Mobile App and Digital System for Patients after Myocardial Infarction (afterAMI): Results from a Randomized Trial.
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SUBMITTER: Krzowski B
PROVIDER: S-EPMC10145296 | biostudies-literature | 2023 Apr
REPOSITORIES: biostudies-literature
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Mobile App and Digital System for Patients after Myocardial Infarction (afterAMI): Results from a Randomized Trial.
Krzowski Bartosz B Boszko Maria M Peller Michał M Hoffman Paulina P Żurawska Natalia N Skoczylas Kamila K Osak Gabriela G Kołtowski Łukasz Ł Grabowski Marcin M Opolski Grzegorz G Balsam Paweł P
Journal of clinical medicine 20230415 8
Cardiac rehabilitation after acute myocardial infarction is crucial and improves patients' prognosis. It aims to optimize cardiovascular risk factors' control. Providing additional support via mobile applications has been previously suggested. However, data from prospective, randomized trials evaluating digital solutions are scarce. In this study, we aimed to evaluate a mobile application-afterAMI-in the clinical setting and to investigate the impact of a digitally-supported model of care in com ...[more]
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Project description:BackgroundTreatment of acute myocardial infarction has been the subject of studies over the past years. However, the initial months after myocardial infarction are crucial from the perspective of the patient's prognosis. It is extremely important to take care of all cardiovascular risk factors and undergo a full rehabilitation program. Telemedical solutions are becoming more and more relevant in everyday practice. We describe a protocol of a study evaluating the use of the mobile application "afterAMI" in patients after myocardial infarction. The app offers an educational mode, calendar, vital signs diary, medication reminders, medical history card, and healthcare professional contact panel. It offers several solutions, which individually proved to be effective and improve a patient's prognosis. Despite general promising results from previous studies regarding telemedical tools, there is a paucity of evidence when it comes to prospective randomized trials. Our aim was to perform a comprehensive evaluation of a newly developed mobile application in the clinical setting.MethodsA group of 100 patients with myocardial infarction on admission at the 1st Chair and Department of Cardiology, Medical University of Warsaw, will be recruited into the study. The project aims to assess the impact of the application-supported model of care in comparison with standard rehabilitation. At the end of the study, cardiovascular risk factors will be analyzed, along with rehospitalizations, the patients' knowledge regarding cardiovascular risk factors, returning to work, and quality of life. In this prospective, open-label, randomized, single-center study, all 100 patients will be observed for 6 months after discharge from the hospital. Endpoints will be assessed during control visits 1 and 6 months after inclusion into the study.DiscussionThis project is an example of a telemedical solution application embracing everyday clinical practices, conforming with multiple international cardiac societies' guidelines. Cardiac rehabilitation process enhancements are required to improve patients' prognosis. The evidence regarding the use of the mobile application in the described group of patients is limited and usually covers a small number of participants. The described study aims to discuss whether telemedicine use in this context is beneficial for the patients.Trial registrationClinicalTrials.gov NCT04793425 . Registered on 11 March 2021.
| S-EPMC9210045 | biostudies-literature
Project description:BackgroundThe adherence to secondary prevention treatment in patients with coronary heart disease (CHD) is low. Digital therapeutics (DTx) refers to an emerging branch of medicine that delivers medical interventions directly to patients using evidence-based, clinically evaluated, technology-based software algorithms or apps to facilitate disease management, which may be an efficient tool to optimize adherence.ObjectiveThis paper aims to investigate the effect of mobile app-based self-management DTx on long-term use of secondary prevention medications in patients with CHD in China.MethodsThis pilot study was a parallel-designed, open-labeled, single-center, randomized controlled trial. Hospitalized patients with CHD admitted to Peking University First Hospital between April 2016 and June 2017 were randomized before discharge on a 1:1 ratio. The intervention group received regular follow-up combined with DTx, which is a self-management mobile app already installed on an Android 5 (Mi Pad 1, Xiaomi Corporation) tablet. Structured data from the hospital informatics system were integrated automatically, and medication, lifestyle intervention plan, follow-up protocol, and patient education materials were also provided according to the diagnosis. Participants could use DTx for self-management at home. The control group was under conventional hospital-based follow-up care. Patients were followed up for 1 year, and the primary end point was the percentage of all guideline-recommended medications at 12 months. The secondary end points included the percentage adhered to standard secondary prevention medications at 6 months, the control rate of lipid profile, and blood pressure at 6 months and 1 year.ResultsAmong 300 randomized patients with CHD, 290 (96.7%) were included in the final analysis, including 49.3% (143/290) and 50.7% (147/290) of patients from the intervention and control groups, respectively. Baseline characteristics were similar between the 2 groups. There was a statistically significant improvement in the percentage of all guideline-recommended medications at 12 months in the intervention group compared with the control group (relative risk [RR] 1.34, 95% CI 1.12-1.61; P=.001), and there was no interaction with baseline characteristics. The intervention group had a significantly higher proportion of patients achieving blood pressure under control (systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg) and low-density lipoprotein cholesterol <1.8 mmol/L (RR 1.45, 95% CI 1.22-1.72; P<.001 and RR 1.40, 95% CI 1.11-1.75; P=.004, respectively) at 12 months. Furthermore, on logistic regression, the intervention group had a lower risk of withdrawing from guideline-recommended medications (odds ratio 0.46, 95% CI 0.27-0.78; P=.004).ConclusionsAmong patients with CHD, using a mobile app-based self-management DTx in addition to traditional care resulted in a significant improvement in guideline-recommended medication adherence at 12 months. The results of the trial will be applicable to primary care centers, especially in rural areas with less medical resources.Trial registrationClinicalTrials.gov NCT03565978; https://clinicaltrials.gov/ct2/show/NCT03565978.
