Dataset Information

Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study.

ABSTRACT: BACKGROUND:Thyrotoxicosis is a common disease caused by an excess of thyroid hormones. The prevalence of thyrotoxicosis about 2% and 70-90% of thyrotoxicosis cases are caused by Graves' disease, an autoimmune disease, which has a high recurrence rate when treated with antithyroid drugs such as methimazole or propylthiouracil. The clinical symptoms and signs of thyrotoxicosis include palpitation, weight loss, restlessness, and difficulty sleeping. Although these clinical changes in thyrotoxicosis can be detected by currently available wearable activity trackers, there have been few trials of the clinical application of wearable devices in patients with thyrotoxicosis. OBJECTIVE:The aim of this study is to investigate the clinical applicability of wearable device-generated data to the management of thyrotoxicosis. We are analyzing continuously monitored data for heart rate, physical activity, and sleep in patients with thyrotoxicosis during their clinical course after treatment. METHODS:Thirty thyrotoxic patients and 10 control subjects were enrolled in this study at Seoul National University Bundang Hospital. Heart rate, physical activity, and sleep are being monitored using a Fitbit Charge HR or Fitbit Charge 2. Clinical data including anthropometric measures, thyroid function test, and hyperthyroidism symptom scale are recorded. RESULTS:Study enrollment began in December 2016, and the intervention and follow-up phases are ongoing. The results of the data analysis are expected to be available by September 2017. CONCLUSIONS:This study will provide a foundational feasibility trial of the clinical applications of biosignal measurements to the differential diagnosis, prediction of clinical course, early detection of recurrence, and treatment in patients with thyrotoxicosis. TRIAL REGISTRATION:ClinicalTrials.gov NCT03009357; https://clinicaltrials.gov/ct2/show/NCT03009357 (Archived by WebCite at http://www.webcitation.org/6wh4MWPm2).

SUBMITTER: Lee JE

PROVIDER: S-EPMC5842324 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study.

Lee Jie-Eun JE Lee Dong Hwa DH Oh Tae Jung TJ Kim Kyoung Min KM Choi Sung Hee SH Lim Soo S Park Young Joo YJ Park Do Joon DJ Jang Hak Chul HC Moon Jae Hoon JH

JMIR research protocols 20180221 2

<h4>Background</h4>Thyrotoxicosis is a common disease caused by an excess of thyroid hormones. The prevalence of thyrotoxicosis about 2% and 70-90% of thyrotoxicosis cases are caused by Graves' disease, an autoimmune disease, which has a high recurrence rate when treated with antithyroid drugs such as methimazole or propylthiouracil. The clinical symptoms and signs of thyrotoxicosis include palpitation, weight loss, restlessness, and difficulty sleeping. Although these clinical changes in thyrot ...[more]

PMID: 29467121

Similar Datasets

Project description:BackgroundSymptoms and signs of thyrotoxicosis are nonspecific and assessing its clinical status is difficult with conventional physical examinations and history taking. Increased heart rate (HR) is one of the easiest signs to quantify this, and current wearable devices can monitor HR.ObjectiveWe assessed the association between thyroid function and resting HR measured by a wearable activity tracker (WD-rHR) and evaluated the clinical feasibility of using this method in patients with thyrotoxicosis.MethodsThirty patients with thyrotoxicosis and 10 controls were included in the study. Participants were instructed to use the wearable activity tracker during the study period so that activity and HR data could be collected. The primary study outcomes were verification of changes in WD-rHR during thyrotoxicosis treatment and associations between WD-rHR and thyroid function. Linear and logistic model generalized estimating equation analyses were performed and the results were compared to conventionally obtained resting HR during clinic visits (on-site resting HR) and the Hyperthyroidism Symptom Scale.ResultsWD-rHR was higher in thyrotoxic patients than in the control groups and decreased in association with improvement of thyrotoxicosis. A one standard deviation-increase of WD-rHR of about 11 beats per minute (bpm) was associated with the increase of serum free T4 levels (beta=.492, 95% CI 0.367-0.616, P<.001) and thyrotoxicosis risk (odds ratio [OR] 3.840, 95% CI 2.113-6.978, P<.001). Although the Hyperthyroidism Symptom Scale showed similar results with WD-rHR, a 1 SD-increase of on-site rHR (about 16 beats per minute) showed a relatively lower beta and OR (beta=.396, 95% CI 0.204-0.588, P<.001; OR 2.114, 95% CI 1.365-3.273, P<.001) compared with WD-rHR.ConclusionsHeart rate data measured by a wearable device showed reasonable predictability of thyroid function. This simple, easy-to-measure parameter is clinically feasible and has the potential to manage thyroid dysfunction.Trial registrationClinicalTrials.gov NCT03009357; https://clinicaltrials.gov/ct2/show/NCT03009357 (Archived by WebCite at http://www.webcitation.org/70h55Llyg).

