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Effects of a web-based stroke education program on recurrence prevention behaviors among

stroke patients: a pilot study

Jae-Il Kim

¹

, Sook Lee

²

and Jung-Hee Kim

²

*

1Department of Neurology and²Department of Nursing, College of Medicine, Dankook University, Anseo-dong, Cheonan, Chungnam, 330714, Republic of Korea.

*Correspondence to: J.-H. Kim. E-mail: [email protected] Received on August 4, 2012; accepted on February 14, 2013

Abstract

The effectiveness of methods to prevent stroke recurrence and of education focusing on learners’ needs has not been fully explored. The aims of this study were to assess the effects of such interventions among stroke patients and their primary caregivers and to evaluate the feasibility of a web-based stroke education program. The participants were 36 patients with a clinical diagnosis of ischemic stroke within 12 months post-stroke and their primary caregivers. The participants were randomly assigned to either an experimental or a control group. The primary measures included blood chemistry, self-reported health behaviors, sense of control, and health motivation for stroke patients, and caregiver mastery for caregivers. To test the feasibility of the intervention program, the rates of participation and occurrence of technical problems were calculated. The experimental group tended to improve significantly more than the control group in terms of exercise, diet, sense of control and health motivation for the stroke patients and in terms of caregiver mastery for the primary caregivers. The rate of participation in the web-based program was 63.1%. This program, which focuses on recurrence prevention in stroke patients and caregivers, has the potential to improve health behaviors for stroke patients.

Introduction

Stroke is the second-leading cause of death and the leading cause of disability in South Korea. Owing to the development of medical technology and the growing elderly population, the number of post- stroke patients has also been increasing [1].

After recovery from stroke, the recurrence rate is high: one in four strokes is a recurrence, which involves a greater risk of death than the first stroke [2]. Given that recurrent stroke is also preventable, strategies such as acquisition of knowledge of risk factors and lifestyle modification are crucial for successful prevention [3]. Effective management of risk factors is essential for individuals who have suffered a stroke: their 30-day risk for a recurrent stroke is 5–12% without timely treatment and reduction of modifiable risk factors [4].

Adherence to treatment plans to prevent stroke recurrence is relatively low (41–52%); further, 67–85% of stroke patients discontinue medical treatment within 3 months after discharge [5, 6]. The rate of adherence to blood pressure medications and other treatments is<50% among stroke patients [7]. Adherence issues may include a lack of understanding of the side effects and action of medications, as well as individual beliefs about their efficacy [8].

The transformation to a healthy lifestyle requires not only motivation on the part of patients and health professionals but also information, patience and Advance Access published 19 March 2013

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realistic goal-setting [9]. Previously published comprehensive, evidence-based recommendations for the prevention of secondary stroke provide guidelines regarding lifestyle measures, such as modification of hypertension, smoking, hyperlipidemia, diabetes, obesity, excess alcohol consumption and sedentary lifestyles [2]. However, behavioral modifications are not advised at sufficient rates by health professionals [10, 11]; further, the effectiveness of methods of stroke recurrence prevention and of education focusing on learners’ needs has not been fully explored.

Several qualitative studies have indicated that stroke patients and their caregivers perceive barriers to assessing stroke-related information because of its limited availability and suitability to their situations [12, 13]. Further, in assessing stroke information, patients and caregivers prefer a combination of active and passive delivery styles [14]. Haynes et al. [7] also recommended a combination of interventions, including counseling, provision of memory cues, home self-monitoring and supportive follow-up care, to improve medication adherence.

These results showed a way in which health professionals could coordinate and present stroke information to patients and caregivers.

Studies on secondary prevention of cardiovascular disease have shown that family-centered programs have facilitated changes in patients’

lifestyles [15–17]. Interventions that include actively involved patients’ partners and other family members are effective as a result of reinforcement of lifestyle changes [15, 16]. Several other studies have also included and evaluated the effectiveness of caregivers in the context of programs [18, 19].

