Electronic health intervention to manage symptoms of immunotherapy in patients with cancer (SOFIA): Results from a randomized controlled pilot trial.

BACKGROUND: For patients receiving immune checkpoint inhibitors, early detection of immune-related adverse events (irAEs) is critical for one's safety. To this end, a smartphone app (SOFIA) was developed that featured the assessment of electronic patient-reported outcomes (ePROs) focusing on irAEs as well as a set of comprehensive supportive information. Its feasibility and preliminary efficacy were evaluated in a randomized controlled trial (RCT). METHODS: Patients who received immune checkpoint inhibition therapy were randomly assigned to an intervention group (IG) or a control group (CG; care as usual). During the 12-week intervention period, IG patients used SOFIA to report twice weekly ePROs and receive cancer- and immunotherapy-relevant contents. Before a patient's next clinical visit, the physician in charge was given the ePRO reports. The primary objective was to test the feasibility of SOFIA. Furthermore, the preliminary efficacy of SOFIA for health-related quality of life (HRQOL), psychosocial outcomes, and medical data was examined. Clinical outcomes were assessed at baseline (T0), post-intervention (T1), and a 3-month follow-up (T2). RESULTS: Seventy-one patients were randomized to the IG (n = 34) or the CG (n = 37). SOFIA showed high feasibility and acceptance. At T1, patients in the IG reported significantly better HRQOL and role functioning and less depression, distress, and appetite loss. No significant differences were revealed regarding medical data, the utilization of supportive care services, or survival. CONCLUSIONS: SOFIA showed high feasibility and acceptance and improved HRQOL and psychosocial outcomes. These results suggest further evaluation of efficacy in a large-scale confirmatory multicenter RCT.

Incorporating nonparametric methods for estimating causal excursion effects in mobile health with zero-inflated count outcomes.

In mobile health, tailoring interventions for real-time delivery is of paramount importance. Micro-randomized trials have emerged as the "gold-standard" methodology for developing such interventions. Analyzing data from these trials provides insights into the efficacy of interventions and the potential moderation by specific covariates. The "causal excursion effect," a novel class of causal estimand, addresses these inquiries. Yet, existing research mainly focuses on continuous or binary data, leaving count data largely unexplored. The current work is motivated by the Drink Less micro-randomized trial from the UK, which focuses on a zero-inflated proximal outcome, i.e., the number of screen views in the subsequent hour following the intervention decision point. To be specific, we revisit the concept of causal excursion effect, specifically for zero-inflated count outcomes, and introduce novel estimation approaches that incorporate nonparametric techniques. Bidirectional asymptotics are established for the proposed estimators. Simulation studies are conducted to evaluate the performance of the proposed methods. As an illustration, we also implement these methods to the Drink Less trial data.

Feasibility and Accuracy of Wrist-Worn Sensors for Perioperative Monitoring During and After Major Abdominal Surgery: An Observational Study.

INTRODUCTION: Continuous, ambulatory perioperative monitoring using wearable devices has shown promise for earlier detection of physiological deterioration and postoperative complications, preventing 'failure-to-rescue'. This study aimed to compare the accuracy of vital signs measured by wrist-based wearables with gold standard measurements from vital signs monitors or nurse assessments in major abdominal surgery. METHODS: Adult patients were eligible for inclusion in this prospective observational study validating the Empatica E4 wrist sensor intraoperatively and postoperatively. The primary outcomes were the 95% limits of agreement (LoA) between manual and device recordings of heart rate (HR) and temperature evaluated via Bland-Altman analysis. Secondary analysis was conducted using Clarke-Error grid analysis. RESULTS: Overall, 31 patients were recruited, and 27 patients completed the study. The median duration of recording per patient was 70.3 h, and a total of 2112 h of data recording were completed. Wrist-based HR measurement was accurate and moderately precise (bias: 0.3 bpm; 95% LoA -15.5 to 17.1), but temperature measurement was neither accurate nor precise (bias -2.2°C; 95% LoA -6.0 to 1.6). On Clarke-Error grid analysis, 74.5% and 29.6% of HR and temperature measurements, respectively, fell within the acceptable range of reference standards. CONCLUSIONS: Continuous perioperative monitoring of HR and temperature after major abdominal surgery using wrist-based sensors is feasible but was limited in this study by low precision. While wrist-based devices offer promise for the continuous monitoring of high-risk surgical patients, current technology is inadequate. Ongoing device hardware and software innovation with robust validation is required before such technologies can be routinely adopted in clinical practice.