| S-EPMC8889473 | biostudies-literature
Project description:BackgroundPatients with ST-elevation myocardial infarction (STEMI) not treated with primary or rescue percutaneous coronary intervention (PCI) are at risk for recurrent ischemia, especially when viability in the infarct-area is present. Therefore, an invasive strategy with PCI of the infarct-related coronary artery in patients with viability would reduce the occurrence of a composite end point of death, reinfarction, or unstable angina (UA).MethodsPatients admitted with an (sub)acute myocardial infarction, who were not treated by primary or rescue PCI, and who were stable during the first 48 hours after the acute event, were screened for the study. Eventually, we randomly assigned 216 patients with viability (demonstrated with low-dose dobutamine echocardiography) to an invasive or a conservative strategy. In the invasive strategy stenting of the infarct-related coronary artery was intended with abciximab as adjunct treatment. Seventy-five (75) patients without viability served as registry group. The primary endpoint was the composite of death from any cause, recurrent myocardial infarction (MI) and unstable angina at one year. As secondary endpoint the need for (repeat) revascularization procedures and anginal status were recorded.ResultsThe primary combined endpoint of death, recurrent MI and unstable angina was 7.5% (8/106) in the invasive group and 17.3% (19/110) in the conservative group (Hazard ratio 0.42; 95% confidence interval [CI] 0.18-0.96; p = 0.032). During follow up revascularization-procedures were performed in 6.6% (7/106) in the invasive group and 31.8% (35/110) in the conservative group (Hazard ratio 0.18; 95% CI 0.13-0.43; p < 0.0001). A low rate of recurrent ischemia was found in the non-viable group (5.4%) in comparison to the viable-conservative group (14.5%). (Hazard-ratio 0.35; 95% CI 0.17-1.00; p = 0.051).ConclusionWe demonstrated that after acute MI (treated with thrombolysis or without reperfusion therapy) patients with viability in the infarct-area benefit from a strategy of early in-hospital stenting of the infarct-related coronary artery. This treatment results in a long-term uneventful clinical course. The study confirmed the low risk of recurrent ischemia in patients without viability.Trial registrationClinicalTrials.gov: NCT00149591.
| S-EPMC3261086 | biostudies-literature
Project description:ObjectiveThis waiting-list randomized controlled trial examined the effectiveness of a self-management mHealth app in improving fatigue and quality of life (QoL) in cancer patients and survivors.MethodsPersons with cancer-related fatigue (CRF) were recruited across four English speaking countries, via social media, and randomized into intervention (n = 519) and control (n = 280) groups. Whereas the intervention group received immediate access to the Untire app, the control group received access only after 12-weeks. Primary outcomes fatigue severity and interference, and secondary outcome QoL were assessed at baseline, 4, 8, and 12-weeks. We ran generalized linear mixed models for all outcomes to determine the effects of app access (yes/no), over 12-weeks, following the intention-to-treat principle.ResultsCompared with the control group, the intervention group showed significantly larger improvements in fatigue severity (d = 0.40), fatigue interference (d = 0.35), and overall QoL on average (d = 0.32) (P's < .01), but not for overall QoL in the past week (P = .07). Sensitivity analyses indicated that participants with medium or high app use benefited most when compared with nonusers and control participants (P's ≤ .02). The intervention effect on fatigue interference was slightly stronger in younger participants (≤56 vs. >56). Effects did not depend on education and cancer status. Reliable change analyses indicated that significantly more people showed full recovery for fatigue in the intervention vs the control group (P's = .02).ConclusionsThe Untire app can be an effective mHealth solution for cancer patients and survivors with moderate to severe CRF.