Project description:BackgroundThe proliferation and popularity of wearable activity trackers (eg, Fitbit, Jawbone, Misfit) may present an opportunity to integrate such technology into physical activity interventions. While several systematic reviews have reported intervention effects of using wearable activity trackers on adults' physical activity levels, none to date have focused specifically on children and adolescents.ObjectiveThe aim of this review was to examine the effectiveness of wearable activity trackers as a tool for increasing children's and adolescents' physical activity levels. We also examined the feasibility of using such technology in younger populations (age range 5-19 years).MethodsWe conducted a systematic search of 5 electronic databases, reference lists, and personal archives to identify articles published up until August 2016 that met the inclusion criteria. Articles were included if they (1) specifically examined the use of a wearable device within an intervention or a feasibility study; (2) included participants aged 5-19 years old; (3) had a measure of physical activity as an outcome variable for intervention studies; (4) reported process data concerning the feasibility of the device in feasibility studies; and (5) were published in English. Data were analyzed in August 2016.ResultsIn total, we identified and analyzed 5 studies (3 intervention, 2 feasibility). Intervention delivery ranged from 19 days to 3 months, with only 1 study using a randomized controlled trial design. Wearable activity trackers were typically combined with other intervention approaches such as goal setting and researcher feedback. While intervention effects were generally positive, the reported differences were largely nonsignificant. The feasibility studies indicated that monitor comfort and design and feedback features were important factors to children and adolescents.ConclusionsThere is a paucity of research concerning the effectiveness and feasibility of wearable activity trackers as a tool for increasing children's and adolescents' physical activity levels. While there are some preliminary data to suggest these devices may have the potential to increase activity levels through self-monitoring and goal setting in the short term, more research is needed to establish longer-term effects on behavior.

Project description:BackgroundChildhood cancer survivors are at increased risk of cardiometabolic complications that are exacerbated by poor health behaviors. Critically, many survivors do not meet physical activity guidelines.ObjectiveThe primary aim was to evaluate the feasibility and acceptability of iBounce, a digital health intervention for educating and engaging survivors in physical activity. Our secondary aims were to assess the change in survivors' physical activity levels and behaviors, aerobic fitness, and health-related quality of life (HRQoL) after participating in the iBounce program.MethodsWe recruited survivors aged 8 to 13 years who were ≥12 months post cancer treatment completion. The app-based program involved 10 educational modules, goal setting, and home-based physical activities monitored using an activity tracker. We assessed objective physical activity levels and behaviors using cluster analysis, aerobic fitness, and HRQoL at baseline and after the intervention (week 12). Parents were trained to reassess aerobic fitness at home at follow-up (week 24).ResultsIn total, 30 participants opted in, of whom 27 (90%) completed baseline assessments, and 23 (77%) commenced iBounce. Our opt-in rate was 59% (30/51), and most (19/23, 83%) of the survivors completed the intervention. More than half (13/23, 57%) of the survivors completed all 10 modules (median 10, IQR 4-10). We achieved a high retention rate (19/27, 70%) and activity tracker compliance (15/19, 79%), and there were no intervention-related adverse events. Survivors reported high satisfaction with iBounce (median enjoyment score 75%; ease-of-use score 86%), but lower satisfaction with the activity tracker (median enjoyment score 60%). Parents reported the program activities to be acceptable (median score 70%), and their overall satisfaction was 60%, potentially because of technological difficulties that resulted in the program becoming disjointed. We did not observe any significant changes in physical activity levels or HRQoL at week 12. Our subgroup analysis for changes in physical activity behaviors in participants (n=11) revealed five cluster groups: most active, active, moderately active, occasionally active, and least active. Of these 11 survivors, 3 (27%) moved to a more active cluster group, highlighting their engagement in more frequent and sustained bouts of moderate-to-vigorous physical activity; 6 (56%) stayed in the same cluster; and 2 (18%) moved to a less active cluster. The survivors' mean aerobic fitness percentiles increased after completing iBounce (change +17, 95% CI 1.7-32.1; P=.03) but not at follow-up (P=.39).ConclusionsWe demonstrated iBounce to be feasible for delivery and acceptable among survivors, despite some technical difficulties. The distance-delivered format provides an opportunity to engage survivors in physical activity at home and may address barriers to care, particularly for regional or remote families. We will use these pilot findings to evaluate an updated version of iBounce.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12621000259842; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12621000259842.

Project description:Rationale & objectivePeople receiving hemodialysis often require urgent care or hospitalizations. It is possible that reductions in a patient's level of physical activity may serve as an "early warning" of clinical deterioration, allowing timely clinical intervention. We explored whether step count could serve as a trigger for deterioration.Study designProspective observational cohort feasibility study.Setting & participantsWe recruited consenting adult participants from outpatient dialysis clinics in Calgary, AB, between June 28, 2019, and October 10, 2019.Exposure and outcomesParticipants wore a wristband fitness tracker for 4 weeks. Activity data from the trackers were imported weekly into the study database. Demographic, clinical management, functional impairment, and frailty were assessed at baseline. Clinical events (urgent care and emergency department visits and hospitalizations) were monitored during the observation period.Analytical approachBox and whisker plots and line plots were used to describe each participant's daily steps. Adjusted rate ratios (and 95 % confidence intervals) were calculated to assess the associations between the number of steps taken each day and potential predictors.ResultsData from 46 patients were included; their median age was 64 years (range, 22 to 85), and 63 % were men. The median number of steps taken per day was 3,133 (range, 248-13,753). Fourteen events among 11 patients were reported. Within patients, step count varied considerably; it was not possible to identify a patient-specific normal range for daily step count. There was no association between step count and the occurrence of clinical events, although the number of events was very small.LimitationsThe number of participants was relatively small, and there were too few events to model to examine whether step count could predict clinical deterioration.ConclusionsWithin-patient variation in daily step count was too high to generate a normal range for patients. However, patient-specific norms over a longer period (3- or 7-day periods) appear potentially worthy of future study in a larger sample and/or over a longer follow-up.

Dataset Information

Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study.

Publications

Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets