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Risk factors and disease profile of post-vaccination SARS-CoV-2 infection in UK users of the COVID Symptom Study app: a prospective, community-based, nested, case-control study.
Antonelli, M, Penfold, RS, Merino, J, Sudre, CH, Molteni, E, Berry, S, Canas, LS, Graham, MS, Klaser, K, Modat, M, et al
The Lancet. Infectious diseases. 2022;(1):43-55
Abstract
BACKGROUND COVID-19 vaccines show excellent efficacy in clinical trials and effectiveness in real-world data, but some people still become infected with SARS-CoV-2 after vaccination. This study aimed to identify risk factors for post-vaccination SARS-CoV-2 infection and describe the characteristics of post-vaccination illness. METHODS This prospective, community-based, nested, case-control study used self-reported data (eg, on demographics, geographical location, health risk factors, and COVID-19 test results, symptoms, and vaccinations) from UK-based, adult (≥18 years) users of the COVID Symptom Study mobile phone app. For the risk factor analysis, cases had received a first or second dose of a COVID-19 vaccine between Dec 8, 2020, and July 4, 2021; had either a positive COVID-19 test at least 14 days after their first vaccination (but before their second; cases 1) or a positive test at least 7 days after their second vaccination (cases 2); and had no positive test before vaccination. Two control groups were selected (who also had not tested positive for SARS-CoV-2 before vaccination): users reporting a negative test at least 14 days after their first vaccination but before their second (controls 1) and users reporting a negative test at least 7 days after their second vaccination (controls 2). Controls 1 and controls 2 were matched (1:1) with cases 1 and cases 2, respectively, by the date of the post-vaccination test, health-care worker status, and sex. In the disease profile analysis, we sub-selected participants from cases 1 and cases 2 who had used the app for at least 14 consecutive days after testing positive for SARS-CoV-2 (cases 3 and cases 4, respectively). Controls 3 and controls 4 were unvaccinated participants reporting a positive SARS-CoV-2 test who had used the app for at least 14 consecutive days after the test, and were matched (1:1) with cases 3 and 4, respectively, by the date of the positive test, health-care worker status, sex, body-mass index (BMI), and age. We used univariate logistic regression models (adjusted for age, BMI, and sex) to analyse the associations between risk factors and post-vaccination infection, and the associations of individual symptoms, overall disease duration, and disease severity with vaccination status. FINDINGS Between Dec 8, 2020, and July 4, 2021, 1 240 009 COVID Symptom Study app users reported a first vaccine dose, of whom 6030 (0·5%) subsequently tested positive for SARS-CoV-2 (cases 1), and 971 504 reported a second dose, of whom 2370 (0·2%) subsequently tested positive for SARS-CoV-2 (cases 2). In the risk factor analysis, frailty was associated with post-vaccination infection in older adults (≥60 years) after their first vaccine dose (odds ratio [OR] 1·93, 95% CI 1·50-2·48; p<0·0001), and individuals living in highly deprived areas had increased odds of post-vaccination infection following their first vaccine dose (OR 1·11, 95% CI 1·01-1·23; p=0·039). Individuals without obesity (BMI <30 kg/m2) had lower odds of infection following their first vaccine dose (OR 0·84, 95% CI 0·75-0·94; p=0·0030). For the disease profile analysis, 3825 users from cases 1 were included in cases 3 and 906 users from cases 2 were included in cases 4. Vaccination (compared with no vaccination) was associated with reduced odds of hospitalisation or having more than five symptoms in the first week of illness following the first or second dose, and long-duration (≥28 days) symptoms following the second dose. Almost all symptoms were reported less frequently in infected vaccinated individuals than in infected unvaccinated individuals, and vaccinated participants were more likely to be completely asymptomatic, especially if they were 60 years or older. INTERPRETATION To minimise SARS-CoV-2 infection, at-risk populations must be targeted in efforts to boost vaccine effectiveness and infection control measures. Our findings might support caution around relaxing physical distancing and other personal protective measures in the post-vaccination era, particularly around frail older adults and individuals living in more deprived areas, even if these individuals are vaccinated, and might have implications for strategies such as booster vaccinations. FUNDING ZOE, the UK Government Department of Health and Social Care, the Wellcome Trust, the UK Engineering and Physical Sciences Research Council, UK Research and Innovation London Medical Imaging and Artificial Intelligence Centre for Value Based Healthcare, the UK National Institute for Health Research, the UK Medical Research Council, the British Heart Foundation, and the Alzheimer's Society.
