JMIR mHealth and uHealth

Association Between Intradialytic Foot Temperature Gradients and Severe Peripheral Artery Disease in Patients Undergoing Hemodialysis: Prospective Cohort Study

2026-11-06T16:30:21-05:00

Background: Peripheral artery disease (PAD) is prevalent in hemodialysis (HD) patients but remains difficult to diagnose due to unreliable ankle-brachial index (ABI) measurements caused by vascular calcification. We hypothesized that monitoring foot temperatures and their changes during HD, provoked by hemodynamic shifts, could serve as a novel diagnostic tool for detecting severe PAD. Objective: This study aims to evaluate the diagnostic utility of intradialytic foot temperature monitoring using wearable mobile health (mHealth) sensors for detecting severe PAD in patients undergoing HD. Methods: In this prospective observational study, we recruited 109 patients undergoing chronic maintenance HD. Skin temperatures were monitored continuously at the instep and sole during HD sessions using wearable sensors (Temp Pal, iWEECARE Co, Ltd), which are wireless, nanochip-based mHealth thermometers with ±0.05 °C accuracy. The diagnostic performance of temperature parameters, specifically the temperature difference between the wrist and foot at the end of HD, was evaluated against vascular duplex ultrasound (DUS). Severe PAD was defined as abnormal (monophasic or absent) flow in the distal posterior tibial artery (PTA) or anterior tibial artery (ATA). Results: Patients with abnormal tibial flow on DUS exhibited significantly different temperature gradients between the wrist and foot at the end of dialysis compared to those with normal flow. Receiver operating characteristic (ROC) analysis demonstrated that the wrist-foot temperature difference at the sole effectively discriminated abnormal ATA flow (area under the curve [AUC] 64.5%, 95% CI 57.8%‐70.9%) and abnormal PTA flow (AUC 62.0%, 95% CI 55.2%‐68.5%). Notably, an instep wrist-foot temperature difference cutoff of –2.2 °C or less yielded a specificity of 97.6% (95% CI 94.0%-99.3%) for detecting abnormal PTA flow. Conclusions: Intradialytic foot temperature monitoring, particularly the temperature gradient between the wrist and foot, significantly correlates with severe tibial artery flow abnormalities. This method offers an accessible, noninvasive screening adjunct to the ABI for detecting severe PAD in the HD population. These findings indicate an association rather than a standalone diagnostic test; given the modest discriminative ability, external validation is warranted.

Patient Engagement in a Virtual Cardiac Rehabilitation Platform: Secondary Analysis of the ERA-Nudge Trial

2026-11-06T16:30:21-05:00

Background: Mobile health interventions have the potential to motivate healthy behaviors. Optimal strategies for engaging patients in cardiac rehabilitation (CR) through mobile health interventions remain unclear. Objective: This study aimed to examine patient engagement in a mobile app platform for CR across patient characteristics and by the method of delivery of nudge messages over the 12 weeks of CR. Methods: The authors analyzed data from the ERA-Nudge (Enhancing Rehabilitation Adherence Through Optimized Nudge) study, a pragmatic randomized trial conducted at an urban safety-net hospital testing nudges (short messages designed using behavioral economics to elicit behavior change) to enhance CR adherence and log healthy activity. Trial patients were given access to a smartphone-based app. Nudges were initially sent as app notifications. Later in the study, patients received nudges as text messages. We assessed patient characteristics associated with app engagement, and we compared time spent in the CR app among patients receiving nudges as app notifications vs text messages. The trial enrolled patients who could engage with messages in either English or Spanish at an urban safety-net hospital with a qualifying CR diagnosis and a smartphone from May 2019 to May 2023. We describe minutes spent in the app across patient characteristics and by type of nudge delivery, and we compare the 2 approaches using unadjusted and multivariate negative binomial regression over the 12 weeks of CR. Results: In total, 223 patients received nudges: 74 via app notification and 149 via text message. Overall, patients spent an average of 219 (SD 328) minutes in the app, and 3 (1.3%) patients used the app for zero minutes. Patients receiving only app nudges spent a mean of 167 (SD 365) minutes in the app, and patients receiving text messages and app nudges spent 245 (SD 306) minutes in the app (unadjusted ratio 1.5, 95% CI 1.1-2.0; =.02). After adjusting for age category, sex, primary language, CR location (hospital vs home), and highest education achieved, Spanish-preferring patients, patients with some college education, and patients receiving text messages spent more time in the app. Patients receiving nudges as text messages and app notifications spent an adjusted ratio of 1.8 (95% CI 1.2-2.5; =.002) times as many minutes in the app compared to those getting nudges as app notifications. Conclusions: Among an urban safety-net population, text message nudges were associated with greater time in the app compared to nudges delivered as app notifications. These findings suggest that text messages may result in greater patient engagement for mobile health interventions. Trial Registration: ClinicalTrials.gov NCT03834155; https://clinicaltrials.gov/study/NCT03834155 International Registered Report Identifier (IRRID): RR2-10.1016/j.ahj.2025.05.010