However, whether caregivers modulate the effects of secondary prevention programs has not been fully determined. Even when interventions have included caregivers, the researchers did not evaluate outcomes with respect to the effects of the caregivers on any improvements [11].

Caregivers of patients with stroke need to manage the care of their family member and support the en- hancement of mastery to continue the caregiver role [20]. Considering that caregiving mastery is defined as the improved provision of knowledge about a

patient’s disease [21], health professionals should pay special attention to their patients’ primary caregivers in providing treatment for the secondary prevention of stroke.

Because of time constraints and considerable variety of information resources in an environment characterized by rapidly changing medical information and health needs, health professionals must test alternative approaches to care delivery that facilitate behavioral changes [22]. Further, only limited information about the use of web-based health technologies among stroke patients is available.

Web-based education programs have been adopted in recent years in an effort to manage health problems in patients with mental disorders [23, 24] and diabetes mellitus [25–27] and to improve mood in stroke survivors and caregivers [18].

Web-based interventions can potentially reach more varied and broad populations than face-to-face interventions can, as the former are available any- time to those with Internet access [27]. Most research related to lifestyle modification and management of chronic diseases has not focused on recurrence prevention in stroke patients, but rather on stroke prevention in the general population or other high-risk groups, such as patients with hypertension or diabetes mellitus.

Because of patients’ dependence on their partners and the decreased sense of control after a stroke [28], the receipt of positive feedback enhances patients’ self-efficacy with regard to certain behaviors [29]. For these patients, providers should develop customized education programs that take into consideration the reinforcement of stroke patients’

self-efficacy for secondary prevention.

Methods

Study design

This study’s web-based stroke education program is a pilot, randomized controlled trial intended to test the program’s effectiveness on stroke patients and their primary caregivers within 1 year after ischemic stroke.

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Study participants

The study was performed in a neurology clinic in Cheonan, South Korea. Individuals who visited a clinic for stroke treatment and had received a clinical diagnosis of ischemic stroke within 12 months post- stroke were invited to participate in the study. The eligibility criteria were as follows: (i) normal cognitive function (a score over 19 on the Korean version of the Mini-Mental State Examination, MMSE-K), (ii) living at home and (iii) Internet access and access to a usable computer. The patients’ primary caregivers were also included as participants.

This study was reviewed and approved by the eth- ical review board of Dankook University Hospital in Korea. The participants were assured of the anonym- ity and confidentiality of all data collected. Informed consent was obtained from all the participants.

In this study of community-dwelling stroke patients and their caregivers, a sample size of 48 was determined to have 80% power to detect a difference of changes between the groups, using a two-group, two-tailed t-test at the 5% significance level. However, low rates of Internet access among potential participants resulted in only 36 participants being recruited to the study.

Procedure

The research coordinator evaluated the stroke patients to determine cognitive impairment and study eligibility. After screening and baseline testing, the participants were randomly assigned to an experimental or control group in a 1:1 ratio, using a computer-generated random code. Baseline evalu- ations were performed during appointments at the stroke clinic. The researcher introduced the web- based program to the intervention group after allo- cation. A guidebook for the program was also provided to both stroke patients and primary caregivers in the intervention group. The guidebook included information about the website and methods to register for and attend a lecture.

Stroke patients

The intervention lasted 9 weeks and was introduced at randomly assigned time points. Follow-up

measurements were scheduled immediately after the 3 months had elapsed. As a research assistant provided Internet technical support by telephone to the intervention group, blinding of the participants and researchers was not possible. However, the face-to-face interviews with stroke patients and the telephone interviews with primary caregivers at baseline and the 3-month follow-up were conducted by a research assistant (not the researcher who delivered the intervention).

Baseline measures included medical history;

general characteristics; the MMSE-K; the Korean version of the Modified Barthel Index (K-MBI);

the NIH Stroke Scale (NIHSS); blood chemistry, including triglyceride and total cholesterol levels;

self-reported health behaviors and psychological measures.