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Digital Health Interventions for Cardiac Rehabilitation: Systematic Literature Review.
Wongvibulsin, S, Habeos, EE, Huynh, PP, Xun, H, Shan, R, Porosnicu Rodriguez, KA, Wang, J, Gandapur, YK, Osuji, N, Shah, LM, et al
Journal of medical Internet research. 2021;(2):e18773
Abstract
BACKGROUND Cardiovascular disease (CVD) is the leading cause of death worldwide. Despite strong evidence supporting the benefits of cardiac rehabilitation (CR), over 80% of eligible patients do not participate in CR. Digital health technologies (ie, the delivery of care using the internet, wearable devices, and mobile apps) have the potential to address the challenges associated with traditional facility-based CR programs, but little is known about the comprehensiveness of these interventions to serve as digital approaches to CR. Overall, there is a lack of a systematic evaluation of the current literature on digital interventions for CR. OBJECTIVE The objective of this systematic literature review is to provide an in-depth analysis of the potential of digital health technologies to address the challenges associated with traditional CR. Through this review, we aim to summarize the current literature on digital interventions for CR, identify the key components of CR that have been successfully addressed through digital interventions, and describe the gaps in research that need to be addressed for sustainable and scalable digital CR interventions. METHODS Our strategy for identifying the primary literature pertaining to CR with digital solutions (defined as technology employed to deliver remote care beyond the use of the telephone) included a consultation with an expert in the field of digital CR and searches of the PubMed (MEDLINE), Embase, CINAHL, and Cochrane databases for original studies published from January 1990 to October 2018. RESULTS Our search returned 31 eligible studies, of which 22 were randomized controlled trials. The reviewed CR interventions primarily targeted physical activity counseling (31/31, 100%), baseline assessment (30/31, 97%), and exercise training (27/31, 87%). The most commonly used modalities were smartphones or mobile devices (20/31, 65%), web-based portals (18/31, 58%), and email-SMS (11/31, 35%). Approximately one-third of the studies addressed the CR core components of nutrition counseling, psychological management, and weight management. In contrast, less than a third of the studies addressed other CR core components, including the management of lipids, diabetes, smoking cessation, and blood pressure. CONCLUSIONS Digital technologies have the potential to increase access and participation in CR by mitigating the challenges associated with traditional, facility-based CR. However, previously evaluated interventions primarily focused on physical activity counseling and exercise training. Thus, further research is required with more comprehensive CR interventions and long-term follow-up to understand the clinical impact of digital interventions.
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A Dietary Mobile App for Patients Undergoing Hemodialysis: Prospective Pilot Study to Improve Dietary Intakes.