Effectiveness of a Multicomponent Digital Therapeutic Program on Inhaled Medication Adherence in Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial

2026-11-06T14:15:10-05:00

Background: Poor medication adherence is a critical impediment to effective chronic obstructive pulmonary disease (COPD) management and remains challenging to track in routine care. Digital therapeutic interventions may improve chronic disease management through remote monitoring and patient education. However, most existing digital interventions focus on individual components of disease management, and evidence from longer-term pragmatic randomized controlled trials evaluating integrated digital therapeutics in routine clinical practice remains limited. Objective: This study aimed to evaluate the effectiveness of a multicomponent digital therapeutic program combining electronic inhaler monitoring (EIM) with behavioral support in improving medication adherence and symptom-related outcomes among patients with COPD prescribed pressurized metered-dose inhalers, and to assess patient engagement and implementation in routine clinical practice. Methods: In this prospective, open-label, unblinded, randomized controlled trial, patients with COPD prescribed pressurized metered-dose inhalers were enrolled and randomized in a 2:1 ratio to either the intervention group or the control group. All participants received an EIM device to objectively record inhaler use throughout the 24-week study period. Patients in the intervention group also received personalized medication reminders from the EIM, adherence feedback, educational content, and clinician-supported follow-up through an integrated digital management platform based on EIM-derived data, whereas the control group received usual care. The primary outcome was medication adherence over 24 weeks. Secondary outcomes included exacerbations, COPD symptoms, quality of life, and lung function. Results: A total of 158 participants were randomized, including 106 in the intervention group and 52 in the control group. The median monitoring coverage was 161.5 (IQR 86.3‐168.0) days during the follow-up period. The self-reported adherence measured using the Test of Adherence to Inhalers showed no significant between-group differences at any follow-up time point. However, the electronically monitored adherence was significantly higher in the intervention group than in the control group (59.5% vs 33.1%, =.009). Adherence declined over time in both groups, decreasing from 85.3% during weeks 0 to 4 to 43.0% during weeks 12 to 24 in the intervention group and from 76.8% to 11.9% in the control group over the same intervals, resulting in a progressively larger between-group difference over follow-up. No significant differences were observed in exacerbations, health-related quality of life, symptom burden, lung function, or mental health outcomes. In an exploratory analysis, a significantly greater proportion of participants in the intervention group achieved the minimal clinically important difference in the COPD Assessment Test score than in the control group (odds ratio 2.21, 95% CI 1.11‐4.41; =.02). Conclusions: The multicomponent digital therapeutic program significantly improved objective medication adherence in patients with COPD over 24 weeks. While most clinical outcomes did not differ significantly between groups, the higher proportion of participants achieving a clinically meaningful improvement in the COPD Assessment Test score warrants further investigation. Trial Registration: ClinicalTrials.gov NCT05667363; https://clinicaltrials.gov/study/NCT05667363

Measuring Perceived Stress in Healthy Adults in Daily Life: Scoping Review of Smartphone-Based Self-Assessment