Real-world validation of smartphone-based photoplethysmography for rate and rhythm monitoring in atrial fibrillation.

AIMS: Photoplethysmography- (PPG) based smartphone applications facilitate heart rate and rhythm monitoring in patients with paroxysmal and persistent atrial fibrillation (AF). Despite an endorsement from the European Heart Rhythm Association, validation studies in this setting are lacking. Therefore, we evaluated the accuracy of PPG-derived heart rate and rhythm classification in subjects with an established diagnosis of AF in unsupervised real-world conditions. METHODS AND RESULTS: Fifty consecutive patients were enrolled, 4 weeks before undergoing AF ablation. Patients used a handheld single-lead electrocardiography (ECG) device and a fingertip PPG smartphone application to record 3907 heart rhythm measurements twice daily during 8 weeks. The ECG was performed immediately before and after each PPG recording and was given a diagnosis by the majority of three blinded cardiologists. A consistent ECG diagnosis was exhibited along with PPG data of sufficient quality in 3407 measurements. A single measurement exhibited good quality more often with ECG (93.2%) compared to PPG (89.5%; P < 0.001). However, PPG signal quality improved to 96.6% with repeated measurements. Photoplethysmography-based detection of AF demonstrated excellent sensitivity [98.3%; confidence interval (CI): 96.7-99.9%], specificity (99.9%; CI: 99.8-100.0%), positive predictive value (99.6%; CI: 99.1-100.0%), and negative predictive value (99.6%; CI: 99.0-100.0%). Photoplethysmography underestimated the heart rate in AF with 6.6 b.p.m. (95% CI: 5.8 b.p.m. to 7.4 b.p.m.). Bland-Altman analysis revealed increased underestimation in high heart rates. The root mean square error was 11.8 b.p.m. CONCLUSION: Smartphone applications using PPG can be used to monitor patients with AF in unsupervised real-world conditions. The accuracy of AF detection algorithms in this setting is excellent, but PPG-derived heart rate may tend to underestimate higher heart rates.

Validation of a novel smartphone-based photoplethysmographic method for ambulatory heart rhythm diagnostics: the SMARTBEATS study.

AIMS: In the current guidelines, smartphone photoplethysmography (PPG) is not recommended for diagnosis of atrial fibrillation (AF), without a confirmatory electrocardiogram (ECG) recording. Previous validation studies have been performed under supervision in healthcare settings, with limited generalizability of the results. We aim to investigate the diagnostic performance of a smartphone-PPG method in a real-world setting, with ambulatory unsupervised smartphone-PPG recordings, compared with simultaneous ECG recordings and including patients with atrial flutter (AFL). METHODS AND RESULTS: Unselected patients undergoing direct current cardioversion for treatment of AF or AFL were asked to perform 1-min heart rhythm recordings post-treatment, at least twice daily for 30 days at home, using an iPhone 7 smartphone running the CORAI Heart Monitor PPG application simultaneously with a single-lead ECG recording (KardiaMobile). Photoplethysmography and ECG recordings were read independently by two experienced readers. In total, 280 patients recorded 18 005 simultaneous PPG and ECG recordings. Sufficient quality for diagnosis was seen in 96.9% (PPG) vs. 95.1% (ECG) of the recordings (P < 0.001). Manual reading of the PPG recordings, compared with manually interpreted ECG recordings, had a sensitivity, specificity, and overall accuracy of 97.7%, 99.4%, and 98.9% with AFL recordings included and 99.0%, 99.7%, and 99.5%, respectively, with AFL recordings excluded. CONCLUSION: A novel smartphone-PPG method can be used by patients unsupervised at home to achieve accurate heart rhythm diagnostics of AF and AFL with very high sensitivity and specificity. This smartphone-PPG device can be used as an independent heart rhythm diagnostic device following cardioversion, without the requirement of confirmation with ECG.

Validation and verification framework and data integration of biosensors and in vitro diagnostic devices: a position statement of the IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MBHLM) and the IFCC Scientific Division.