Fakih El Khoury, C, Crutzen, R, Schols, JMGA, Halfens, RJG, Karavetian, M
Journal of medical Internet research. 2020;(7):e17817
Abstract
BACKGROUND Mobile technology has an impact on the health care sector, also within dietetics. Mobile health (mHealth) apps may be used for dietary assessment and self-monitoring, allowing for real-time reporting of food intakes. Changing eating behaviors is quite challenging, and patients undergoing hemodialysis, particularly, struggle to meet the target intakes set by dietary guidelines. Usage of mobile apps that are developed in a person-centered approach and in line with recommendations may support both patients and health care practitioners. OBJECTIVE This study is a pilot that aims at estimating the potential efficacy of a dietary intervention using a theory-based, person-centered smartphone app. Results will be used to improve both the app and a planned large-scale trial intended to assess app efficacy thoroughly. METHODS A prospective pilot study was performed at the hemodialysis unit of Al Qassimi Hospital (The Emirate of Sharjah). All patients that fulfilled the study inclusion criteria were considered eligible to be enrolled in the pilot study. Upon successful installation of the app, users met with a dietitian once a week. Outcomes were measured at baseline (T0) and 2 weeks post app usage (T1). This pilot is reported as per guidelines for nonrandomized pilot and feasibility studies and in line with the CONSORT 2010 checklist for reporting pilot or feasibility trials. RESULTS A total of 23 patients completed the pilot intervention. Mean energy intakes increased from 24.4 kcal/kg/day (SD 8.0) to 29.1 kcal/kg/day (SD 7.8) with a medium effect size (d=0.6, 95% CI 0.0-1.2). Mean protein intakes increased from 0.9 g/kg/day (SD 0.3) to 1.3 g/kg/day (SD 0.5) with a large effect size (d=1.0, 95% CI 0.4-1.6); mean intake of high biological value (%HBV) proteins also increased from 58.6% (SD 10.1) to 70.1% (SD 10.7) with a large effect size (d=1.1, 95% CI 0.5-1.7). Dietary intakes of minerals did not change, apart from sodium which decreased from a mean intake of 2218.8 mg/day (SD 631.6) to 1895.3 mg/day (SD 581.0) with a medium effect size (d=0.5, 95% CI 0.1-1.1). Mean serum phosphorus, potassium, and albumin levels did not change relevantly. Mean serum iron increased from 7.9 mg/dL (SD 2.8) to 11.5 mg/dL (SD 7.9) postintervention with a medium effect size (d=0.6, 95% CI 0.0-1.2). CONCLUSIONS This pilot study showed that the KELA.AE app has the potential to improve dietary intakes. Processes related to procedure, resources, tools, and app improvement for a future trial were assessed. A more extended intervention using a randomized controlled trial is required to estimate parameters concerning app efficacy accurately.
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Development and Validation of an Application for Follow-up of Patients Undergoing Dialysis: NefroPortátil.
Pinto, LCS, Andrade, MC, Chaves, RO, Lopes, LLB, Maués, KG, Monteiro, AM, Nascimento, MB, Barros, CAV
Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation. 2020;(4):e51-e57
Abstract
OBJECTIVES To develop the NefroPortatil mobile application (app) and evaluate its effects on the management of patients undergoing dialysis. METHODS The first stage of the work was the development, installation, and establishment of the instructions to use the phone app as an instrument to aid in the control of fluid and food intake of 52 patients undergoing dialysis. In the second stage, the patients were monitored for 3 months and evaluated using questionnaires to measure the improvement in quality of life (Kidney Disease Quality of Life Instrument) and self-management of disease (Perceived Medical Condition Self-Management Scale) by the app. In addition, laboratory tests were performed before app use and in the first, second, and third months of its use (January to April 2018). Analysis of variance was used to analyze the laboratory data, and a paired Student's t test was used to analyze the responses to the questionnaires and as a posttest (P < .05). RESULTS Among the laboratory test results, serum phosphorus levels showed a significant difference (P < .04) after the app was used. A significant improvement was observed in self-management of the disease according to the Perceived Medical Condition Self-Management Scale questionnaire (P < .03). The usability of the app reached a median score of 9.65 from a total score of 10. CONCLUSION The NefroPortatil app improved the degree of perception of self-care of patients undergoing dialysis with chronic kidney failure, in addition to favoring nutritional control.
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Effects of the e-Motivate4Change Program on Metabolic Syndrome in Young Adults Using Health Apps and Wearable Devices: Quasi-Experimental Study.