2026-11-05T16:00:02-05:00

Background: Smartphone-based self-assessment methods, such as ecological momentary assessment (EMA), are increasingly used to measure perceived stress in research and emerging clinical applications. However, the proliferation of studies and methods has made it difficult for researchers and practitioners to maintain an overview and make informed methodological choices. An updated synthesis of smartphone-based self-report methods is therefore needed. Objective: This scoping review aims to systematically map smartphone-based methods for assessing self-reported perceived stress in healthy adults during daily life, to describe measurement characteristics and methodological choices, and to narratively examine the extent to which validity and reliability evidence are reported. Methods: Following PRISMA‑ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, we searched a total of 7 databases: Web of Science, Embase, MEDLINE, PubMed, IEEE Xplore, ACM, and PsycInfo. Eligible studies assessed general perceived stress in healthy adults using smartphone-based self-report measures in daily life. Screening was conducted independently by at least 2 reviewers at the abstract and full‑text levels. Methodological characteristics of stress measurement were extracted and summarized descriptively. Results: From 8777 deduplicated records, 108 studies met all eligibility criteria. Publication frequency increased notably over the review period. Most studies used observational designs, with EMA-style prompting schedules. Stress was typically assessed using very brief measures: most instruments (84/114, 74%) consisted of a single item, most commonly answered using a Likert-type scale or a visual analog scale. Measurement frequency ranged from once per week to multiple prompts per day, with intensive approaches (≥3 prompts per day) being most common. Despite the prevalence of these instruments, only a minority of studies reported validity or reliability measures. When provided, evidence typically consisted of correlations with established stress questionnaires or affective measures. A small subset conducted elaborate psychometric analyses or validation of instruments. Conclusions: Smartphone-based stress assessment is widespread but methodologically heterogeneous. This review provides an updated methodological overview to support researchers in selecting or developing robust smartphone-based measures of perceived stress. Only a small minority of studies reported formal psychometric evaluations, highlighting the need for more systematic validation of smartphone-based stress assessment. Trial Registration: OSF Registries 7UM6B; https://osf.io/7um6b

CogniPaz, an Ecologically Oriented Gamified mHealth Tool for Detecting Mild Cognitive Impairment: Prospective Cohort Diagnostic Accuracy Study

2026-11-04T17:45:20-05:00

Background: Discriminating mild cognitive impairment (MCI) from subjective cognitive decline (SCD), and healthy controls (HC) remains challenging. Digital tools may overcome paper-and-pencil screening’s limitations. Objective: This study evaluated the diagnostic accuracy and usability of CogniPaz (Daniel Blanco), an ecologically oriented, mobile health (mHealth), gamified cognitive assessment tool exploring memory and executive functions, in discriminating MCI (particularly amnestic phenotypes [aMCI]) from SCD, and HC. Methods: This prospective observational study recruited a convenience sample of consecutive patients with cognitive complaints and HC at La Paz University Hospital Cognitive Disorders Unit from April 2025 to January 2026. Demographic and clinical characteristics, and Montreal Cognitive Assessment (MoCA) scores were collected. An evaluator blinded to the MoCA scores oversaw the automated, self-administered CogniPaz assessment. Participants were classified into HC (no cognitive complaints, MoCA score≥26), SCD (cognitive complaints, MoCA score≥26), and MCI (cognitive complaints without functional impairment, MoCA score<26, subdivided into amnestic [aMCI] and nonamnestic phenotypes). Receiver operating characteristic (ROC) analyses using age-adjusted models, the DeLong test, and bootstrap validation evaluated diagnostic accuracy across groups. The correlation between MoCA and CogniPaz scores was assessed using Spearman rank correlation. Participants with available biomarker data underwent exploratory analysis of CogniPaz’s ability to detect biologically confirmed any-cause neurodegeneration (bND). Usability was tested using an ad hoc Likert questionnaire (1‐9 points). Results: The participants (n=84, 57.1% female; median age 72.0, IQR 62.5-77.0 years) included 27 HC, 17 with SCD, 22 with aMCI, and 18 with nonamnestic MCI. The aMCI group was older than the SCD group (age: median 76.5, IQR 70.8-78.8 vs median 59.0, IQR 50.0-69.0 years; Kruskal-Wallis/Dunn, =.003). CogniPaz scores correlated with MoCA scores (ρ0.81, 95% CI 0.75‐0.89; .001). CogniPaz showed good concurrent accuracy, independently of age: MCI vs HC (area under the curve [AUC]=0.880, 95% CI 0.798‐0.961), MCI vs SCD (AUC=0.915, 95% CI 0.841‐0.990), aMCI vs HC (AUC=0.910, 95% CI 0.830‐0.990), and aMCI vs SCD (AUC=0.943, 95% CI 0.878‐1.000). At the provisional <28.5 cutoff point, sensitivity ranged from 85.0% (34/40, 95% CI 70.2‐94.3) to 90.9% (20/22, 95% CI 70.8‐98.9) and specificity from 74.1% (20/27, 95% CI 53.7‐88.9) to 82.4% (14/17, 95% CI 56.6‐96.2) across comparisons. CogniPaz suggested capacity to detect bND (AUC=0.810, 95% CI 0.661‐0.958), with potential incremental value over MoCA and age (odds ratio [OR]=0.78, 95% CI 0.60‐0.94; =.02). Median administration time was 9.39 (IQR 7.53‐11.38) minutes with 100% (84/84) completion. User satisfaction was high (median score 8.4/9, IQR 7.9‐8.6; Cronbach α=0.84). Conclusions: CogniPaz is an innovative, user-friendly mHealth tool that addresses classical cognitive screening tools’ limitations through a brief, multidomain, minimally supervised gamified format, with high patient acceptance. It correlates with MoCA scores, shows good concurrent capacity to differentiate MCI, particularly aMCI, from SCD and HC, and appears promising for identifying bND. Pending external longitudinal validation, these findings support CogniPaz as a candidate for early cognitive screening in primary care.