Advances in technology have transformed healthcare and laboratory medicine. Biosensors have emerged as a promising technology in healthcare, providing a way to monitor human physiological parameters in a continuous, real-time, and non-intrusive manner and offering value and benefits in a wide range of applications. This position statement aims to present the current situation around biosensors, their perspectives and importantly the need to set the framework for their validation and safe use. The development of a qualification framework for biosensors should be conceptually adopted and extended to cover digitally measured biomarkers from biosensors for advancing healthcare and achieving more individualized patient management and better patient outcome.

Behavioral Activation mHealth Application for Smoking Cessation: A Randomized Controlled Pilot Trial.

BACKGROUND: Behavioral activation (BA) is an effective intervention for both depression and substance use disorders. Combining BA with a standard smoking cessation intervention may improve quit rates by addressing depressive symptoms, a key barrier to quitting. This study preliminarily evaluated the acceptability and efficacy of the BA-based Actify! mobile health application (mHealth app) for smoking cessation. METHODS: We conducted a pilot randomized controlled trial (n=242) comparing Actify! with the National Cancer Institute's (NCI) app for smoking cessation (QuitGuide) on acceptability (user satisfaction, app openings), smoking abstinence, and mechanisms of change (behavioral activation and depressive symptoms) at 8 weeks and 6 months post-randomization. Participants were US adults recruited online who smoked daily. RESULTS: Treatment satisfaction was uniformly higher in the Actify! arm. Number of app openings was similar across arms (M=34.3 openings over 8 weeks in both arms). Self-reported 30-day point prevalence abstinence (PPA) at 8 weeks was 12.6% for Actify! vs. 7.3% for QuitGuide. Differences in 30-day PPA continued through 6 months (18.5% for Actify! vs. 12.2% for QuitGuide). Changes between baseline and 8 weeks in depressive symptoms and behavioral activation favored Actify!. Planned subgroup analyses suggested greater benefit of Actify! among participants with pre-treatment mild to moderate depression symptom severity compared to those with no depression symptoms. CONCLUSIONS: Actify! showed considerable promise as a novel mHealth treatment, as evidenced by high usage and higher user satisfaction and quit rates than QuitGuide at both short- and long-term follow-up. The next step is to evaluate Actify! in a fully-powered efficacy trial. IMPLICATIONS: Study findings demonstrate the promise of a behavioral activation (BA)-based mobile health app (Actify!) for smoking cessation as a population-level intervention that can effectively address depressive symptoms as a risk factor for worse smoking treatment outcomes. The Actify! app is the first standalone BA-based app to demonstrate potential for improved acceptability and efficacy relative to a standard care comparison app, with user satisfaction and smoking quit rates descriptively exceeding those of the National Cancer Institute's QuitGuide app.

Epilepsy self-management mobile health application: A needs assessment in people with epilepsy and caregivers in Viet Nam.

OBJECTIVES: This study aimed to determine (1) the needsof Vietnamese people with epilepsy (PWE) and their caregivers for self-management mobile health applications and (2) the self-management features expected to be included in an application. METHODS: The survey consisted of an anonymous self-administered questionnaire that was distributed to PWE and caregivers from the age of 18 in Vietnam through online platforms and onsite at Nguyen Tri Phuong Hospital and University Medical Center, Ho Chi Minh City, from February 2022 to May 2022. The questionnaire assessed the participants' attitudes toward epilepsy self-management mobile applications, their willingness to use applications, and their expectations of the contents of an application. RESULTS: Responses from 103 participants were submitted. Eighty-one participants (78.6%) reported using a smartphone, but only 50.6% of those claimed to know about self-management applications. Most respondents (70.9%) thought the applications would be useful for disease self-management, and 68.9% were willing to use epilepsy self-management applications. In addition, the most expected features to be included in self-management applications were epilepsy information, seizure first aid, connecting with medical professionals, and a seizure diary. CONCLUSION: Most Vietnamese PWE and caregivers had a willingness to use epilepsy self-management applications.The expected features are related to all aspects of self-management, including information, seizure, medication, and safety management.

Chat-ePRO: Development and pilot study of an electronic patient-reported outcomes system based on ChatGPT.