Lee, JS, Kang, MA, Lee, SK
Journal of medical Internet research. 2020;(7):e17031
Abstract
BACKGROUND The health behaviors of young adults lag behind those of other age groups, and active health management is needed to improve health behaviors and prevent chronic diseases. In addition, developing good lifestyle habits earlier in life could reduce the risk of metabolic syndrome (MetS) later on. OBJECTIVE The aim of this study is to investigate the effects of the e-Motivate4Change program, for which health apps and wearable devices were selected based on user needs. The program was developed for the prevention and management of MetS in young adults. METHODS This experimental study used a nonequivalent control group. In total, 59 students from 2 universities in Daegu, Korea participated in the study (experimental group n=30; control group n=29). Data were collected over 4 months, from June 1 to September 30, 2018. The experimental group received a 12-week e-Motivate4Change program intervention, and the control group received MetS education and booklets without the e-Motivate4Change program intervention. RESULTS After the program, the experimental group had significantly higher scores for health-related lifestyle (t=3.86; P<.001) and self-efficacy (t=6.00; P<.001) than did the control group. Concerning BMI, there were significant effects by group (F=1.01; P<.001) and for the group × time interaction (F=4.71; P=.034). Concerning cholesterol, there were significant main effects for group (F=4.32; P=.042) and time (F=9.73; P<.001). CONCLUSIONS The e-Motivate4Change program effectively improved participants' health-related lifestyle scores and self-efficacy, and significantly reduced their BMI and cholesterol levels. The program can be used to identify and prevent MetS among young adults.
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Patient Use of Cardiovascular Devices and Apps: Are We Getting Our Money's Worth?
Aguillard, K, Garson, A
Methodist DeBakey cardiovascular journal. 2020;(4):291-295
Abstract
The evolution of technology makes it likely that a large number of people will invest in and use health-related mobile applications and wearable devices. Yet the question remains: Do these technology-based interventions modify health behavior and improve health…and are we getting our money's worth? The vast majority of studies concerning health-related apps and wearable devices have small sample sizes and short time spans of 6 months or less, so it is not clear if these durations were determined by lack of consistent use over time. Furthermore, many of the most popular applications have not been subjected to randomized trials. Overall, the small demonstrated improvements in outcomes are often associated with professional involvement from clinicians, coaches, or diabetes educators provided in conjunction with use of mobile health (mHealth) platforms. This paper explores the use of mHealth technologies that address cardiovascular disease/prevention (eg, diabetes, diet, physical activity, and associated weight loss) and discusses the lack of adequate evidence to support even minimal patient investment in mobile applications or wearable devices at this time.
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Mobile Health App With Social Media to Support Self-Management for Patients With Chronic Kidney Disease: Prospective Randomized Controlled Study.
Li, WY, Chiu, FC, Zeng, JK, Li, YW, Huang, SH, Yeh, HC, Cheng, BW, Yang, FJ
Journal of medical Internet research. 2020;(12):e19452
Abstract
BACKGROUND Chronic kidney disease (CKD) is a global health burden. Self-management plays a key role in improving modifiable risk factors. OBJECTIVE The aim of this study was to evaluate the effectiveness of wearable devices, a health management platform, and social media at improving the self-management of CKD, with the goal of establishing a new self-management intervention model. METHODS In a 90-day prospective experimental study, a total of 60 people with CKD at stages 1-4 were enrolled in the intervention group (n=30) and control group (n=30). All participants were provided with wearable devices that collected exercise-related data. All participants maintained dietary diaries using a smartphone app. All dietary and exercise information was then uploaded to a health management platform. Suggestions about diet and exercise were provided to the intervention group only, and a social media group was created to inspire the participants in the intervention group. Participants' self-efficacy and self-management questionnaire scores, Kidney Disease Quality of Life scores, body composition, and laboratory examinations before and after the intervention were compared between the intervention and control groups. RESULTS A total of 49 participants completed the study (25 in the intervention group and 24 in the control group); 74% of the participants were men and the mean age was 51.22 years. There were no differences in measured baseline characteristics between the groups except for educational background. After the intervention, the intervention group showed significantly higher scores for self-efficacy (mean 171.28, SD 22.92 vs mean 142.21, SD 26.36; P<.001) and self-management (mean 54.16, SD 6.71 vs mean 47.58, SD 6.42; P=.001). Kidney Disease Quality of Life scores were also higher in the intervention group (mean 293.16, SD 34.21 vs mean 276.37, SD 32.21; P=.02). The number of steps per day increased in the intervention group (9768.56 in week 1 and 11,389.12 in week 12). The estimated glomerular filtration rate (eGFR) of the intervention group was higher than that of the control group (mean 72.47, SD 24.28 vs mean 59.69, SD 22.25 mL/min/1.73m2; P=.03) and the decline in eGFR was significantly slower in the intervention group (-0.56 vs -4.58 mL/min/1.73m2). There were no differences in body composition between groups postintervention. CONCLUSIONS The use of wearable devices, a health management platform, and social media support not only strengthened self-efficacy and self-management but also improved quality of life and a slower eGFR decline in people with CKD at stages 1-4. These results outline a new self-management model to promote healthy lifestyle behaviors for patients with CKD. TRIAL REGISTRATION ClinicalTrials.gov NCT04617431; https://www.clinicaltrials.gov/ct2/show/NCT04617431.
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Accuracy of Nutrient Calculations Using the Consumer-Focused Online App MyFitnessPal: Validation Study.
Evenepoel, C, Clevers, E, Deroover, L, Van Loo, W, Matthys, C, Verbeke, K
Journal of medical Internet research. 2020;(10):e18237
Abstract
BACKGROUND Digital food registration via online platforms that are coupled to large food databases obviates the need for manual processing of dietary data. The reliability of such platforms depends on the quality of the associated food database. OBJECTIVE In this study, we validate the database of MyFitnessPal versus the Belgian food composition database, Nubel. METHODS After carefully given instructions, 50 participants used MyFitnessPal to each complete a 4-day dietary record 2 times (T1 and T2), with 1 month in between T1 and T2. Nutrient intake values were calculated either manually, using the food composition database Nubel, or automatically, using the database coupled to MyFitnessPal. First, nutrient values from T1 were used as a training set to develop an algorithm that defined upper limit values for energy intake, carbohydrates, fat, protein, fiber, sugar, cholesterol, and sodium. These limits were applied to the MyFitnessPal dataset extracted at T2 to remove extremely high and likely erroneous values. Original and cleaned T2 values were correlated with the Nubel calculated values. Bias was estimated using Bland-Altman plots. Finally, we simulated the impact of using MyFitnessPal for nutrient analysis instead of Nubel on the power of a study design that correlates nutrient intake to a chosen outcome variable. RESULTS Per food portion, the following upper limits were defined: 1500 kilocalories for total energy intake, 95 grams (g) for carbohydrates, 92 g for fat, 52 g for protein, 22 g for fiber, 70 g for sugar, 600 mg for cholesterol, and 3600 mg for sodium. Cleaning the dataset extracted at T2 resulted in a 2.8% rejection. Cleaned MyFitnessPal values demonstrated strong correlations with Nubel for energy intake (r=0.96), carbohydrates (r=0.90), fat (r=0.90), protein (r=0.90), fiber (r=0.80), and sugar (r=0.79), but weak correlations for cholesterol (ρ=0.51) and sodium (ρ=0.53); all P values were ≤.001. No bias was found between both methods, except for a fixed bias for fiber and a proportional bias for cholesterol. A 5-10% power loss should be taken into account when correlating energy intake and macronutrients obtained with MyFitnessPal to an outcome variable, compared to Nubel. CONCLUSIONS Dietary analysis with MyFitnessPal is accurate and efficient for total energy intake, macronutrients, sugar, and fiber, but not for cholesterol and sodium.
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Effects of Mobile Health App Interventions on Sedentary Time, Physical Activity, and Fitness in Older Adults: Systematic Review and Meta-Analysis.