Co-Designed Text Messaging Intervention for Parents of Children With Early Childhood Caries: Randomized Controlled Trial

2026-11-03T16:45:20-05:00

Background: Early childhood caries (ECC) is a prevalent yet preventable disease that significantly impacts young children’s health and quality of life. The World Health Organization’s highlights the potential of mobile health programs to enhance engagement and support sustained oral health behavior change. Objective: The aim of this study was to assess the effectiveness of the SmilesUp 12-week SMS text messaging–based education and support program to improve parents’ management of their children’s oral health behaviors compared to standard clinical care. Methods: We conducted a multisite, assessor-blinded, parallel-design randomized controlled trial among parents of children aged 0 to 6 years who had an ECC diagnosis and attended 1 of 6 public dental clinics in metropolitan, regional, and rural New South Wales, Australia. Participants were randomly assigned to either an intervention group receiving the fully automated 12-week SmilesUp program (3 SMS text messages weekly) or a control group. Both groups continued to receive usual standard dental clinical treatment. The primary behavioral outcome was parent-reported twice-daily toothbrushing with fluoride toothpaste. Secondary outcomes included adherence to oral health–promoting bedtime routines and child consumption of sugar-sweetened foods and beverages. Oral health self-efficacy was measured using 6 behavioral theory–mapped items across oral hygiene, diet, and bedtime routines. Results: A total of 154 participants were enrolled and randomized (n=78, 50.6% in the control group; n=76, 49.4% in the intervention group) across 6 sites, with 80.5% (124/154) completing the follow-up assessment. High program adherence was observed, with 96.1% (73/76) of intervention participants completing the program. At 12 weeks, a greater proportion of SmilesUp participants reported brushing their children’s teeth twice daily (45/61, 73.8% vs 42/63, 66.7%; adjusted odds ratio [aOR] 2.45, 95% CI 0.95-6.74; =.07), though this difference was not statistically significant. Significant improvements were observed in adherence to bedtime routines (54/61, 88.5% vs 45/63, 71.4%; aOR 3.25, 95% CI 1.15-10.18; =.03) as well as oral health knowledge on toothbrushing (46/50, 92.0% vs 41/52, 78.8%; aOR 5.47, 95% CI 1.48-25.19; =.02). No statistically significant differences were found in sugar-sweetened food (10/61, 16.4% vs 4/63, 6.3%; aOR 3.72, 95% CI 1.02-17.14; =.06) or beverage (25/61, 41.0% vs. 27/63, 42.9%; aOR 1.08, 95% CI 0.49-2.30; =.85) consumption. Conclusions: These findings suggest that co-designed SMS text messaging–based programs show promise and may represent a feasible strategy for oral health behavior change. However, larger-scale and longer-term studies are needed to confirm sustained effectiveness using clinical outcomes. Future research should also explore ways mobile health can be scaled and cost-effectively embedded into comprehensive, interdisciplinary primary models of care. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12623000325606; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12623000325606 International Registered Report Identifier (IRRID): RR2-10.1371/journal.pone.0310561

