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Impact of a serious game for health on chronic disease self-management: preliminary efficacy among community dwelling adults with hypertension.

ABSTRACT

Most Americans will acquire a chronic disease during their lifetime. One of the most prevalent chronic diseases that affect Americans is hypertension (HTN). Despite the known comorbidities and increased mortality rate associated with uncontrolled HTN, most community dwelling adults with HTN do not have sufficient blood pressure control. Therefore, the aim of this article is to report the preliminary efficacy of a serious game for health to enhance blood pressure control among community dwelling adults with HTN. A nonprobability sample of 116 community dwelling adults with HTN participated in this nonblinded, randomized controlled trial. Participants were randomly assigned to: (1) an intervention arm that consisted of four exposures to a serious game for health known as eSMART-HD; or (2) an attentional control arm that compromised of four exposures to screen-based HTN education. The primary outcome measure for this trial was blood pressure reduction over a four month observational period. In this study, baseline characteristics and blood pressure measurements were similar between-group difference in blood pressure reduction over time. However, there were significant within-group reductions in systolic and diastolic blood pressures across time among favoring participants exposed to eSMART-HD. This study establishes the preliminary efficacy of eSMART-HD that can be easily administered to community dwelling adults and facilitate clinically significant reductions in systolic and diastolic blood pressures. Future studies should assess the influential components of this promising serious game for health (eSMART-HD) combined with medication management in larger and more diverse samples of community dwelling adults with HTN.

Keywords: serious games for health, self-management, hypertension, community dwelling adults, avatars

INTRODUCTION

In the United States, almost half of the general population will acquire a chronic disease. One of the most prevalent chronic diseases that affect Americans (aged [greater than or equal to]18 years) is sustained elevations in blood pressure. It is estimated that 68 million (31%) Americans live with elevated blood pressure consistent with a clinical diagnosis of hypertension (HTN; systolic blood pressure of more than 140 mmHg and a diastolic blood pressure of more than 90 mmHg) (CDC, 2011). Among one of the most prevalent chronic diseases that affect Americans, HTN is attributed to approximately 1,000 deaths per day and significant reductions in the lifespan of Americans with sustained states of uncontrolled HTN (CDC, 2011).

Despite the recognition of uncontrolled HTN as a significant public health problem, a significant proportion of individuals living with HTN do not have optimal blood pressure control. Among Americans living with HTN, it has been cited that nearly half of these individuals do not have optimal control of their blood pressure (Egan, Zhao, & Axon, 2010; Wong et al., 2007). Even when individuals with HTN seek medical care from healthcare providers, more than two-thirds of these individuals know that their blood pressure is uncontrolled and half will maintain taking their antihypertensive medications a year after treatment initiation--resulting in poor blood pressure control (Hill, Miller, & DeGeest, 2011; Moser & Franklin, 2007; Vrijens, Vincze, Kristanto, Urquhart, & Burnier, 2008). Together, poorly developed treatment plans prescribed by healthcare providers and minimal demonstration of hypertension self-management by individuals with HTN synergistically culminate into disparate health outcomes and ineffective healthcare resource utilization (Cooper et al., 2009). Emphasis on the quality of patient-provider interactions and shared decision making, as well as activation of self-management behaviors are promising research foci posited to improve blood pressure control among individuals with HTN (Krousel-Wood, Muntner, Islam, Morisky, & Webber, 2009; Martin, Roter, Beach, Carson, & Cooper, 2013).

BACKGROUND

Given the substantial contribution of uncontrolled HTN to an individual's estimates of morbidity and mortality, there is an urgent need for innovative and effective strategies that can improve hypertension self-management. A recent scientific statement published by the American Heart Association [AHA] (Pearson et al., 2013) underscores the need for community-based strategies that can be administered through electronic media (i.e., telephone, internet, mobile devices, or serious games for health) and focus on a range of influential factors, such as race/ethnicity, socioeconomic status, health literacy, and geographic location to optimize behavioral changes that reduce the disparate health outcomes associated with uncontrolled HTN. In response to the AHA scientific statement on HTN, there is an acknowledged urgency to develop and test community-based interventions that the encourage individuals with uncontrolled HTN to proactively become informed about their chronic disease, participate in shared decision making for their blood pressure control, and execute self-management behaviors, such as medication adherence, lifestyle modification, and tobacco cessation (Pearson, et al., 2013).