OBJECTIVE: Chatbots have the potential to improve user compliance in electronic Patient-Reported Outcome (ePRO) system. Compared to rule-based chatbots, Large Language Model (LLM) offers advantages such as simplifying the development process and increasing conversational flexibility. However, there is currently a lack of practical applications of LLMs in ePRO systems. Therefore, this study utilized ChatGPT to develop the Chat-ePRO system and designed a pilot study to explore the feasibility of building an ePRO system based on LLM. MATERIALS AND METHODS: This study employed prompt engineering and offline knowledge distillation to design a dialogue algorithm and built the Chat-ePRO system on the WeChat Mini Program platform. In order to compare Chat-ePRO with the form-based ePRO and rule-based chatbot ePRO used in previous studies, we conducted a pilot study applying the three ePRO systems sequentially at the Sir Run Run Shaw Hospital to collect patients' PRO data. RESULT: Chat-ePRO is capable of correctly generating conversation based on PRO forms (success rate: 95.7 %) and accurately extracting the PRO data instantaneously from conversation (Macro-F1: 0.95). The majority of subjective evaluations from doctors (>70 %) suggest that Chat-ePRO is able to comprehend questions and consistently generate responses. Pilot study shows that Chat-ePRO demonstrates higher response rate (9/10, 90 %) and longer interaction time (10.86 s/turn) compared to the other two methods. CONCLUSION: Our study demonstrated the feasibility of utilizing algorithms such as prompt engineering to drive LLM in completing ePRO data collection tasks, and validated that the Chat-ePRO system can effectively enhance patient compliance.

The effect of personalized mobile health (mHealth) in cardiac rehabilitation for discharged elderly patients after acute myocardial infarction on their inner strength and resilience.

INTRODUCTION: Given the importance of promoting self-care and quality of life for discharged elderly patients after acute Myocardial Infarction(MI), It is necessitated we conduct interventions to promote these items. This study was conducted to determine the effect of mHealth-Cardiac rehabilitation (CR) on the inner Strength and resilience of elderly patients with MI after discharge from the hospital. METHODS: The present study was a randomized controlled trial that was conducted on 56 Elderly patients with myocardial infarction were discharged from the heart departments. In the intervention group after the patient's discharge, the patients were contacted twice a week for one month and the necessary training and support were given online. To gather data, the Mini-Mental State Examination (MMSE), the demographic and clinical characteristics questionnaire, the inner strength scale (ISS), and the Connor-Davidson Resilience Scale (CD-RISC) were completed pre- and post-intervention. The data analysis was done by SPSS16. RESULTS: This study showed the mean resilience and inner strength scores before and after the intervention in the control group had no statistically significant difference(P˃0.05). There was a significant increase in the mean resilience and inner strength scores in the intervention group after the intervention (P ≤ 0.001). CONCLUSION: The results of this study showed that mHealth as a kind of telenursing nursing has a significant effect on both variables of inner strength and resilience of post-discharge elderly patients after acute myocardial infarction. This means that using mHealth for these patients could increase the inner strength and resilience of the elderly discharged after myocardial infarction. Therefore, through using this method, elderly patients' self-care ability and quality of life could be increased.

ASTHMAXcel PRO patient satisfaction and usability field testing.

Background: ASTHMAXcel PRO, an enhanced version of the ASTHMAXcel mobile application, has been developed to deliver comprehensive, guideline-based asthma education while also facilitating the collection of patient-reported outcomes (PROs) and enhancing user experience.Objective: To perform field testing and conduct formative and summative evaluation of the ASTHMAXcel PRO application to assess its impact on patient satisfaction, usability, and usage.Methods: Twenty-eight adult patients completed a baseline visit during which ASTHMAXcel PRO was introduced, health literacy was assessed, and demographic data were collected. They were instructed to use the app for 4 weeks. The Questionnaire for User Interface Satisfaction (QUIS) and the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire were administered at baseline and 4 weeks to assess user satisfaction and technology acceptance, respectively. Semi-structured interviews were conducted to gather feedback regarding the application from patients.Results: The baseline total scores were high for both UTAUT and QUIS (mean (SD): 64.2 (10.1), 6.8 (2.2) respectively) indicating that user satisfaction and acceptance began at high levels. UTAUT total score, as well as all domain scores, improved significantly from baseline to 4 weeks (p < 0.02). QUIS total score along with several domain scores (screen, system capabilities, usability) also increased from baseline to 4-weeks (p = 0.03, 0.01, 0.03, 0.01, respectively). These improvements remained significant when adjusting for age, gender, education, and health literacy. Patients reported that the application was helpful, informative, and easy to understand and use.Conclusion: The significant increases in satisfaction and technology adoption observed among ASTHMAXcel PRO users demonstrate that the application is viable and has the potential to improve upon usability challenges faced by existing mobile health applications.