Multidomain Outcomes of a Digital Self-Management Program in Rural Adults With Chronic Conditions: Single-Arm Prospective Interventional Study

2026-10-30T13:00:28-04:00

Background: Chronic disease and comorbid mental health problems disproportionately affect rural and underserved populations. Digital self-management programs are potentially scalable, but evaluations often focus on narrow outcomes. Objective: This study examined 12-month longitudinal changes in psychological and multidomain outcomes among Pictou County Patient Empowerment Program participants and explored co-occurring changes and psychological moderators. Methods: This single-arm prospective interventional study enrolled 182 community-dwelling adults with ≥1 chronic condition in Pictou County, Nova Scotia, between October 2023 and August 2025 through community-based outreach. Median age was 60 (IQR 51‐68) years, 155 of 182 (85.2%) participants were women, and the median number of chronic conditions was 3 (IQR 1‐3). The initial 6-month digital intervention delivered brief daily modules targeting physical activity, nutrition, stress regulation, sleep, habit formation, and social connection, followed by a 6-month lower-intensity maintenance period during which monthly group videoconference sessions continued to be offered. Outcomes were assessed at baseline, 6 months, and 12 months. Primary outcomes were illness perceptions (Brief Illness Perception Questionnaire), perceived stress (10-item Perceived Stress Scale [PSS-10]), disease-related worry (10-item Questionnaire on Distress in Cancer Patients), life satisfaction (Satisfaction With Life Scale), and mental well-being (World Health Organization-Five Well-Being Index [WHO-5]). Secondary outcomes assessed the physical, behavioral, and psychosocial domains. Generalized estimating equations estimated population-averaged longitudinal changes, adjusted for age, sex, relationship status, comorbidity burden, and baseline depression or anxiety medication use. Exploratory models examined co-occurring changes and moderation. Tests were 2-sided with =.05. Results: Across outcomes and follow-up assessments, completion ranged from 58.2% (95% CI 51.0%-65.2%; 106/182) to 65.4% (95% CI 58.2%‐71.9%; 119/182). At 12 months, illness perceptions decreased (β=−7.3, 95% CI −9.7 to −4.9), perceived stress decreased (β=−2.4, 95% CI −3.5 to −1.3), disease-related worry decreased (β=−6.3, 95% CI −7.8 to −4.7), life satisfaction increased (β=2.5, 95% CI 1.4‐3.5), and mental well-being increased (β=10.4, 95% CI 7.2‐13.5; all <.001). Secondary outcomes improved across fatigue, sleep, diet quality, sedentary behavior, spiritual well-being, mental health–related quality of life, weight, and BMI. Exploratory analyses showed that improvements in fatigue, sleep quality, and illness perceptions co-occurred with greater well-being and life satisfaction and lower perceived stress and disease-related worry at both follow-up assessment points. Clinically meaningful stress improvement (≥4-point PSS-10 reduction) was achieved by 36.4% (95% CI 27.3%-45.6%, 39/107) and 43.4% (95% CI 34.0%-52.8%, 46/106) participants at 6 and 12 months, respectively. At 12 months, 43.5% (95% CI 34.2%-52.9%, 47/108) participants reported clinically meaningful improvement in mental well-being (≥10-point WHO-5 increase). Conclusions: Participation in this low-bandwidth, home-based digital self-management program was associated with sustained psychological, physical, and behavioral improvements among rural adults with chronic conditions. These multidomain findings support randomized controlled evaluation of scalable digital self-management approaches as adjuncts to rural chronic disease care. Trial Registration: ClinicalTrials.gov NCT06064110; https://clinicaltrials.gov/study/NCT06064110

Real-World Functional Gait Recovery Trajectories After Total Hip and Total Knee Arthroplasty via Smartphone Sensors: Observational Longitudinal Study

