Abstract
Introduction
Wearable device (WD) interventions are rapidly growing in chronic disease management; nevertheless, the effectiveness of these technologies to monitor telehealth outcomes has not been adequately discussed. This study aims to evaluate the effects of WDs in adherence and other health outcomes for people with chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), and cardiac disease (CD).
Methods
CINAHL, PsycINFO, CENTRAL, and EMBASE were searched for randomized controlled trials (RCTs) and non-RCTs from 1937 to February 2020. Studies comparing interventions with the use of WD were assessed for quality in RCTs and a meta-analysis was performed.
Results
Eleven studies were included in this review. All of the interventions involved WD use with educational support such as goal setting, virtual social support, e-health program, real-time feedback, written information, maintain diary, and text messaging. The meta-analysis showed no difference in adherence (p = .38). The DM group showed effects of more than a 2% reduction in weight when WDs were implemented for three months (risk ratio = 2.20; 95% confidence interval (CI) 1.38 to 3.50; p = .0009), as well as blood glucose (mean difference (MD) = –32.39; 95% CI = –48.07 to –16.72; p < .0001), haemoglobin A1c (MD = –0.69; 95% CI = –1.28 to –0.10; p = .02), and physical exercise time in the CD group (MD = 9.53; 95% CI = 0.59 to 18.47; p = .04).
Discussion
WD with educational support may be particularly useful for people with DM and CD to enhance support beyond usual care. The results of this review showed insufficient evidence to support the use of WD for COPD to enhance telehealth outcomes for disease management.
Keywords
Introduction
The wearable medical device market is rapidly growing, with 27.9% annual growth predicted from 2020 to 2027, and home healthcare and remote monitoring is expected to influence demand for these devices.1 A wearable device (WD) is defined as a sensory device that can be attached to clothing or worn as an accessory, allowing tracking of health information without hindrance.2–5 WDs were essentially developed for fitness and health promotion use and to promote wellness, and they have the ability to accurately track health-related activities.6 These devices have the potential to capture information with real-time synchronization and monitoring, allowing healthcare providers to monitor and assess health conditions, communicate effectively, manage risk factors, and gain feedback – all of which help enable self-management.7,8
Recent studies have reported that a WD could be used for continuous monitoring and early diagnosis for patients who have chronic diseases, including cardiac disease (CD),9–11 diabetes mellitus (DM),11 chronic obstructive pulmonary disease (COPD),11 Parkinson’s disease,12 cancer,13 and mental disorders.9 WDs could also be useful in the areas of gerontology14 and mobility support.15 To help monitor chronic conditions, they can also track the status of multiple health-related parameters such as step counting, energy expenditure, activity-time duration, sleep status, body temperature, oxygen saturation, and electrocardiogram.9–16
A non-invasive WD offers an efficient and cost-effective solution that allows patients to monitor health-related parameters without expensive costs.17 Although previous studies have explored how this solution could benefit home-monitoring-based telehealth/telenursing, the effectiveness of using these technologies as well as users’ adherence and type of education for continuous disease management and telehealth outcomes have not been adequately discussed.
Telemonitoring health status with technology in chronic disease management
Chronic diseases are conditions characterized by a long duration and slow progression.18 They are currently increasing and represent 71% of all causes of death worldwide, killing 41 million people each year.19 Concerning older adults, age-related frailty and illness are commonly affected by environmental and lifestyle factors.20 Therefore, the ability to monitor people’s daily status non-intrusively to find physical changes has merit.
Telemonitoring is an important aspect of telehealth that includes remotely collecting and sending people’s data for interpretation, and it can be used in ongoing healthcare.21 It involves self-monitoring and/or healthcare providers monitoring from a distance to improve health behaviour.22 Daily telemonitoring using non-WDs for people with chronic diseases such as COPD, DM, and CD has a positive effect on health outcomes23–25 and in detecting early-stage changes.26
In recent years, several types of wearable technologies have been introduced to support people with chronic conditions in home care settings, and several reports suggest that they have the potential to assist in predicting clinical outcomes.12,13,27–31 One study32 reported that data can be transmitted to healthcare providers to interpret and provide feedback in the management of chronic diseases. It was suggested that WDs are acceptable and feasible for people with chronic conditions. However, various studies have reported only the effectiveness of using WDs without intervention from healthcare providers. Further, the current evidence relating to the effectiveness of using WDs for chronic disease management, patient outcomes, and adherence is unclear. Moreover, while educational support plays an important role in chronic disease management,33 the use of WDs and educational support for chronic disease management in telehome-care have not been discussed. Therefore, the current study focused on exploring WD-use interventions to monitor chronic conditions and evidence. This systematic review and meta-analysis evaluated the adherence to and effectiveness of the use of WDs and educational interventions to improve telehealth outcomes for people with chronic diseases like COPD, DM, and CD.
Methods
In this systematic review, we followed the steps in the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement.34 The protocol was registered in the International Prospective Register for Systematic Reviews (PROSPERO) CRD 42018111632.
Published work search strategies and sources
We performed a comprehensive literature search of published work. Search dates for databases were not limited. The databases used in this study were the Cumulative Index of Nursing and Allied Health Literature Plus with Full Text database (including PsycInfo and MEDLINE) through the EBSCOHOST interface, PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials. All databases, key words, and combinations used in the search are shown in Table 1. The search for published work was performed twice (in October 2018 and February 2020) to facilitate the inclusion of updated published work. Published conference proceedings that included abstracts were also reviewed. Gray literature such as unpublished articles or those that were not easily accessible via databases were not included. A manual search was performed to identify article references of research papers published in engineering journals.
Searched database and keyword combinations.
The study selection and data extraction process
The suitability of each study was assessed in three steps. First, two authors independently reviewed the abstracts and screened and applied the selection criteria to identify suitable studies. Second, two authors independently reviewed the full text of the articles. Third, each article was analysed using the Cochrane public health group data extraction and assessment template. Suitability of selected papers for the review and meta-analysis was discussed by the whole team and disagreements were resolved by consensus.
Eligibility criteria included i) original and peer-reviewed studies written in English; ii) studies involving participants with COPD, DM, or CD who were living at home; iii) studies observing participants utilizing WDs; iv) studies related to any type of WD (the type of WD was not considered); v) studies that implemented WDs for more than two weeks with health interventions; and vi) studies that utilized a randomized controlled trial (RCT) and controlled clinical trial design. WDs in this study were defined as sensory devices that can be worn or attached to clothing and that can remotely track and monitor health information synchronously.
Exclusion criteria included i) qualitative, observational, and quasi-experimental studies; ii) pre-and post-studies without comparators; iii) prospective cohort studies; iv) studies including other chronic diseases; and v) studies involving daily monitoring without WDs or interventions of another telecommunication technology (videophones for face-to-face communication with participants at their residence or telephone support only).
Quality assessment
The risk of bias in the included studies was assessed using the Cochrane Handbook for Systematic Reviews of Intervention in six specific domains: sequence generation, allocation concealment, blinding, incomplete outcome data, selective reporting, and other bias.35 The publication bias was assessed using funnel plots.35
We included articles in the meta-analysis if they reported outcome measures for the following parameters: primary outcome – number of participants who maintained the WD for the intervention period (adherence); and secondary outcomes – number of admitted participants, weight control (more than 2% weight lost and body mass index (BMI) reduction), physical activity (walking steps/day and exercise duration), and biomarkers (fasting blood glucose (FBG) and haemoglobin A1c (HbA1c)) of participants with DM.
Statistical analysis
The meta-analysis was performed using Review Manager 5.3 software (The Nordic Cochrane Center, Copenhagen). Data were synthesized into forest plots, and a random-effect model was utilized to analyse intervention effects across all studies. The risk ratio (RR) was determined for outcome measures of dichotomous variables, and the mean difference (MD) or standard MD was calculated for continuous data. To confirm the reliability of the summary estimate, 95% confidence intervals (CIs) were calculated. The variables in each study were distilled from the data to facilitate the intention-to-treat analysis of the original group. We recorded missing data and drop-out rates for each RCT and reported the number of participants included in the meta-analysis as the reported number in the study. A sub-group analysis was performed for groups of participants diagnosed with DM, CD, or COPD. Statistical heterogeneity was analysed using the I2 statistic: I2 ≥ 50% indicates significant heterogeneity. Thus, a random-effect model was used – otherwise (i.e. I2 ≤ 49%), a fixed-effect model was used.
Results
Flow of the study selection
We found 339 studies in the database search and two studies in the manual search. Of these, the full text of 192 studies were screened and 11 RCTs met the inclusion criteria for this review (Figure 1).36–46 One RCT targeted participants with COPD,44 seven with DM,36–38,41,43,45,46 and three with CD,39,40,42 with a total of 655 participants (Table 2).

PRISMA flow diagram for article selection.
Characteristics of the reviewed articles.
WD: wearable device; RCT: randomized controlled trial; DM: diabetes mellitus; COPD: chronic obstructive pulmonary disease; BMI: body mass index; Hb: haemoglobin; M: male; F: female; SD: standard deviation; IQR: interquartile range.