Nurse-led support impact via a mobile app for breast cancer patients after surgery: a quasi-experimental study (step 2).

Breast cancer patients may experience some health issues following surgery. Training patients about self-care plays a vital role in managing these symptoms. Mobile applications are a contemporary and appropriate approach to support patients about the potential symptoms following breast cancer surgery. This quasi-experimental study aimed to assess the impact of nurse-led support mobile application (NL-Mapp) delivered on breast cancer patients after surgery. Ninety participants were recruited, with 45 assigned to the intervention group and 45 to the control group. Subjects in the intervention group received NL-Mapp in addition to routine care, while those in the control group received only routine care over four weeks. The intervention included educational content on the postoperative period of breast cancer. Outcomes were assessed at baseline (M0), before discharge (M1), and one month after surgery (M2). The intervention group patients had significantly improved pain, affected shoulder functions, and anxiety owing to the effects of group, time, and group-time interaction. Body image and sexual adjustment were enhanced based on time and group-time interaction effects. During the follow-up period, experimental group patients experienced an improvement in body image and sexual adjustment, while those in the control group showed a decrease. This suggests that NL-Mapp may play a significant role in training breast cancer patients to manage their symptoms after surgery.

Are populations of postpartum women differentially served by community health worker programs: an observational cohort study from Zanzibar, Tanzania.

BACKGROUND: Although community health worker (CHW) programs focus on improving access to healthcare, some individuals may not receive the intended quality or quantity of an intervention. The objective of this research was to examine if certain populations of pregnant women differentially experience the implementation of a community health worker-led maternal health intervention in Zanzibar. METHODS: We included pregnant women enrolled in the Safer Deliveries (Uzazi Salama) program, which operated in 10 of 11 districts in Zanzibar, Tanzania between January 1, 2017, and June 19, 2019 (N = 33,914). The outcomes of interest were receipt of the entire postpartum intervention (three CHW visits) and time to first postpartum CHW visit (days). Visits by CHWs were done at the women's home, however, a telehealth option existed for women who were unable to be reached in-person. We conducted statistical tests to investigate the bivariate associations between our outcomes and each demographic and health characteristic. We used multivariate logistic regression to estimate the relationships between covariates and the outcomes and multivariate linear regression to estimate the association between covariates and the average time until first postpartum visit. RESULTS: Higher parity (OR = 0.85; P = 0.014; 95%CI: 0.75-0.97), unknown or unreported HIV status (OR = 0.64; p < 0.001; 95%CI: 0.53-0.78), and receipt of phone consultations (OR = 0.77; p < 0.001; 95%CI: 0.69-0.87) were associated with a lower odds of receiving all postpartum visits. Similarly, women with an unknown or unreported HIV status (estimated mean difference of 1.81 days; p < 0.001; 95%CI: 1.03-2.59) and those who received a phone consultation (estimated mean difference of 0.83 days; p < 0.001; 95%CI: 0.43-1.23), on average, experienced delays to first visit. In addition, current delivery at a referral hospital was associated with lower odds of receiving a postpartum visit and longer time to first visit compared to delivery at home, cottage hospital, PHCU + , or district hospital. Women from all other districts received their first visit earlier than women from Kaskazini B. There were no differences in the odds of receiving the entire postpartum intervention by sociodemographic variables, including age, education, and poverty assessment indicators. CONCLUSION: The results indicate no differences in intervention contact across wealth and education levels, suggesting that the program is effectively reaching women regardless of SES. However, women with other characteristics (e.g., higher parity, unknown or unreported HIV status) had lower odds of receiving the complete intervention. Overall, this work generates knowledge on existing disparities in intervention coverage and enables future programs to develop approaches to achieve equity in health care utilization and outcomes.