2026-10-30T11:45:18-04:00

Background: Recovery after total hip arthroplasty (THA) and total knee arthroplasty (TKA) is typically assessed with infrequent clinic-based evaluations that may not reflect patients’ everyday mobility. Smartphone inertial sensors enable scalable, repeated gait measurement in real-world settings, but the extent to which prompted walking tests reflect daily life walking during recovery is not well defined. Objective: The objective of this study was to characterize week-by-week recovery trajectories after THA and TKA using high-frequency smartphone sensor data and quantify the difference between prompted in-app walking tests and passive daily life background walking. Methods: We analyzed longitudinal smartphone-based gait measurements from 735 patients (THA, n=350; TKA, n=385) who underwent unilateral surgery between July 2022 and October 2025. Nine spatiotemporal gait parameters were monitored over the first 15 postoperative weeks across 2 conditions: prompted “in-app” walks and passively captured “background” walks. Recovery trajectories were evaluated using Kaplan-Meier time-to-baseline analyses, linear mixed-effects models, and comparison of late-stage plateau levels (weeks 11‐15) using estimated marginal means of the models. Results: Across all parameters, THA patients returned to preoperative baseline levels faster than TKA patients, with mean trajectories generally approaching baseline by week 4 for THA versus weeks 6 to 8 for TKA. Linear mixed-effects models showed that surgical procedure type significantly influenced recovery trajectory for all parameters except single support of the unaffected leg. All gait parameters except stance asymmetry and single support of the unaffected leg exhibited persistent differences through the late-recovery plateau (weeks 11‐15). We also compared prompted “in-app” walks with passively captured background walking. Prompted and passive walking showed systematic divergence in both THA and TKA; prompted assessments generally indicated faster or more complete return to baseline than passive daily life walking. Finally, preoperative gait level was strongly associated with postoperative trajectories, with baseline-stratified analyses showing distinct patterns of recovery between groups. Conclusions: High-frequency smartphone gait assessment quantifies procedure-specific recovery dynamics and demonstrates that prompted tests and passive daily life measurements capture distinct, noninterchangeable functional signals. Parameters from prompted walks plateaued while those from passively captured walks were still changing; prompted testing alone therefore captures only one component of returning function, highlighting the additional information that passive, real-world gait monitoring can provide.

The Mediating Role of Sleep Quality in Associations of Smartphone Addiction and Time-Specific Use With Prenatal Depression and Anxiety: Cross-Sectional Observational Study

2026-10-30T10:30:12-04:00

Background: Prenatal depression and anxiety have emerged as pressing global public health challenges. In the digital era, excessive smartphone use may exert complex effects on maternal mental health. Prior research has predominantly focused on adolescents, whereas evidence among pregnant women, particularly regarding total weekly use and use during critical circadian windows, such as after waking and before bedtime, remains limited. Furthermore, the mediating role of sleep quality in these associations has yet to be systematically examined. Objective: This study aimed to investigate the associations of smartphone addiction and time-specific smartphone use with prenatal depression and anxiety, and to assess the mediating role of sleep quality in these associations. Methods: This cross-sectional observational study enrolled 537 pregnant women. Smartphone use characteristics, sleep quality, and prenatal depression and anxiety were assessed using the Smartphone Addiction Scale-Short Version (SAS-SV), objective total weekly smartphone use recorded by the device, and self-reported duration of smartphone use after waking and duration of bedtime smartphone use; the Pittsburgh Sleep Quality Index (PSQI), the Patient Health Questionnaire-9 (PHQ-9), and the Generalized Anxiety Disorder-7 (GAD-7), respectively. Binary logistic regression was used to estimate associations, restricted cubic spline (RCS) models were used to explore nonlinear patterns, and exploratory mediation analyses were used to examine whether sleep quality statistically accounted for part of the observed associations. Results: The prevalence of moderate-to-severe prenatal depression and anxiety was 8.8% (47/537) and 5.8% (31/537), respectively. After adjusting for covariates, smartphone addiction was associated with higher odds of depression (odds ratio [OR] 3.461, 95% CI 1.771‐7.100) and anxiety (OR 7.738, 95% CI 3.064‐23.172). Duration of smartphone use after waking ≥61 minutes and duration of bedtime smartphone use ≥91 minutes were also associated with higher odds of affective disorders. RCS analyses further revealed distinct nonlinear patterns across different exposure dimensions: duration of smartphone use after waking displayed U-shaped and J-shaped associations with depression and anxiety, respectively, while total weekly use displayed a U-shaped association with anxiety. Exploratory mediation analyses showed that the indirect pathways through sleep quality were statistically significant for the associations of bedtime smartphone use, weekly smartphone use, and smartphone addiction with prenatal depression, with mediation proportions of 44.89% (0.0065/0.0145), 31.30% (0.0056/0.0183), and 31.48% (0.0415/0.1315), respectively. The corresponding proportions in the anxiety models were 35.83% (0.0044/0.0123), 27.05% (0.0039/0.0144), and 22.73% (0.0271/0.1187). Conclusions: Smartphone addiction and excessive smartphone use after waking and before bedtime were associated with higher odds of prenatal depression and anxiety. Sleep quality may statistically account for part of these associations, but longitudinal studies are needed to establish temporal ordering and causal pathways.