Yerrakalva, D, Yerrakalva, D, Hajna, S, Griffin, S
Journal of medical Internet research. 2019;(11):e14343
Abstract
BACKGROUND High sedentary time, low physical activity (PA), and low physical fitness place older adults at increased risk of chronic diseases, functional decline, and premature mortality. Mobile health (mHealth) apps, apps that run on mobile platforms, may help promote active living. OBJECTIVE We aimed to quantify the effect of mHealth app interventions on sedentary time, PA, and fitness in older adults. METHODS We systematically searched five electronic databases for trials investigating the effects of mHealth app interventions on sedentary time, PA, and fitness among community-dwelling older adults aged 55 years and older. We calculated pooled standardized mean differences (SMDs) in these outcomes between the intervention and control groups after the intervention period. We performed a Cochrane risk of bias assessment and Grading of Recommendations, Assessment, Development, and Evaluation certainty assessment. RESULTS Overall, six trials (486 participants, 66.7% [324/486] women; age mean 68 [SD 6] years) were included (five of these trials were included in the meta-analysis). mHealth app interventions may be associated with decreases in sedentary time (SMD=-0.49; 95% CI -1.02 to 0.03), increases in PA (506 steps/day; 95% CI -80 to 1092), and increases in fitness (SMD=0.31; 95% CI -0.09 to 0.70) in trials of 3 months or shorter and with increases in PA (753 steps/day; 95% CI -147 to 1652) in trials of 6 months or longer. Risk of bias was low for all but one study. The quality of evidence was moderate for PA and sedentary time and low for fitness. CONCLUSIONS mHealth app interventions have the potential to promote changes in sedentary time and PA over the short term, but the results did not achieve statistical significance, possibly because studies were underpowered by small participant numbers. We highlight a need for larger trials with longer follow-up to clarify if apps deliver sustained clinically important effects.
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A Systematic Review of Fitness Apps and Their Potential Clinical and Sports Utility for Objective and Remote Assessment of Cardiorespiratory Fitness.
Muntaner-Mas, A, Martinez-Nicolas, A, Lavie, CJ, Blair, SN, Ross, R, Arena, R, Ortega, FB
Sports medicine (Auckland, N.Z.). 2019;(4):587-600
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Abstract
BACKGROUND Cardiorespiratory fitness (CRF) assessment provides key information regarding general health status that has high clinical utility. In addition, in the sports setting, CRF testing is needed to establish a baseline level, prescribe an individualized training program and monitor improvement in athletic performance. As such, the assessment of CRF has both clinical and sports utility. Technological advancements have led to increased digitization within healthcare and athletics. Nevertheless, further investigation is needed to enhance the validity and reliability of existing fitness apps for CRF assessment in both contexts. OBJECTIVES The present review aimed to (1) systematically review the scientific literature, examining the validity and reliability of apps designed for CRF assessment; and (2) systematically review and qualitatively score available fitness apps in the two main app markets. Lastly, this systematic review outlines evidence-based practical recommendations for developing future apps that measure CRF. DATA SOURCES The following sources were searched for relevant studies: PubMed, Web of Science®, ScopusTM, and SPORTDiscus, and data was also found within app markets (Google Play and the App Store). STUDY ELIGIBILITY CRITERIA Eligible scientific studies examined the validity and/or reliability of apps for assessing CRF through a field-based fitness test. Criteria for the app markets involved apps that estimated CRF. STUDY APPRAISAL AND SYNTHESIS METHODS The scientific literature search included four major electronic databases and the timeframe was set between 01 January 2000 and 31 October 2018. A total of 2796 articles were identified using a set of fitness-related terms, of which five articles were finally selected and included in this review. The app market search was undertaken by introducing keywords into the search engine of each app market without specified search categories. A total of 691 apps were identified using a set of fitness-related terms, of which 88 apps were finally included in the quantitative and qualitative synthesis. RESULTS Five studies focused on the scientific validity of fitness tests with apps, while only two of these focused on reliability. Four studies used a sub-maximal fitness test via apps. Out of the scientific apps reviewed, the SA-6MWTapp showed the best validity against a criterion measure (r = 0.88), whilst the InterWalk app showed the highest test-retest reliability (ICC range 0.85-0.86). LIMITATIONS Levels of evidence based on scientific validity/reliability of apps and on commercial apps could not be robustly determined due to the limited number of studies identified in the literature and the low-to-moderate quality of commercial apps. CONCLUSIONS The results from this scientific review showed that few apps have been empirically tested, and among those that have, not all were valid or reliable. In addition, commercial apps were of low-to-moderate quality, suggesting that their potential for assessing CRF has yet to be realized. Lastly, this manuscript has identified evidence-based practical recommendations that apps might potentially offer to objectively and remotely assess CRF as a complementary tool to traditional methods in the clinical and sports settings.