Although there is an emerging evidence base on efficacious self-management interventions, there has been minimal research that have explored the benefits of experiential learning of self-management behaviors through exposure to a serious game for health among community dwelling adults. There is a paucity of interventional research that has centered on the use of serious games for health to improve chronic disease outcomes in children (Baranowski et al., 2011). Among children, serious games for health are developmentally appropriate and effective strategies that educate, build self-efficacy, and facilitate health behavior changes (Baranowski et al., 2011; Kharrazi, Faiola, & Defazio, 2009; Thompson et al., 2010). Despite this promising evidence among children, there has been limited effort to evaluate the efficacy of serious game technologies among adults living with a chronic disease. With a closing digital divide, serious game technology may provide an effective platform to provide community dwelling adults with an experiential learning experience that can lead to "real-life" behavior changes and improved health outcomes. Therefore, the aim of this article is to report the preliminary efficacy of a serious game for health to enhance blood pressure control among community dwelling adults with HTN.

METHODS

Design

The study design was a nonblinded, randomized controlled trial with a five month observational period. Participants were randomly assigned to an attention control (screen-based education on hypertension self-management) or an experimental condition (a serious game for health referred known as electronic Self-Management Resource Training to reduce Health Disparities [eSMART-HD]). All participants were exposed to 4 monthly doses of an experimental condition

Participants

A non-probability sample of community dwelling adults was recruited through advertisements placed in local, community newspapers, businesses, and posters affixed within a fleet of public buses. Potential participants contacted the research staff by telephone for further evaluation of their study eligibility. Recruitment of subjects was conducted between October, 2010 and July, 2011 from communities in Northeast Ohio.

Community dwelling adults with diabetes mellitus, chronic lung disease, and/or hypertension were eligible for enrollment into this study if they were aged 18 years or older. Specifically, individuals with hypertension were eligible if they were receiving treatment for hypertension with two or fewer antihypertensive medications, had a baseline systolic blood pressure (SBP) of more than 140 mmHg and diastolic blood pressure (DBP) of more than 90 mmHg, were willing to monitor their own blood pressure, were willing to discuss the management of their hypertension with a healthcare provider, and were able to understand English. Community dwelling adults who were deaf and blind, unable to understand English, or did not have access to a primary care provider were excluded from participating in this study.

Randomization

Participants who met the inclusion criteria were sequentially assigned to either the attention control or intervention condition on the basis of a computer generated allocation sequence (1:2 ratio), which was concealed from the research staff in opaque sealed envelopes. The study investigators, research staff, and participants were not blinded to group assignment in this randomized controlled trial. Additionally, the outcome measure, blood pressure measurements by automatic sphygmomanometer, were not blinded to the study investigators or research staff to ensure that critical blood pressures were evaluated and participants received immediate referral to their primary care providers.

Procedures

Screening and recruitment. Potential participants who saw our recruitment advertisements and wished to participate in this study were instructed to call our research office for further assessment of their eligibility. After the telephone screening for study eligibility was conducted and the eligibility of a potential participant confirmed, the research staff introduced the study procedures to the potential participants and scheduled baseline appointments at one of five community sites for data collection.

Baseline and monthly follow-up interviews. At the baseline study interview, written informed consent was obtained and participants were allocated to a study condition (attention control or intervention condition). The baseline and four monthly follow-up interviews each took approximately one hour to complete the study questionnaires, blood pressure measurements, and deliver a dose of an intervention condition.

After randomization, all participants were administered a battery of study questionnaires, which consisted of demographic items, and several psychosocial and behavioral surveys. After the administration of the study questionnaires, blood pressure measurements were obtained. The same automatic sphygmomanometer was used on all participants. Three serial blood pressures measures were obtained with a one minute interval of time between each blood pressure measurement. The cuff of the sphygmomanometer was placed on the participant's left upper extremity unless that patient had a preexisting medical condition, such as placement of an intravenous catheter, arteriovenous fistula, or prior breast mastectomy with lymph node dissection, that precluded the participant from having his/her blood pressure measured. In these few instances, the research staff obtained the serial blood pressure measurements on the right upper extremity for this subgroup of participants.

Administration of the experimental conditions. After completing the study questionnaires and providing blood pressure measurements, participants were exposed to one of the two study conditions at each monthly study visit. At each study interview, the research staff set up a computer station prior to the participant's arrival to the study site. A designated member of the research staff was available to participants if they experienced technical difficulties with the attention control or intervention conditions. If the participant encountered a technical difficulty, all attempts were made to restart the participant at the point where they encountered the difficulty. However, there were a few instances where the participant had to restart at the beginning after experiencing a technical difficulty.

Experimental Conditions

Attention control. Participants assigned to the attention control condition were exposed to screen-based education focused on hypertension and self-management strategies, such as symptom recognition, diet, exercise, and stress management. The attention control arm was designed to provide passive screen-based education on hypertension in accordance with evidence-based practice guidelines (NHLBI, 2004). Participants were exposed to the same 20 minute video, which provided the on-screen text, closed caption, and audio. Each participant assigned to the attention control arm was exposed to three monthly doses of this study condition over the four month observational period.

Intervention. Participants allocated to this condition were exposed to a serious game for health referred to as eSMART-HD. This chronic disease self-management intervention, eSMART-HD, was co-created through iterative cycles of focus groups with individuals living with chronic health conditions (i.e., hypertension, diabetes mellitus, chronic lung disease) and the study investigators. eSMART-HD integrates interactions with avatar-based healthcare professionals and use of a structured communication system referred to as SBAR3 to provide participants with cognitive and behavioral strategies that enhance their interactions with their "real life" healthcare providers and improve their chronic disease self-management..

Similar to simulation, the eSMART-HD intervention provides a safe, nonthreatening environment that permits users to practice their self-management and communication skills by interacting with avatar healthcare providers, staff, and a health coach. eSMART-HD provides customized real-time feedback and educational resources based on the participant's performance during a virtual office visit. Even though the eSMART-HD technology was designed to address multiple chronic conditions, the instructional design is customized to the participant's specific chronic condition. Participants who wish to clarify their understanding of the structured communication strategy (SBAR3) or disease-specific educational content had the option of requesting help from their virtual healthcare coach or simply accessing the supplemental educational materials from the help toolbar on the screen.

eSMART-HD is a serious game for health that provides opportunity for participants to interact with three-dimensional (3D) avatars that portray a health coach, receptionists, medical assistants, and healthcare providers in a virtual health clinic. Participants who were exposed to this intervention interacted with the 3D avatar characters by selecting preprogrammed responses on the screen that initiated customized responses from the avatar characters. Participants assigned to the eSMART-HD arm received 4 monthly doses of this 20 minute screen-based intervention. In addition to exposure to eSMART-HD, this cohort of participants were also given a pocket sized trifold with the instructions on how to: record their medications and daily home monitoring measurements of their blood pressure; and use the SBAR3 communication strategy in their "real life" interactions with healthcare providers, which was printed on the trifold as behavioral reinforcement.

Primary Outcome

The primary outcome for this study was reduction of SBP and DBP between and within the experimental conditions over four months. Serial blood pressure measurements were collected systematically using an automatic sphygmomanometer. At baseline and follow up study interviews, a total of three blood pressure measurements were taken with a one minute interval between each blood pressure measurement. The lowest SBP and DBP for each study visit were used to assess the primary outcome, reduction in blood pressure. For this study, a clinically significant reduction was defined as a 5 mmHg in the SBP or DBP across the four month observational period, which is consistent with previous intervention studies aimed at improving hypertension self-management in samples of community dwelling adults with HTN (McManus et al., 2010).

Ethical Approval

Prior to data collection, university institutional review board approval was obtained. Eligible community dwelling adults living with a chronic health condition (i.e., hypertension, diabetes mellitus, and chronic lung disease) were approached by a research staff who reviewed the risks and benefits, explained what was expected from participants, and emphasized the voluntary nature of participating in this clinical trial. If the eligible community dwelling adult wished to participate in this study, written informed consent was attained. At the conclusion of each study interview, participants received an incentive in the form of a $20 retail or restaurant gift card of their choice.

Statistical Analysis

Three sets of statistical analyses were performed all using repeated measures analysis of variance (RMANOVA) to examine mean differences in systolic and diastolic blood pressures over four time waves. First, a 4 X 2 RMANOVA (four time points by two groups) was used to determine if there were significant mean differences over time between the intervention and control groups. Second, another set of RMANOVAs were conducted separately for the intervention and the control groups to identify if significant difference in the means over time for each group. Lastly, three additional secondary sets of 4 X 2 RMANOVAs were run separately comparing between group differences in gender, race (white vs. nonwhite), and body mass index (BMI, <25 kg/[m.sup.2] vs. [greater than or equal to]25 kg/[m.sup.2]). The statistical assumptions for RMANOVAs were met and the level of significance (p) for each statistical test was [less than or equal to] .05.

RESULTS

Descriptive Analysis of Sample Characteristics

The sample consisted of a total 144 participants; however, only 116 community dwelling adults met our HTN criteria. Preliminary analyses of systolic and diastolic blood pressure comparing mean differences over four time waves between the intervention and the attention control groups indicated significant mean differences over time for systolic blood pressure ([F.sub.(3,342)] =2.78; p<.05) and diastolic blood pressure (([F.sub.(3,342)] =3.92; p<.01). However, there were no significant differences between groups (intervention vs. control) and the interaction of time by experimental condition for systolic and diastolic blood pressure. Upon further review of the means and plots showed a consistent decline in both systolic and diastolic blood pressures over time for the intervention group, while no discernible pattern was seen for the attention control group. With these findings, a separate set of RMANOVAs were conducted for the intervention and control groups across the four time points for diastolic and systolic blood pressures. A summary of the clinical characteristics of participants assigned the intervention group are presented in Table 1.

Evaluation of Between- and Within-Group Differences in Blood Pressure Reduction

The primary analyses of testing for mean differences over time for systolic and diastolic blood pressures were not significantly different for the control group. However, for the intervention group, systolic blood pressures significantly decremented over the four time waves ([F.sub. (3, 228)] = 3.10; p<.05) as shown in Figure 1. Diastolic blood pressures (see Figure 2) in the intervention group also significantly declined over the four time waves ([F.sub. (3, 228)] = 3.92; p<.01), which is illustrated in Figure 2. Table 2 provides a summary of the means and standard deviations of the systolic and diastolic blood pressures for the intervention and the control groups.