Effectiveness of Wrist-Worn Wearable–Guided Cardiac Rehabilitation Delivered Through Fully Remote or Hybrid Programs in Patients With Cardiovascular Disease: Systematic Review and Meta-Analysis of Randomized Controlled Trials

2026-10-27T14:00:03-04:00

Background: Cardiovascular disease (CVD) remains the leading cause of death worldwide, yet participation in cardiac rehabilitation (CR) remains suboptimal. Wrist-worn wearables may support fully remote or hybrid CR through activity monitoring and individualized feedback, but the effectiveness and consistency of benefits remain uncertain. Objective: This study aimed to evaluate the effectiveness of wrist-worn wearable–guided CR delivered through fully remote or hybrid programs initiated during phase II or III CR in patients with CVD. Methods: A total of 8 databases were searched for randomized controlled trials published from January 1, 2015, through August 7, 2026. Eligible trials enrolled adults with CVD and integrated a wrist-worn wearable into fully remote or hybrid CR. Studies focused primarily on heart failure or using wearables only for outcome measurement were excluded. Primary outcomes were peak oxygen consumption (VO₂), 6-minute walk distance (6MWD), and daily steps. Random-effects meta-analyses used mean differences (MDs), except for quality of life, which used standardized MDs. Between-study variance was estimated using the DerSimonian-Laird method, pooled-effect CIs used the Knapp-Hartung adjustment, and 95% prediction intervals (PIs) used the Nagashima-Noma-Furukawa parametric bootstrap method. Risk of bias was assessed with Cochrane Risk of Bias 2. Subgroup and univariable meta-regression analyses explored study and intervention characteristics. Results: A total of 18 trials involving 1993 randomized participants, reported in 20 publications, were included; 17 contributed to meta-analysis. Pooled estimates favored wearable-guided CR for peak VO₂ (10 studies; 591 participants; MD 1.69, 95% CI 0.46-2.92, 95% PI –2.21 to 5.39 mL/kg/min), 6MWD (9 studies; 1094 participants; MD 31.03, 95% CI 7.66-53.92, 95% PI –62.11 to 123.18 m), and daily steps (8 studies; 474 participants; MD 1062.8, 95% CI 383.5-1825.0, 95% PI –503.0 to 2860.0 steps/day). All 3 PIs included the null, indicating uncertainty about consistency across future comparable settings. No clear pooled effects were observed for anaerobic threshold, BMI, waist circumference, grip strength, or quality of life. Subgroup differences were not statistically significant. In univariable meta-regression, a higher proportion of female participants was associated with greater peak VO₂ improvement, although this aggregate-level finding was exploratory. Conclusions: Wrist-worn wearable–guided CR delivered through fully remote or hybrid programs may improve average exercise capacity and physical activity in patients with CVD. However, PIs included the null, indicating uncertainty about consistency across future settings. These programs may extend activity monitoring, individualized feedback, and behavioral support beyond center-based CR, but their multicomponent nature prevents attributing effects to wearables alone. Larger, rigorously designed trials with standardized protocols and outcomes should identify the patients and program components most likely to benefit. Future research should also evaluate long-term adherence, safety, equity, and implementation within routine multidisciplinary CR across diverse health systems.