Primary caregivers

The caregivers who accompanied the patients were asked whether they were the primary caregivers of the patients. After giving consent, the caregivers underwent a 15-min telephone or face-to-face interview with a research assistant. In case of time constraints or accompaniment by non-primary caregivers, we conducted telephone interviews. Baseline measures were general characteristics, duration of caregiving and mastery of caregiving.

Primary outcome measures

The primary outcome measures were blood chemistry; self-reported health behaviors such as exercise, cessation of smoking and drinking alcohol, salt and fruit and vegetable consumption; medication adherence and psychological characteristics, including sense of control and health motivation, assessed through the face-to-face interviews.

Caregiver mastery among caregivers was assessed at the 3-month follow-up after baseline assessment.

Blood chemistry

As a biomarker, the participants’ lipid profiles (including the estimation of triglyceride and total cholesterol levels) were performed at baseline and after 3 months. Blood samples were collected into

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heparinized Vacutainers (BD Diagnostics, Franklin Lakes, NJ, USA) at about 9.00 a.m. or 1.00 p.m.

after 8 h of fasting. Assays were performed with Roche Modular DP (Swiss) using proprietary kits.

Health behaviors

Regular exercise, smoking and alcohol consumption were assessed by yes-or-no questions to the participants. Salty food consumption was determined by responses (none, occasionally or very often) to the following question: ‘How often do you consume salty foods?’ The amount of fruits and vegetables consumed per week was also assessed by a self-reported question. To assess medication adherence, the participants were asked to respond to another question (adhere fully, missed occasionally or changed medication dose).

Sense of control

The Mastery Scale [30] was used to measure sense of control. This scale has proven validity and reliability among the elderly [31] and people in Korea who have suffered a stroke [32]. The scale consists of seven items, with each item rated on a four-point scale ranging from 1 (not at all) to 4 (extremely).

Sample items include ‘I have little control over the things that happen to me’ and ‘I can do just about anything I really set my mind to do.’ Five items were reverse-coded, and total scores ranged from 7 to 28 points. Higher scores indicate stronger feelings of control.

Health motivation

Health motivation was also measured in this study.

The Health Motivation Scale consists of seven items scored on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree); total possible scores are 7–35 [33]. Higher scores indicate higher levels of health motivation. The Cronbach’s -value of this scale has been reported to be 0.74 [34].

Caregiver mastery

Caregiver mastery was defined as ‘a positive view of one’s ability and ongoing behavior during the

caregiving process’ by Lawton et al. [35]; it has also been defined more generally as a relatively stable self-image that defines the expectations of the caregiver [36]. Mastery of caregiving was measured using the six-item Care Giving Mastery Scale [35]. High scores indicate greater mastery of caregiving, and possible scores on this scale range from 6 to 24. The scale is reported to have good reliability among stroke caregivers [37].

Secondary outcome measures

The secondary outcome measures of the study relate to feasibility. The feasibility of the program was defined by the rate of participation in the study, the proportion of sessions completed by participants, and the occurrence of technical problems during the study period. The participation rate was calculated by dividing the number of participants by the number of eligible patients who were contacted to participate and converting that figure to a percentage.

The participants completed weekly sessions over the 9-week span. During the 9-week study, the participants were queried about technical problems during their use of the web-based stroke recurrence prevention program once per week.

Additionally, while the research assistant was checking the progress of each session, both the patients and caregivers were asked whether the lecture was understandable and whether the quizzes helpful or useful. The participants were also queried regarding the number of times per week they watched the videos.

Intervention

The program was developed to provide easy access to web-based education that incorporates education and sources to support self-efficacy in home settings for stroke patients and their primary caregivers.

The development processes included phases of analysis, design, development and evaluation. The process of analysis included development of essential study content, learner analysis and analysis of the needs of community-dwelling stroke patients.

Learner analysis was implemented according to

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the results of group interviews among 10 stroke patients. In the design phase, teaching activities, teaching materials and learning activities were es- tablished by session, and in the development phase, video lectures and lecture materials were produced according to the stroke patients’ needs by a neurolo- gist, a rehabilitation physician and two professors of nursing. The rehabilitation physician and one nursing professor participated as the experts of the context in producing the lectures of exercise and nutrition. Three rehabilitation physicians, one professor of physical therapy and one professor of nursing provided testing and evaluation for validity at all phases of the study [38].

During the intervention, a research assistant provided telephone technical support for using the Internet and the program by confirming the progress of each session with the intervention group, including both patients and primary caregivers; this was done because the web-based program did not have a function to track how often the participants re-watched videos.

The web-based program had four major func- tions: (i) repeatable playing of video lectures con- taining tips from health professionals about

recurrence prevention and automated quizzes about them; (ii) automatic feedback with regard to the lectures according to the patients’ own ratings of their health behaviors; (iii) the ability to join an e-mail service to network with health professionals and (iv) reliable external links to websites contain- ing stroke-related information.

Study contents for the nine sessions were selected according to three topical areas: understanding of stroke, recurrence prevention and family life.

Recurrence prevention included control of exercise, adherence to pharmacotherapy and surgery, nutrition, smoking and drinking, blood pressure and diabetes. For the education component, the rehabilitation physician, physical therapist and professor of nursing participated in producing video lectures lasting 15–20 min, using an authoring tool to post Microsoft PowerPoint files. The sessions were designed to be completed on a weekly basis, and they were introduced to participants once per week for a total of 9 weeks. Quiz items were administered after each session on the web; automated feedback was provided to users in response to their inputs. The participants were also able to access external links that contained reliable information on stroke (Fig. 1).

Fig. 1. Conceptual model of the study.

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Before the first session, the web program was designed for participants to enter their overall health behaviors, and then they received automatic feedback with regard to the importance of complet- ing several of the sessions, according to their responses. However, all of the lectures (including those on smoking, drinking, blood pressure and diabetes control) needed to be completed, because risk factors for stroke recurrence include hypertension, diabetes and health risk behaviors, which actually and potentially existed among stroke patients [3].

Each session also had a checklist of recurrence prevention behaviors on which the lecture had been given the previous week; feedback was also provided with regard to the health-care behaviors of the individual stroke patients. The nine sessions were scheduled in a flexible manner, as long as they were completed within the 9-week period.

The program focused on improving stroke- prevention knowledge and self-efficacy of health behaviors, such as medication adherence, appropriate nutrition and reduction of smoking and alcohol consumption. The website also included an e-mail system for contact between participants and health professionals.

During the intervention, a research assistant provided telephone technical support for using the Internet and the program with confirming the progress of each session to the intervention group, including both patients and primary caregivers as this web-based program did not have the function to track how often participants re-watched videos.

The control group received standard care as prescribed by their physicians and no further recurrence prevention advice; they were contacted for endpoint data collection 3 months after the initial interview.

Data analysis

Data analysis was performed using an intention- to-treat analysis to determine the effects of intervention. Endpoint analysis was used for missing value imputation. Descriptive statistics was used to sum- marize baseline characteristics. Group comparisons at baseline and post-intervention were analyzed

using Mann–Whitney U-tests. Chi-square tests were also used to determine whether the number of participants experiencing positive change in terms of various health behaviors after 3 months differed between the groups. P-values were calculated using comparisons between differences in change scores or numbers between the two groups. Statistical tests (where applicable, all tests are two-tailed; the threshold for statistical significance was set as P<0.05) were carried out using SPSS (version 17.0; SPSS Inc., Chicago, IL, USA).

Results

From July to September 2011, 278 potential participants were screened for participation in the present pilot study. A total of 242 of these stroke patients were excluded: 27 had MMSE-K19, 194 had no Internet access and 21 patients eligible for the study declined to participate. Thirty-six patients met the inclusion criteria, provided informed consent for enrollment, and were allocated to the intervention and control groups.

Although 36 patients were randomized to each group, two participants were lost to follow-up as a result of poor health (n¼1) and refusal to complete the follow-up assessment (n¼1). In the intervention group, two primary caregivers were lost to follow- up because they were too busy; in the control group, four primary caregivers declined to complete the follow-up evaluation for the same reason (n¼1), because of lack of interest (n¼1) and illness (n¼2). Sixteen primary caregivers in the intervention group and 14 primary caregivers in the control group completed the program (Fig. 2).

Participant characteristics

Table I shows the patient characteristics of both groups at baseline. The mean (SD) age of the stroke patients was 66.0 (7.4) years (control group:

63.9 [7.4], intervention group: 67.4 [7.3]). The study sample included 23 men among 36 total participants: control group (n¼10) and intervention group (n¼13). The time after stroke ranged from

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1 month to 1 year, with an average of 3.7 (3.3) months. Thirteen participants in the control group and 10 patients in the intervention group had hypertension. Four individuals with diabetes mellitus were in each group. The participants’ mean (SD) scores on the MMSE-K, K-MBI and NIHSS were 27.0 (2.3), 89.6 (10.9) and 0.6 (1.0), respectively. No statistically significant differences between the groups were found with respect to patients’ general characteristics (Table I).

The mean (SD) age of the primary caregivers was 53.0 (13.7) years (control group: 57.3 [11.5]; intervention group: 49.8 [14.8]). The mean period elapsed since they had begun caregiving was 4.5 (5.8) months (Table II). Most of the caregivers

were the patients’ spouses, and all of them were living with the patients.

Primary outcome

To measure differences in the change in biomarkers between the two groups as of the 3-month follow-up, changes in lipid profile (such as changes in triglyceride or total cholesterol) were assessed; however, no between-group differences were found in terms of these indicators (Table III).

Nine (50%) of the participants in the intervention group reported positive changes in exercise, shifting from irregular to regular (P¼0.005). No statistically significant differences in change between the two groups were found with respect to smoking or

Caregivers

Fig. 2. Participants flow diagram.

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alcohol consumption. In terms of diet, 44.4% of the participants in the intervention group reduced their consumption of salty food over the course of the study, while only 27.8% of the control group did so (P¼0.038). The rate of fruit and vegetable consumption increased from 64.1 to 74.7% in the intervention group, and there was a significant difference in this rate of change between the two groups (P¼0.018). Self-reported medication adherence improved in the intervention group, with five participants reporting positive change as of the 3-month follow-up, although this improvement was not statistically significant in terms of the between-group difference in change (P¼0.089) (Table IV).

Significantly greater improvements were observed in terms of sense of control (P¼0.003) and health motivation (P<0.001) for the stroke

patients and in terms of caregiver mastery (P<0.001) for the primary caregivers among the experimental group in comparison with the control group (Table V).

Secondary outcome

Sixty-nine percent (194/278) of the potential stroke participants had no Internet access. The rate of participation in the web-based program was 63.1%

(36/57) among patients with normal cognitive function and Internet access.

During the research assistant’s telephone intervention with the participants, technical support for the program was provided and progress in com- pleting each session confirmed. No participant experienced technical problems during the study sessions.

Table I. Stroke patients characteristics by group Control group (n¼18), mean (SD)

Intervention group

(n¼18), mean (SD) Uor²

Significance (two-tailed)

Age (years) 63.9 (7.4) 67.4 (7.3) 1.1 0.24

Sex (male),n(%) 10 (55.6) 13 (72.5) 1.0 0.47

Times after stroke 3.6 (2.9) 3.5 (3.8) 0.6 0.54

MMSE-K 26.6 (2.4) 27.2 (2.3) 0.6 0.51

NIHSS 0.5 (0.7) 1.1 (1.7) 0.9 0.35

K-MBI 91.7 (9.9) 85.2 (16.1) 0.9 0.35

Hypertension,n(%) 13 (72.2) 10 (55.6) 1.0 0.49

Diabetic mellitus,n(%) 4 (22.2) 4 (22.2) 0.0 1.00

Graduated the middle school,n(%) 10 (55.6) 11 (61.1) 0.1 1.00

NIHSS, NIH Stroke Scale; K-MBI, Korean version of Modified Barthel Index; MMSE-K, the Korean version of the Mini-Mental State Examination.

Table II. Primary caregivers characteristics by group Control group (n¼18), mean (SD)

Intervention group

(n¼18), mean (SD) Uor²

Significance (two-tailed)

Age (years) 57.3 (11.5) 49.8 (14.8) 1.7 0.10

Duration of caregiving (years) 5.2 (5.7) 4.3 (5.3) 1.7 0.24

Above the middle school graduate,n(%) 17 (94.4) 14 (77.8) 2.0 0.33

Relationship to patient,n(%)

Spouse 14 (77.8) 12 (66.7) 2.154 0.341

Son/daughter 4 (22.2) 4 (22.2)

Hired help 0 2 (11.1)

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All participants in the intervention group completed all of the sessions. They finished the nine video-based lectures within the allotted 9 weeks.

Both the patients and primary caregivers reported that the lectures and quizzes were easy to understand and helpful. The mean number of times the videos were watched was 1.23 per lecture for stroke patients and 1.09 per lecture for primary caregivers.

In addition, the physician and nursing professor advised the patients and caregivers by responding to messages received through e-mail (20 messages).

Discussion

The purposes of this pilot study were to assess the effects of an intervention for stroke patients

Table III. Baseline and 3 month follow-up: scores of biomarkers for stroke patients by group

Control (n¼18) Intervention (n¼18)

U P-value

Pre, mean (SD) Post, mean (SD) Change Pre, mean (SD) Post, mean (SD) Change

TG 156.2 (83.1) 145.5 (78.8) 10.7 171.7 (82.2) 140.0 (63.2) 31.7 1.076 0.282

Cholesterol 149.3 (27.3) 144.7 (28.0) 4.6 152.7 (30.7) 154.7 (35.5) 2.0 0.459 0.646 TG, triglyceride.

Table IV. Baseline and 3 month follow-up: health behaviors of stroke patients by group Control (n¼18) Intervention (n¼18)

²orU P-value

Pre Post Pre Post

Regular exercise

Yes 6 7 8 17

No 12 11 10 1

Those who changed positively,n(%) 1 (5.6) 9 (50.0) 8.000 0.005

Smoking

Yes 2 1 4 2

No 16 17 14 16

Alcohol consumption

Yes 2 1 4 2

No 16 17 14 16

Salty food consumption

No 1 6 2 10

Occasionally 12 9 10 7

Very often 5 3 6 1

Fruit and vegetable consumption (%) 61.7 64.1 64.1 74.7

(SD 16.6) (SD 13.2) (SD 21.8) (SD 11.2)

Change 2.4 10.6 2.088 0.037

Medication

Adhered fully 14 11 10 15

Missed occasionally 2 3 5 0

Changed medication dose themselves 2 4 3 3

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who had been diagnosed with stroke within the past year and their primary caregivers and to evaluate the feasibility of a web-based stroke education program that incorporated education and sources of self- efficacy. The effects of the program were determined through comparisons between the intervention group and the control group.

The program was developed to promote repetitive learning about stroke recurrence at any place and time convenient for the participants; it was designed especially to impart knowledge about the prevention of secondary stroke and to promote healthy behaviors. The program includes a special step that could enhance self-efficacy: each session had an accom- panying checklist of enforceable health-care behaviors involved therewith, and automatic feedback was provided at the start of each session.