Influence of Gender, Race, and Body Mass Index on Blood Pressure Reduction

As this study was exploratory, three additional secondary sets of 4 X 2 RMANOVAs were conducted for cases assigned to the intervention condition to identify if group differences existed in gender, race (white vs. non-white), and body mass index (<25 kg/[m.sup.2] vs. >25 kg/[m.sup.2]). For gender, significant systolic mean differences were found over time ([F.sub. (3, 225)] = 3.28; p<.05; observed power=.75). However, there were no significant effects for gender and the gender by time interaction. Significant diastolic mean differences were found over time ([F.sub. (3, 225)] = 4.05; p<.01; observed power=.84) and between males and females ([F.sub. (1, 75)] = 5.56; p<.05; observed power=.61). However, there were no significant effects for the gender by time interaction. For race, no significant systolic effects were found. However, significant diastolic mean differences were found in comparing whites with non-whites ([F.sub. (1, 75)] = 8.59; p<.01; observed power=.84). There were no significant systolic effects across time or for the race by time interaction. For BMI (<25 kg/[m.sup.2] vs. [greater than or equal to]25 kg/[m.sup.2] or greater), differences in systolic blood pressures were found ([F.sub. (1, 75)] = 17.99; p<.001; observed power=.99). For the BMI by time interaction, there was no significant change in systolic blood pressure across time. Significant mean diastolic blood pressure differences were found over time ([F.sub. (3, 225)] = 4.39; p<.01; observed power=.87) and between those individuals stratified by BMI ([F.sub. (1, 75)] = 7.30; p<.01; observed power=.78). However, there was no significant BMI by time interaction. For this set of exploratory secondary analyses, these results should be cautiously interpreted since this study was not adequately powered to examine these relationships. Therefore, these secondary results are only presented as potential explanations for the observed mean differences across time in systolic and diastolic blood pressures found among participants exposed to the intervention condition.

DISCUSSION

Hypertension self-management has been elucidated as an effective strategy to improve blood pressure control. With a closing digital divide, the use of technology to enable better living, strengthen social networks, and improve communication has become increasing more prevalent among community dwelling adults. Serious games for health offer opportunities to educate and facilitate health behavioral changes. However, a vast majority of research on the delivery of serious games for health to enhance self-management behaviors has been undertaken among children and adolescents. Thus, the primary objective of the research was to explore the impact of a serious game for health (eSMART-HD) on chronic disease self-management. Although eSMART-HD was developed and evaluated in community dwelling adults living with diabetes mellitus and chronic lung disease (i.e., asthma and chronic bronchitis), this article reports the preliminary efficacy of the eSMART-HD among community dwelling adults with HTN.

In our evaluation of the efficacy of the eSMART-HD, we found no significant differences in blood pressure reduction over a four month observation period among participants exposed to three doses of eSMART-HD when compared to participants exposed to three doses of attention control. Although the premise of the randomized controlled trial was to establish the efficacy of eSMART-HD for chronic disease self-management, for this reason, this clinical trial does not have sufficient statistical power to detect between group differences for chronic disease subgroups (i.e., diabetes mellitus, chronic lung disease, and HTN). In an effort to further evaluate the efficacy of eSMART-HD, a series of repeated measures of analysis were carried out to examine within group change over time in blood pressure reduction among participants randomly assigned to this experimental condition.

Three monthly exposures to eSMART-HD facilitated statistically and clinically significant reductions in blood pressure. At baseline, there were no mean differences in the systolic or the diastolic blood pressures. Over time, the participants assigned to the attention control condition demonstrated no significant change in their mean systolic or diastolic blood pressures. In contrast, participants who assigned to eSMART-HD had significant improvements in their systolic and blood reductions over time. On average, participants exposed to three doses of eSMART-HD demonstrated reductions in their systolic and diastolic blood pressures of 7mmHg and 5mmHg respectively. Based on our a priori criterion for the primary outcome of blood pressure reduction, participants who received eSMART-HD were likely to have a clinically significant improvement in their blood pressure control.

To further investigate the effects of eSMART-HD on study participants, a set of secondary exploratory analyses were conducted to examine the influence of gender, race, and BMI on blood pressure reduction. In this cohort of community dwelling adults exposed to eSMART-HD, our exploratory secondary analyses revealed that on average participants who were female and had a BMI of less than 25 kg/[m.sup.2] were more likely to have significant reductions in their systolic and diastolic blood pressures. It is plausible that the differences found by stratifying the cohort by gender and BMI revealed two subgroups that were inherently more likely to engage and sustain HTN self-management behaviors. However, we caution the interpretation of these secondary exploratory findings and offer these results potential explanatory variables for the therapeutic response demonstrated among participants exposed to eSMART-HD.