| S-EPMC7756868 | biostudies-literature
Project description:ImportanceIn 2013, the Trial to Assess Chelation Therapy (TACT) reported that in 1708 patients with stable coronary disease and prior myocardial infarction (MI), oral multivitamins and multiminerals (OMVMs), in a factorial design with edetate disodium (EDTA) chelation therapy, did not reduce cardiovascular events relative to placebo OMVMs, but active EDTA combined with active OMVMs was superior to placebo OMVM/placebo EDTA.ObjectiveTo compare OMVM vs placebo in terms of efficacy for reducing major adverse cardiovascular events in patients with diabetes and prior MI.Design, setting, and participantsThe TACT2 randomized, multicenter double-masked 2 × 2 factorial clinical trial took place across 88 sites in the US and Canada. Participants were 50 years or older, had diabetes, and had an MI 6 weeks ago or more. TACT2 participants were enrolled between September 2016 and December 2020. Data were collected between October 2016 and June 2023.InterventionsSix caplets daily of a 28 component OMVM or matching OMVM placebo, and 40 weekly infusions of an EDTA-based chelation solution or matching placebo, in a 1:1:1:1 allocation ratio.Main outcomes and measuresThe primary end point was the composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina.ResultsA total of 1000 participants were randomized (500 in the active OMVM group and 500 in the placebo group). The median (IQR) age was 67 (60-72) years, and 730 (73%) were male. Median (IQR) follow-up was 48 (34-58) months. The primary end point occurred in 175 participants (35%) in the active OMVM group and 175 (35%) in the placebo group (hazard ratio [HR], 0.99 [95% CI, 0.80-1.22]; P = .92). The 5-year event rate for the primary end point in the EDTA chelation + active OMVM group was 34.0%; in the EDTA chelation + placebo OMVM group, 35.7%; in the placebo infusion + active OMVM group, 36.0%; and in the placebo infusion + placebo OMVM group, 34.3%. The comparison of the active infusion + active OMVM with the placebo infusion + placebo OMVM was not significant (HR, 0.91 [95% CI, 0.67-1.23]; P = .54). Although nonsignificant, there was a numerically higher event rate of MI, stroke, mortality from cardiovascular causes in the active OMVM compared to placebo OMVM group.Conclusions and relevanceThe results of this randomized clinical trial demonstrated that, for participants with chronic coronary disease, diabetes, and a previous MI, high-dose OMVM alone or in conjunction with EDTA-based chelation did not reduce cardiovascular events.Trial registrationClinicalTrials.gov Identifier: NCT02733185.
| S-EPMC11877407 | biostudies-literature
Project description:Rehospitalizations (RHs) after ST-elevation myocardial infarction carry a high economic burden and may deteriorate quality of life. Characterizing patients at higher risk may allow the design of preventive measures. We studied the frequency, reasons, and predictors for unplanned cardiac and noncardiac RHs in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. In this post-hoc analysis of the COMFORTABLE AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction; NCT00962416) trial including 1137 patients, unplanned cardiac and noncardiac RHs occurred in 133 (11.7%) and in 79 patients (6.9%), respectively, at 1 year. The most frequent reasons for unplanned cardiac RHs were recurrent chest pain without evidence of ischemia (20.4%), recurrent chest pain with ischemia and coronary intervention (16.9%), and ischemic events (16.9%). Unplanned noncardiac RHs occurred most frequently attributed to bleeding (24.5%), infections (14.3%), and cancer (9.1%). On multivariate analysis, left ventricular ejection fraction (22% increase in the rate of RHs per 10% decrease; P=0.03) and angiographic myocardial infarction Syntax score (34% increase per 10-point increase; P=0.01) were independent predictors of unplanned cardiac RHs. Age emerged as the only independent predictor of unplanned noncardiac RHs. Regional differences for unplanned cardiac RHs were observed. Among ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention in the setting of a randomized, clinical trial, unplanned cardiac RHs occurred in 12% with recurrent chest pain being the foremost reason. Unplanned noncardiac RHs occurred in 7% with bleeding as the leading cause. Left ventricular ejection fraction and Syntax score were independent predictors of unplanned cardiac RHs and identified patient subgroups in need for improved secondary prevention. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00962416.