Thus, this study shows the possibility of pro- moting positive lifestyle changes among stroke patients through a web-based stroke education program, even when contact with such patients in ambulatory clinical settings is limited because of time constraints.

As a result of the program, sense of control and health motivation increased more in the intervention group than in the control group. Individual self- efficacy with regard to specific behaviors can be increased through successful experiences and receipt of positive feedback [29]. The results were also consistent with evidence that self-management approaches resulted in significantly improved self- efficacy and perceived control [8, 39]. Sense of control is described as the extent to which people perceive themselves to be in control of events and everyday situations; it reflects their confidence in

their ability to manage their behaviors [40]. This psychological characteristic has received considerable attention in the management of various chronic diseases [41]. Sense of control contributes to higher health functioning [42] and treatment adherence [43]. Adherence to treatment for cardiovascular risk reduction has also been linked to socioeconomic status, psychological variables such as motivation, desire for change, self-efficacy and sources of health information [43]. Patients’ sense of control over their own lives could be built through home-based activities completed by themselves.

The results of this study correspond well with those of earlier studies reporting that an education program about disease and caregiver skill could lead to reduced caregiver burden and increased caregiving mastery [21, 44]. In light of preliminary evidence, this impact on caregiver mastery could contribute to long-term health maintenance in stroke patients. As caregiver mastery could enhance caregiver role and actively involved the lifestyle changes and adherence for patents, it could facilitate care of stroke survivors [37].

The study results indicated significant changes in exercise behavior and salt, fruit and vegetable consumption among participants in the intervention group within 12 months post-stroke. Gillham and Endacott [11] also showed that enhanced secondary prevention influenced exercise and diet behaviors in the early phase following minor stroke and transient ischemic attack. Considering that lifestyle modification is effective at earlier stages [2], this program would be more effective for secondary prevention at the early phase after a stroke has occurred.

Table V. Baseline and 3 month follow-up: scores of psychological variables of participants by group

Range

Control, patients (n¼18), primary caregiver (n¼18)

Intervention, patients (n¼18), primary caregiver (n¼18)

P-value Pre

mean (SD) Post

mean (SD) Change Pre mean (SD)

Post

mean (SD) Change U

Sense of control 7–28 16.5 (4.5) 17.6 (4.1) 1.1 16.0 (4.1) 19.8 (3.7) 3.8 2.970 0.003 Health motivation 7–35 21.6 (3.8) 22.6 (3.8) 1.0 22.6 (5.3) 32.4 (3.1) 9.8 4.242 <0.001 Caregiver mastery 6–24 19.3 (2.9) 19.7 (2.8) 0.5 20.0 (2.8) 22.8 (2.5) 2.8 4.258 <0.001

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However, there were no changes in terms of cigarette smoking or alcohol consumption in the intervention group. Our study targeted stroke patients who had been diagnosed within the past 12 months because that initial period is an important time for medication adherence and lifestyle modification. A cohort study reported that effective interventions to improve persistent secondary prevention after stroke should be developed during the first 2 years post-stroke, as secondary prevention treatment tended to decline rapidly during that time [45].

As the addictive nature of alcohol and cigarettes makes sustained behavior modification difficult [46], psychological variables such as feelings of control and motivation are important for the maintenance of lifestyle changes [42, 46].

In addition, no significant effects on biomarkers, such as lipid profile (i.e. triglyceride or total cholesterol levels) were found. Another intended lipid-lowering intervention comprising modification of diet and exercise did not produce significant changes in lipid profile within 4 months [47]. Yet another lifestyle intervention over 2 years reduced cholesterol in patients with coronary heart disease [48]. Further studies should explore the long-term effects of a web-based program among stroke patients and their caregivers.

Stroke patients with hyperlipidemia had taken lipid-lowering agents to lower their cholesterol.