Limitations

There are several limitations that influence the internal and external validity of this study. First, this study did not implement a strategy to minimize the variability in medication management among study participants. Although we recognize the lack of a medication management protocol as a limitation, this study is naturalistic in the sense that it reflects the naturally occurring variability in medication management that differs by prescribing healthcare practitioner and care recipient. Larger sample sizes are required to adequately assess the efficacy of the eSMART-HD. Second, the relatively small sample size for this study does not provide sufficient statistical power to detect between-group (experimental vs. attention control) differences in blood pressure reduction across time. Lastly, we are unable to discern the components of the eSMART-HD that were efficacious or most beneficial to participants; however, future research should focus on identifying subgroups of participants who were responders and examine the beneficial components of eSMART-HD.

CONCLUSION

A serious game for health, eSMART-HD, is a promising strategy for HTN self-management to improve blood pressure control among community dwelling adults. This randomized controlled trial is one of the first to leverage the advances in serious game technology to create and evaluate the efficacy of a serious game for health to educate, train, and improve blood pressure control among community dwelling adults. Our preliminary findings confirm the efficacy of eSMART-HD. Specifically, participants who were exposed to three monthly doses of eSMART-HD had clinically significant reductions in their systolic (7 mmHg) and diastolic (5mmHg) blood pressures. Recent research (Pinto, Hickman Jr, Clochesy, & Buchner) that adapted the eSMART-HD to improve depression self-management further extends the preliminary efficacy of eSMART-HD demonstrated in this sample. Future research is recommended that combines eSMART-HD and medication management in larger randomized controlled trial with community adults with HTN to further evaluate the effectiveness of eSMART-HD on blood pressure control.

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RONALD L. HICKMAN, JR.

Case Western Reserve University

JOHN M. CLOCHESY

University of South Florida

MELISSA D. PINTO

Emory University

CHRISTOPHER BURANT

GRANT PIGNATIELLO

Case Western Reserve University

Table 1.
Sample characteristics of participants (n=144)

                     Intervention (n=97)     Control (n=47)
Variable              Mean            SD       Mean          SD
Age, years             49.3          12.7       46.6         13.5
Baseline SBP, mmHg    140.2          24.4      136.2         23.8
Baseline DBP, nmiHg    86.4          15.1       84.3         15.6

                       No.           %          No.           %

Gender: Male           40            42.6       16           34
Race: White            25            26.6        9           19.1
Education
Hiah School or less    34            36.2       22           46.8
2-4 yrs. College       49            52.1       21           44.7
Graduate Desree        11            11.7        4            8.5

Note. BMI=body mass index, SBP=systolic blood pressure, DBP=diastolic
blood pressure.

Table 2.
Means and standard deviations for systolic and diastolic blood
pressures over four months by group assignment (N=116)

                 Baseline      T1           T2           T3
Group            M(SD)         M(SD)        M(SD)        Af (SD)
Assianment

                       Systolic Blood Pressure

Intervention     139.87        138.03       137.96       132.84
(n=77)           (23.63)       (22.56)      (20.90)      (17.50)

Control (n=39)   136.00        137.05       131.69       132.90
                 (22.55)       (19.99)      (17.54)      (23.74)

                      Diastolic Blood Pressure

Intervention      86.65         84.62        83.39        81.88
(n=77)           (15.78)       (12.82)      (13.82)      (14.01)

Control (n=39)    84.26         83.64        80.18        82.49
                 (15.87)       (10.49)      (12.24)      (13.65)
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Author:Hickman, Ronald L., Jr.; Clochesy, John M.; Pinto, Melissa D.; Burant, Christopher; Pignatiello, Gra
Publication:Journal of Health and Human Services Administration
Article Type:Report
Date:Sep 22, 2015
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