Characteristics of the reviewed studies
The studies were published in six different countries including the US (n = 5),36,37,39,40,45 the UK (n = 2),38,44 the Netherlands (n = 1),43 Denmark (n = 1),42 India (n=1),46 and US–Qatar (n = 1).41 Eight RCTs36,37,39–43,46 set two arms, and three RCTs38,44,45 set three arms for intervention and control groups. The duration of the interventions varied from two weeks to six months. The types of WDs included wristbands36,37,39,40,42,43,45,46 and belts worn around the waist,38,41,44 and they tracked real-time steps,36–40,42–46 heart rate,39,40,46 physical activity,38–40,44 balance and balance training,41 and energy expenditure.38,45 Participants’ mean ages varied from 41 years36 in the DM group to 71 years44 in the COPD group. The sample size varied from a minimum of 25 participants40 to a maximum of 141,42 and nine studies had small samples with fewer than 100 participants36–41,43,44,46 (Table 2).
Types of intervention
All interventions involved the use of a WD plus an additional type of education intervention. In the DM group, educational interventions involved goal setting,36 virtual social support,36,37 motivational feedback using a social networking service or email,36–38 an electronic health (e-Health) program,43 real-time feedback,41 text message reminders,45 and diary maintenance.46 In the CD and COPD groups, the interventions involved online group discussion,39 handouts or written information,44 text messaging,40 and office visits.42 Educational interventions with WD use were compared to those that used WDs without an educational intervention or those that provided usual care without an WD as controls (Table 2).
Risk of bias in the included studies
The summary of risk of bias for each study is shown in Table 3. All studies reported randomization; however, all studies showed an uncertain risk.36–46 One study had a high risk of bias in allocation concealment39 and blinding of participants and personnel,36 and two studies had a selective reporting bias.36,37 However, the funnel plot showed no publication bias.
Risk of bias assessment in each study.
(+) = low risk of bias; (?) = uncertain risk of bias; (−) = high risk of bias.
Synthesis of results
The primary and four secondary outcomes were synthesized (Table 4). Other outcomes could not be integrated because they reported different outcome measures or did not provide standard deviation results. A meta-analysis was performed to compare use of WD with educational support versus the control group for each outcome.
Wearable device (WD) studies and reporting clinical outcomes.
Adherence of intervention
Adherence was evaluated in all of the studies,36–46 which were meta-analysed by disease sub-group. Three comparator arms of a COPD study44 and a DM study45 were integrated into two arms: WD with education intervention versus usual care group or only WD use without education. An adherence of waistbelt WD use was no different compared with the COPD group that did not use a WD (p = .80).44 In the DM group, the group that used a wristband WD36–38,41,43,45,46 were more likely to display high adherence than the group provided with a body-worn sensor belt intervention41; however, there was no significant difference (p = .31).
In the CD group, all three studies39,40,42 used a wristband WD; however, there was no significant difference in adherence between groups (p = .92). Overall, there was no significant difference between intervention and control groups in adherence (RR = 0.97; 95% CI = 0.92 to 1.03; p = .38), and no statistical heterogeneity was observed between sub-groups (I2 = 0%; Figure 2).

Forest plot of comparison for primary outcome (adherence of intervention): wearable device use plus educational support versus wearable device use only/usual care in the number of completions of intervention.
Number of admitted participants
Three RCTs39,42,44 were evaluated for the number of hospitalized participants and integrated into the meta-analysis. One study with a waist belt WD was targeted for COPD,44 and two studies with wristband WDs were targeted for CD.39,42 No difference in WD use was observed in hospitalized participants (RR = 1.33; 95% CI = 0.89 to 1.99; p = .17; I2 = 0%; Figure 3).

Forest plot of comparison for secondary outcomes (number of admitted participants): wearable device use plus educational support versus wearable device use only/usual care in the number of admitted participants during intervention.
Weight control
Two RCTs that targeted DM36,37 were evaluated for more than 2% weight loss and BMI reduction, and integrated into the meta-analysis. Both studies provided wristband WDs and set goals for weight, diet, physical activity, office visits, and weekly posting of discussion topics on a Facebook group site. Only the control group were asked to wear the WD. There was a significantly higher number of participants with a weight loss > 2% of baseline weight in the WD group that received a goal-setting education intervention (RR = 2.20; 95% CI =1.38 to 3.50; p = .0009; I2 = 0%); however, there was no difference in BMI (MD = –1.89; 95% CI = –5.20 to 1.41; p = .26; I2 = 79%; Figure 4).