Dynamics of Perceived Social Isolation, Secondary Conditions, and Daily Activity Patterns Among Individuals With Stroke: A Network Analysis of Ecological Momentary Assessment Data.

OBJECTIVE: To assess contemporaneous and temporal dynamics of perceived social isolation (PSI), secondary conditions, and daily activity patterns in individuals post-stroke. DESIGN: Longitudinal observational study using ecological momentary assessment (EMA) as a real-time assessment of an individual's lived experiences. We conducted dynamic network analyses to examine longitudinal associations among EMA variables. SETTINGS: Home and Community. PARTICIPANTS: 202 individuals with mild-to-moderate chronic stroke (median age=60 years; 45% women; 44% black; 90% ischemic stroke; median NIHSS score=2; N=202). INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: EMA questions measured PSI, secondary conditions (pain, tiredness, stress, anxiety, worthlessness, difficulty concentrating, and cheerfulness), and daily activity patterns (being at home, being alone, and participating in productive activities). RESULTS: The median EMA response rate was 84%. The contemporaneous model showed that PSI was associated with being home, alone, and all symptoms except pain. The temporal model revealed a pathway indicating that feelings of worthlessness predicted PSI (regression coefficient=0.06, P=.019), followed by stress (regression coefficient=0.06, P=.024), and then by being not at home (regression coefficient=-0.04, P=.013). CONCLUSION: Implementing dynamic network analyses on EMA data can uncover dynamic connections among PSI, secondary conditions, and daily activity patterns after stroke. This study found a significant temporal association between PSI and negative emotions. Feeling isolated was followed by feeling stressed, which was followed by a tendency to be out of home, indicating adaptive behaviors in individuals with stroke. These findings highlight the importance of engaging in out-of-home or outdoor activities to mitigate PSI and negative emotions.

Contribution of MASK-air® as a mHealth tool for digitally-enabled person-centred care in rhinitis and asthma.

In chronic diseases, mobile health apps may help to (i) improve clinical management and (ii) provide valuable real-world scientific evidence. In allergic rhinitis, a market research study has only identified four mHealth apps which were multilingual, resulted in scientific publications and displayed a comprehensive list of medications. Ot those, MASK-air® was the app with the highest number of scientific publications. MASK-air® has been launched in 2015 and is currently available in 30 countries, having collected data from more than 30,000 users. It comprises a daily monitoring questionnaire, allowing patients to register (i) their daily allergy symptoms by means of visual analogue scales, and (ii) their medication use. The achievements of MASK-air® include the development of two digital biomarkers for daily monitoring of rhinitis and asthma (combined symptom-medication score and electronic daily asthma control score). In addition, MASK-air® data have allowed to assess patients' behaviours, suggesting that patients do not follow guideline recommendations, but rather treat themselves (and often use co-medication) whenever feeling worse. Using MASK-air® data, it has also been possible to quantify the impact of allergic diseases in quality-of-life, school and work productivity. MASK-air® real-world data is being used as a source of evidence for the Allergic Rhinitis and its Impact on Asthma 2024 guidelines, in an innovative process of incorporation of mobile health data into guidelines. This review discusses the clinical and scientific contributions of MASK-air® for person-centred care of rhinitis and asthma, providing an illustrative example on the use of mobile health in chronic diseases.

Peer support and mobile health for perinatal mental health: A scoping review.

BACKGROUND: Up to one in five women experience perinatal depression and/or anxiety with profound negative consequences for mothers and families. Peer support interventions have the potential to effectively prevent perinatal mental health conditions. Meanwhile, mobile health has gained popularity and plays a significant role in enhancing maternal health services. However, little is known about the availability of mobile health combined with peer support for supporting perinatal mental health. This scoping review aimed to map the relevant literature and gain insights into the available evidence on mobile health and peer support for perinatal mental health, to identify gaps and inform opportunities for future research. METHODS: A scoping review of the literature was conducted. The search strategy included five databases: CIANHL, Scopus, PsycInfo, PubMed, and ScienceDirect for the period from 2007 to 2022. RESULTS: Eight studies met the inclusion criteria, including features of online support strategies, effectiveness, and attitudes of women about peer support with mobile health. The results showed decreased depressive scores and provided a positive experience for women. Strong satisfaction with accessibility and flexibility of mobile health was found when combined with the peer support features. Additional emotional support tools (e.g., mindfulness-based activities) were likely to be acceptable to women and beneficial to mobile health. CONCLUSIONS: Understanding the context of peer support and mobile health informs the potential to support perinatal mental health. Further research in this growing area is needed to test the effectiveness of peer support in combination with mobile health intervention for supporting perinatal mental health.

