of DMPs for the secondary prevention of ischemic strokein a primary care setting.
Acknowledgment: The authors would like to thank all
study participants, physicians, nurses, and coworkers fortheir assistance in the preparation and execution of thisstudy.

Supplementary Data
Supplementary data related to this article can be foundathttp://dx.doi.org/10.1016/j.jstrokecerebrovasdis.
2014.10.007

References
1. Herttua K, Tab
ak AG, Martikainen P, et al. Adherence toantihypertensive therapy prior to the first presentation of
stroke in hypertensive adults: population-based study.
Eur Heart J 2013;34:2933-2939.
2. Iestra JA, Kromhout D, van der Schouw YT, et al. Effectsize estimates of lifestyle and dietary changes on

8
all-cause mortality in coronary artery disease patients: asystematic review. Circulation 2005;112:924-934.
3. Van Veenendaal H, Grinspun DR, Adriaanse HP. Educational needs of stroke survivors and their family members, as perceived by themselves and by healthprofessionals. Patient Educ Couns 1996;28:265-276.
4. Shinohara Y, Yanagihara T, Abe K, et al. II. Cerebral
infarction/transient ischemic attack (TIA). J Stroke Cerebrovasc Dis 2011;20:S31-73.
5. Howe RS. The disease manager’s handbook. Massachusetts: Jones and Bartlett publishers Inc 2005.
6. Pimouguet C, Le Goff M, Thiebaut R, et al. Effectivenessof disease-management programs for improving diabetescare: a meta-analysis. CMAJ 2011;183:E115-E127.
7. Stewart S, Carrington MJ, Marwick TH, et al. Impact ofhome versus clinic-based management of chronic heart
failure. J Am Coll Cardiol 2012;60:1239-1248.
8. Ogihara T, Kikuchi K, Matsuoka H, et al. The JapaneseSociety of Hypertension Guidelines for the Managementof Hypertension (JSH 2009). Hypertens Res 2009;32:3-107.
9. Teramoto T, Sasaki J, Ishibashi S, et al. Diagnostic criteria
for dyslipidemia. Executive summary of the Japan Atherosclerosis Society (JAS) guidelines for the diagnosis andprevention of atherosclerotic cardiovascular disease inJapan-2012 version. J Atheroscler Thromb 2012;20:655-660.
10. Japan Diabetes Society. Treatment guide for diabetes
2012-2013. Tokyo: Bunkodo 2012.
11. Sasaki S. Preface: evidence-based practice guideline forthe treatment of chronic kidney disease. Clin Exp Nephrol 2009;13:533.
12. JCS Joint Working Group. Guidelines for pharmacotherapy of atrial fibrillation (JCS 2008). Circ J 2010;
74:2479-2500.
13. National Institute of Neurological Disorders. Special
report from the National Institute of Neurological Disorders and Stroke. Classification of cerebrovascular diseases III. Stroke 1990;21:637-676.

Y. FUKUOKA ET AL.
14. Imai Y, Hasegawa K. The Revised Hasegawa’s Dementia
Scale (HDS-R)-evaluation of its usefulness as a screening
test for dementia. Hong Kong J of Psychiatry 1994;4:20-24.
15. Hata J, Tanizaki Y, Kiyohara Y, et al. Ten year recurrence
after first ever stroke in a Japanese community: theHisayama study. J Neurol Neurosurg Psychiatry 2005;
76:368-372.
16. Kazawa K, Moriyama M. Effects of a self-management
skills-acquisition program on pre-dialysis patients withdiabetic nephropathy. Nephrology Nursing Journal
2013;40:141-148.
17. Radloff LS. The CES-D scale: a self-report depression
scale for research in the general population. Appl Psychol
Meas 1977;1:385-401.
18. Fukuhara S, Bito S, Green J. Translation, adaptation, andvalidation of the SF-36 Health Survey for use in Japan.
Journal of Clinical Epidemiology 1998;51:1037-1044.
19. Prochaska JO, Velicer W. The transtheoretical model ofhealth behavior change. Am J Heal Promot 1997;12:38-48.
20. Rich MW, Beckham V, Wittenberg C, et al. A multidisciplinary intervention to prevent the readmission of elderly
patients with congestive heart failure. N Engl J Med 1995;
333:1190-1195.
21. Bandura A. Self-efficacy: toward a unifying theory of
behavioral change. Psychol Rev 1977;84:191-215.
22. Shinohara Y, Katayama Y, Uchiyama S, et al. Cilostazolfor prevention of secondary stroke (CSPS 2): an aspirincontrolled, double-blind, randomised non-inferiority
trial. Lancet Neurol 2010;9:959-968.
23. Cadilhac DA, Hoffmann S, Kilkenny M, et al. A phase II
multicentered, single-blind, randomized, controlled trialof the stroke self-management program. Stroke 2011;
42:1673-1679.
24. Wolfe CDA, Redfern J, Rudd AG, et al. Cluster randomized controlled trial of a patient and general practitioner
intervention to improve the management of multiple risk
factors after stroke: stop stroke. Stroke 2010;41:2470-2476.