Forest plot of comparison for secondary outcomes (weight control: number with > 2% weight loss and BMI): use of wearable device plus educational support versus wearable device use without education/usual care for the weight control.
Physical activity
Five RCTs37,40,41,43,45 evaluated the number of steps/day and included a meta-analysis. Most studies compared wristband/waist belt WD use with education interventions like goal setting, interactive training, text messaging, and e-Health programs. There was no significant difference between groups in number of steps/day (MD = 333.48; 95% CI = –415.83 to 1082.79; p = .38; I2 = 0%). Three studies – one for patients with DM41 and two for patients with CD39,40 – were identified concerning physical exercise duration (minutes) and meta-analysed. The DM study provided a sensor belt WD with a training program, and a CD study provided a wristband WD and conducted face-to-face weekly online groups or provided health coaching and text messaging in an intervention group. A significant difference was observed in the exercise duration in the CD sub-groups (MD = 9.53; 95% CI = 0.59 to 18.47; p = .04; I2 = 0%; Figure 5).

Forest plot of comparison for secondary outcomes (physical activity: walking steps per day and duration of physical exercise): use of wearable device plus educational support versus wearable device use only/usual care for the physical activity.
Biomarkers
Two studies37,46 that targeted DM were evaluated for FBG and HbA1c and integrated into the meta-analysis. Both studies were implemented for two to three months, provided virtual social support and coaching to increase patients’ number of steps,37 and prompted them to keep a diary.46 There were significant differences in FBG (MD = –32.39; 95% CI = –48.07 to –16.72; p < .0001; I2 = 68%) and HbA1c (MD = –0.69; 95% CI = –1.28 to –0.10; p = .02; I2 = 60%; Figure 6).

Forest plot of comparison for secondary outcomes (biomarkers: fasting blood glucose and HbA1c): use of wearable device plus educational support versus wearable device use only/usual care for the biomarkers.
Discussion
Characteristics and quality of RCTs
There were only 11 RCT studies available, and the studies were typically conducted in the US and Europe rather than in East Asian countries. The number of eligible participants was 655, which is limited. All the studies were published between 2010 and 2019. We identified a total of 69 outcomes from 11 articles in this review; however, only eight outcomes were integrated into the review because other outcomes used different measurement tools or did not provide standard deviations.
Summary of the intervention
All the reviewed studies compared the WD-use interventions and simultaneously provided educational support during said interventions. Of the two types of devices used in the studies, the wristbands seemed to result in less operational difficulty for the participants. The frequency of the WD-use intervention showed some difference; a wristband and a waist/hip belt WD was used continuously for the intervention period, and a lower-back body-worn sensor belt was used for 45-minute training sessions twice a week for four weeks. These interventions were compared to interventions with the use of WDs without an education group or only provided with usual care with no WD use.
Most RCTs set two arms for the intervention and control groups; however, the control groups comprised both no WD use and the use of WD without educational support. The educational support given to the intervention group showed some variety; thus, it was grouped into two types: “in-person education,” such as goal setting, providing handouts or written information, or visits to nurses’ offices by participants; and “electronic-style educational support,” such as virtual social support using a social network service, e-Health/mobile health (mHealth) programs, real-time feedback, and text message reminders. Therefore, the interventions in the reviewed article have the potential of clinical heterogeneity. To be safe, no adverse events were reported in the studies.
Summary of the participants
The mean age of the participants was the youngest in the DM group and the oldest in the COPD group, which showed a characteristic of the disease process. Specifically, 43% of the COPD group were readmitted to the hospital within three months before being included in the study, indicating that their prognoses may have been more unstable as compared to the other two disease groups. Furthermore, the difference in the needs for using WDs depending on the age of the participants was considered.
Summary of evidence
Selection, performance, and detection bias were considered in the studies and the quality of evidence in this review was low. This meta-analysis showed that, among the DM group, the use of WDs and goal-setting educational support over three months was more effective than only using WDs without education to reduce weight by more than 2%; and using WDs with some follow-up support implementation resulted in reduced FBG and HbA1c as compared with the group receiving usual care and not using WDs. The same result was true in the CD group concerning physical exercise duration. The results may be particularly noteworthy concerning the intervention; however, the available evidence was quite limited. For the other outcomes, we found no intervention effects on any of the primary/secondary outcomes: adherence, number of admitted participants, BMI, and steps/day. The effective intervention period, type of educational support, and disease group could not be clearly discussed in this review owing to the small number of studies.
This review concludes that the use of WDs has the potential to improve weight loss, FBG, and HbA1c for people with DM; moreover, their use may improve exercise duration in the CD group if they are provided with some educational support. As suggested by selection bias, the results may differ for different target age groups. The age of people with chronic disease was wide-ranging, and the need for self-care by using WDs was considered to be different. Moreover, in this meta-analysis, many interventions, such as class of technologies and education protocols, and many suspected comparisons make the results prone to having larger alpha errors owing to multiple comparisons. Nonetheless, the p-value for the outcomes of physical exercise duration was significant (p = .04).
Implication for home care and telemonitoring for older adults with chronic conditions
In the context of chronic disease management and the chronic care model to improve telehealth outcomes, it is indicated that not only self-management support but also design of the healthcare delivery system, decision support, clinical information system in the healthcare organization, and community resources are important.47 Therefore, using new healthcare technology such as WDs may provide benefits by adding to a new telehealth delivery system to support people with chronic disease, reinforcing their disease management. Moreover, it is important that cost, accuracy, and user-friendliness are considered before adopting this new technology, specifically for older adults who may need to use it for the rest of their lives.
Owing to the increase of life expectancy, an aging population with chronic diseases has expanded the demand for telehealth and telemonitoring. The DM group were rather young and vigorous compared to the COPD and CD groups in this review, and the type of education was adapted to each target group’s overall severity of their conditions. There are several distinct exercise recommendations, such as i) reduced sedentary time in the COPD group; ii) increased walking, weight reduction, and physical exercise in the DM group; and iii) other-device use, online discussions, or rehabilitation education for the CD group. However, the results of this review provided little evidence of the effectiveness of the use of WDs for disease management. Future studies may change these conclusions. Although the available evidence is quite limited, use of WDs provides an opportunity to utilize new technology for real-time telemonitoring of chronic conditions. Therefore, educational support to improve older adults’ telehealth outcomes by using WDs should be considered.
Limitations
We only reviewed 11 RCT studies, which were split into three disease categories; therefore, there is a risk of selection bias. The small number of participants also suggests a reporting bias. Owing to multiple comparisons of clinical and educational interventions, some of the significant pooled effects may turn out to be non-significant after statistical adjustment for multiple comparisons. Thus, the effects may have been overestimated, and it should be interpreted with caution. We could not discuss which type of educational support would be appropriate to be provided simultaneously to WD users. Moreover, available evidence of use for chronic disease management was quite limited. However, the use of WDs was demonstrated to be a useful technology with no reported harmful results.
Conclusions
Eleven RCTs with 657 participants were integrated into a meta-analysis that analysed the effectiveness of WDs used with educational support to improve adherence to healthcare guidelines and telehealth outcomes. This meta-analysis showed that, in the DM group, the use of WDs in combination with educational support was more effective than the use of only WDs with no education to reduce weight by more than 2% when delivered with educational support. Further, the use of WDs was associated with reduced FBG and HbA1c compared with regular care and no-use of a WD in the CD group. WD use with online support improved the physical exercise duration time when implemented for two to three months. However, currently, there is not enough evidence to support the use of WDs because they have not been sufficiently shown to affect telehealth outcomes for chronic disease management.
What is already known about the topic?
The WD market is rapidly growing, and it has the potential to follow information with real-time synchronization with healthcare providers and people with chronic conditions to monitor health conditions along with effective communication to manage risk factors and provide feedback for self-management. Recently, several types of wearable technology were initiated to be adopted by people with chronic conditions and were suggested to have the potential to assist in predicting clinical outcomes.
What this study adds
This meta-analysis showed that the use of WDs with educational support rather than use of WDs without education had the potential to reduce weight and improve exercise time, FBG, and HbA1c when implemented for two to three months and targeted to people with DM/CD; however, the available evidence was quite limited. Adherence and other outcomes showed no difference between wearing a device or not among people with chronic disease.
Footnotes
Acknowledgements
The authors would like to thank Ms Julie Hansen, research librarian, University of Queensland, and Ms Naoko Matsumoto, St Luke’s International University, Tokyo. This systematic review was registered to PROSPERO through the National Institute for Health Research (ID CRD42018111632). The author contributions were as follows: all authors made a direct contribution to this study; Kamei was responsible for the study concept and design, literature database search, screen, text review and data integration, and drafting the manuscript. Edirippulige carried out the database search of the literature with PI, text review and interpretation of data, critical revision of the manuscript. Kanamori was responsible for screen, text review, data extraction and integration, and critical revision of the manuscript. Yamamoto was responsible for screen, text review and data extraction of the literature, and critical revision of the manuscript. All authors approved the final version of the manuscript.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: this study was funded by the JSPS KAKENHI, Tokyo, Japan (Grant-in-Aid for Scientific Research (A) 19H01082).