The exercise-app Axia for axial spondyloarthritis enhances the home-based exercise frequency in axial spondyloarthritis patients - A cross-sectional survey.

BACKGROUND: Patients with axial spondyloarthritis (axSpA) benefit from regular home-based exercise (HbE). In spite of recommendations, a relevant proportion of German axSpA patients does not adhere to recommended HbE practices. To enhance HbE care, we developed the novel digital therapeutic (DTx) "Axia" compliant with the European medical device regulation (MDR). Axia offers a modern app-based HbE solution with patient educative content and further integrated features. OBJECTIVE: We aimed to assess Axia's efficacy, attractiveness, and functionality through a survey among axSpA-patients involved in the first user tests. METHODS: A mixed-method online questionnaire with 38 items was administered to 37 axSpA volunteers after using Axia. Numeric rating scales (NRS) and likelihood scales were primarily used. RESULTS: HbE frequency significantly increased from a median of 1 day/week to 6 days/week (p < 0.001) by using Axia. Existing HbE practitioners also increased their frequency (median of 4 days/week before, 6 days/week with Axia, p < 0.05). Axia received a median rating of 5 out of 5 stars. On NRS scales, Axia scored a median of 9 for intuitiveness and design, and a median of 8 for entertainment. 64.9% reported improved range of motion, 43.2% reported reduced pain, and 93.6% enhanced disease-specific knowledge. All users recommended Axia to other patients. CONCLUSION: Axia increases axSpA patients HbE frequency, possibly due to its good intuitiveness and design, leading to reduction in pain and subjective improvement of range of motion. This warrants further investigation in large randomized controlled interventional trials to establish its efficacy conclusively and patients adherence to HbE.

Efficacy of an individual-tailored smoking cessation intervention APP among Chinese smokers: study protocol for a randomized controlled trial.

BACKGROUND AND AIMS: Tobacco use has posed a tremendous public health problem for China. The Chinese government has taken great efforts to curb the tobacco epidemic. However, the existing smoking cessation services available in China are underused and have some limitations. Our research team intends to develop a smartphone smoking cessation application (SSC APP) and integrate it with the existing smoking cessation services. This study aims to assess the efficacy of the SSC APP developed by our research team through a randomized controlled trial (RCT). METHODS: Current smokers who are motivated to quit within 1 month (n = 1000) will be recruited both online and offline, and all potential participants will register and complete the prescreening assessment online. Participants will be randomly assigned to either the intervention group (receiving the SSC APP and a self-help smoking cessation manual) or the control group (receiving a self-help smoking cessation manual only) using a block randomization method. This study will be a two-arm, single-blind, parallel-group RCT. Participants will be followed up after enrollment through online questionnaires or by phone call. The primary outcome is self-reported 6-month continuous abstinence. The main secondary outcomes include self-reported 7-day point-prevalence abstinence at each follow-up; self-reported 3-month continuous abstinence; reduction in the number of cigarettes smoked per day; and the number of recent quit attempts. DISCUSSION: If this SSC APP proves to be effective, it could be integrated with the existing smoking cessation services and further facilitate smoking cessation at the population level in China. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2200062097, Registered July 22, 2022.

Efficacy of mobile-based educational intervention using Instructional Systems Design in promoting preventive behaviors for sexually transmitted infections among Iranian women: a randomized controlled trial.