The program’s lack of impact on lipid profile sug- gests that the time of endpoint data collection and the stage of stroke diagnosis are useful targets for future studies. In the same context, we did report only medication adherence, as the blood pressure of entire patient with hypertension was in the normal range due to the vigorous hypertensive treatment including medication therapy. Therefore, more research remains to be conducted on this program designed for the early post-stroke period in terms of lowering cholesterol.

In this study, medication adherence improved among the intervention group compared with the control group, in which several participants occasionally forgot to take their medication or changed their medication doses on their own over time.

However, overestimation of treatment effects might

have occurred, as all of the primary outcomes except for blood chemistry readings may be subject to self-report bias. Future studies should consider measuring other objective data, such as blood pressure and weight, in the early stage after stroke.

The positive result of this study could be the impact of the secondary outcomes. The small impact on health behaviors might be caused by the study’s lack of power, but the observed results are encouraging for future larger trials: there were non-significant changes that might have achieved significance in a larger study.

The web-based approach was found to be potentially applicable to only 36 of the 278 considered stroke patients as well as caregivers, because all of them were living with the patients. The program would be limited to people with Internet access and computer, as the majority of potential participants lacked Internet access. This also reflects the fact that although Korea is one of the top 20 Internet countries [49], the usability of the Internet among the elderly and disabled is still low. With the expected growth in digital media, this circumstance is likely to improve in the future as the Internet becomes more readily available.

The rate of the participation might be better in primary care, because web-based stroke recurrence programs are applicable to all patient groups who are at high risk of cardiovascular disease and its potential complication of stroke. All such patients need professional support to achieve healthy lifestyles and optimal treatments; therefore, the program could be used in routine clinical practice.

Nijlandet al. [26] also pointed out that use of a web application was negatively affected by low enrollment related to the lack of Internet access and non-usage attrition. In their study, 32% of the diabetic patients discontinued use of the application because it was not user-friendly.

However, the interventions were successfully delivered to 18 participants during the 9 weeks;

only two patients were lost to follow-up. The lack of dropout might be caused partly by the guidebook for the program and the availability of technical support and checking the progress of each session by

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telephone, which could aid in the continuous use of the program; the simplified, web-based program, which required only a relatively easy login procedure to attend the lectures, also probably contributed to program utilization. In addition, by improving knowledge of prevention caregivers could assist the patients to use the web-base intervention program as well as involve the lifestyle changes for patients. Because the caregiver mastery could enhance the caregiver role [37].

To overcome the challenges of online education, a special aspect of the web-based health education program that could enhance self-efficacy seemed to be effective. This approach could improve sense of control and health motivation as well as health behaviors among patients. Additionally, the participation of patients’ primary caregivers might lead to successful delivery of web-based interventions.

Limitations

This study has some limitations. First, because of its small sample size, this pilot study did lack the power to detect all of the differences between groups. A larger randomized controlled clinical trial is needed to confirm the benefits of the intervention.

Second, the study’s duration was 3 months, which may underestimate the potential effects of the program. As a result, we can only definitively conclude that the web-based stroke recurrence program is par- tially effective in the short term among the participants. Thus, the results remain inconclusive with regard to different outcomes and points in time, and the long-term effects of the stroke education program remain unclear. We are also aware that recall bias, social desirability bias and intrinsic self-rating scales may affect the validity of the findings, although this applies equally to the control and intervention groups.

Conclusion

Despite these limitations, the current research rep- resents the first randomized study showing that a web-based education program is a feasible and potentially effective intervention to enhance

lifestyle modification and sense of control and mastery in stroke patients and their caregivers.

Although contact with stroke patients in ambulatory clinical settings is limited because of time constraints, it is still possible to promote positive lifestyle changes through a web-based stroke education program. Such a program has the potential to improve health behaviors among stroke patients, and it could be suitable to the radically changing medical environment and appropriate for patients’

evolving health-care needs.

Funding

This work was supported by Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology [20110003345].

Conflict of interest statement None declared.

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