BACKGROUND: Women who are sexually active are at risk of sexually transmitted infections (STIs), which can cause serious difficulties for their reproductive health. However, despite the high global burden of STIs, most infections are preventable with education for behavioral change. The purpose of this study is to investigate the Efficacy of Mobile-Based Educational Intervention Using Instructional Systems Design in Promoting Preventive Behaviors for Sexually Transmitted Infections among Iranian Women. METHODS: This randomized controlled trial aimed at promoting preventive behaviors related to STIs in Iranian women with an educational intervention based on the Instructional Systems Design (ISD) in 2022. The participants in this study were recruited from a single center, specifically the Health House No. 3 located in District 11 of Tehran Municipality. Two instruments were used in the present study: a) a valid scale titled: "Four-Scale of STI Preventive Behaviors", and b) a researcher-made Questionnaire titled: "Social perception affecting sexually transmitted infections (SOPESTI)". These tools contain 8 demographic items and specific questions with a total of 68 five-point Likert scales. The intervention comprised three phases: a pre-test (baseline), a training program, and two follow-up assessments (4 and 12 weeks after the start of the training program). The experimental group received education through a mobile app, while the control group received no intervention. SPSS v.26 was used, with a significance level of P < 0.05. The chi-square test, Fisher's exact test, independent t-tests, analysis of covariance (ANCOVA), and repeated measures ANOVA were used to analyze the data. RESULTS: A total of 80 women, with a mean age of 36.524 ± 6.91 (experiment group) and 34.78 ± 8.20 (control group), respectively, participated in the trial. The study revealed a statistically significant difference in the mean score for eight domains, including STIs Knowledge, STIs Vulnerability, STIs Preventive Self-efficacy, STIs Prevention intentions, STIs Perceived social exclusion, STIs Perceived cognitive barriers, STIs Perceived social support, and STIs Perceived risks in the experiment group following the intervention compared to before the intervention (p < 0.05). CONCLUSION: The results of this study showed that a mobile-based educational intervention based on the ISD model had a significant effect on the preventive behaviors of STIs in Iranian women. These results highlight the potential benefit of mobile health in enhancing reproductive health. TRIAL REGISTRATION: ClinicalTrials.gov IRCT20200602047638N1. Registered on 22 May 2021 with the IRCTID, V1.0. https://www.irct.ir/trial/55632.

Enhancing tuberculosis treatment adherence and motivation through gamified real-time mobile app utilization: a single-arm intervention study.

BACKGROUND: Finding innovative methods to enhance Tuberculosis treatment adherence in Malaysia is imperative, given the rising trend of non-adhere TB patients. Direct Observed Therapy (DOTS) has been used to ensure Tuberculosis (TB) drug compliance worldwide. However, due to its inconvenience, digitalizing this system into a virtual monitoring system via a mobile app can help deliver a more efficient tuberculosis management system. A gamified video-observed therapy is developed that connects three users the patient, supervisor, and administrator, allowing drug monitoring and patient loss to follow up with the patient tracking system. Thus, the objective of this study is to determine the impact of Gamified Real-time Video Observed Therapy (GRVOTS) mobile apps on patient medication adherence rates and motivation. METHODS: 71 patients from 18 facilities participated in the 8-week single-arm intervention study. GRVOTS mobile apps were installed in their mobile apps, and patients were expected to fulfill tasks such as providing Video Direct Observe Therapy (VDOTS) daily as well as side effect reporting. At 3-time intervals of baseline,1-month, and 2-month intervals, the number of VDOT taken, the Malaysian Medication Adherence Assessment Tool (MyMAAT), and the Intrinsic Motivation Inventory (IMI) questionnaire were collected. One-sample t-test was conducted comparing the VDOT video adherence to the standard rate of 80%. RM ANOVA was used to analyze any significant differences in MyMAAT and IMI scores across three-time intervals. RESULTS: This study involved 71 numbers of patients from 18 healthcare facilities who showed a significantly higher treatment adherence score of 90.87% than a standard score of 80% with a mean difference of 10.87(95% CI: 7.29,14.46; p < 0.001). The participants' MyMAAT and IMI scores significantly increased over 3-time intervals with the IMI Interest domain showing the highest mean difference 19.76 (95% CI: 16.37, 21.152: p < 0.001). CONCLUSIONS: By utilizing GRVOTS, a mobile application based on gamification and real-time features, we can enhance motivation and medication adherence among TB patients, while also addressing the limitations of physical DOTS. TRIAL REGISTRATION: IRCT20230308057657N1, Registered on (15/03/23).