| S-EPMC5586438 | biostudies-literature
Project description:BackgroundTo address the unmet need for a commercial cancer-specific meditation app, we leveraged a long-standing partnership with a consumer-based app (ie, Calm) to develop the first commercial meditation app prototype adapted specifically for the needs of patients with cancer. Input was obtained at both the individual user and clinic levels (ie, patients with and survivors of cancer and health care providers).ObjectiveThis study aimed to determine the feasibility of a cancer-specific meditation app prototype.MethodsPatients with and survivors of cancer who were recruited and enrolled in the feasibility randomized controlled trial were asked to use the prototype app daily (≥70 minutes per week) for 4 weeks. Participants completed web-based weekly questionnaires and a final poststudy questionnaire and were asked to participate in an optional web-based poststudy interview. The questionnaires and interviews covered the following feasibility categories: acceptability, demand, practicality, and adaptation.ResultsA total of 36 patients with and survivors of cancer completed the baseline questionnaire, 18 completed the final questionnaire, and 6 completed the optional interviews. Weekly and poststudy questionnaires indicated high overall enjoyment, ease of use, and satisfaction with the app content, aesthetics, and graphics. The objective use data indicated that the average total app use rate was 73.39 (SD 7.12) minutes per week. Interviews (N=6) revealed positive and mixed responses to the app prototype and informative differences related to preferences for narrators, emotional content, and meditation teaching but an overall appreciation for the variety of options.ConclusionsThe most likely candidates for moving from cancer-specific meditation apps to dissemination are through partnering with the industry, in which name recognition and market distribution are already established (even showing a base of users from the targeted population with cancer). This study established the feasibility of a cancer-specific mobile meditation app prototype for patients with and survivors of cancer, using a commercially available app. The quantitative and qualitative data demonstrated the acceptability, demand, practicality, and adaptation of the prototype. Improvements suggested by the participants will be considered in the final app design before testing the efficacy of the app in a future study.Trial registrationClinicaltrials.gov NCT05459168; https://clinicaltrials.gov/ct2/show/record/NCT05459168.
| S-EPMC9730204 | biostudies-literature
Project description:While digital health solutions continue to grow in number and in complexity, the ability for stakeholders in healthcare to easily discern quality lags far behind. This challenge is in part due to the lack of a transparent and standardized approach to validation. Evaluation of mobile health applications (apps) is further burdened by low barriers to development and direct-to-user marketing, leading to a crowded and confusing landscape. In this context, we investigated the pragmatic application of a previously described framework for digital health validation, the Digital Health Scorecard, in a cohort of 22 popular mobile health oncology apps. The apps evaluated using this framework performed poorly, scoring 49.4% across all evaluation criteria as a group. Performance across component domains varied considerably with cost scoring highest at 100%, usability at 56.7%, technical at 37.3%, and clinical at 15.9%. satisfaction of prospectively determined end-user requirements derived from patient, family, and clinician consensus scored 37.2%. While cost outperformed consistently and usability was adequate, the results also suggested that apps suffered from significant technical limitations, were of limited clinical value, and generally did not do what end users wanted. These large gaps further support the need for transparent and standardized evaluation to help all stakeholders in healthcare improve the quality of mobile health.
| S-EPMC8282811 | biostudies-literature
Project description:BackgroundThe 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM) is an instrument specially developed for the assessment of delirium in general wards, with high reported sensitivity and specificity. However, the use of the 3D-CAM by bedside nurses in routine practice showed relatively poor usability, with multiple human errors during assessment.ObjectiveThis study aimed to develop a mobile app-based delirium assessment tool based on the 3D-CAM and evaluate its usability among older patients by bedside nurses.MethodsThe Delirium Assessment Tool With Decision Support Based on the 3D-CAM (3D-DST) was developed to address existing issues of the 3D-CAM and optimize the assessment process. Following a randomized crossover design, questionnaires were used to evaluate the usability of the 3D-DST among older adults by bedside nurses. Meanwhile, the performances of both the 3D-DST and the 3D-CAM paper version, including the assessment completion rate, time required for completing the assessment, and the number of human errors made by nurses during assessment, were recorded, and their differences were compared.ResultsThe 3D-DST included 3 assessment modules, 9 evaluation interfaces, and 16 results interfaces, with built-in reminders to guide nurses in completing the delirium assessment. In the usability testing, a total of 432 delirium assessments (216 pairs) on 148 older adults were performed by 72 bedside nurses with the 3D-CAM paper version and the 3D-DST. Compared to the 3D-CAM paper version, the mean usability score was significantly higher when using the 3D-DST (4.35 vs 3.40; P<.001). The median scores of the 6 domains of the satisfactory evaluation questionnaire for nurses using the 3D-CAM paper version and the 3D-DST were above 2.83 and 4.33 points, respectively (P<.001). The average time for completing the assessment reduced by 2.1 minutes (4.4 vs 2.3 min; P<.001) when the 3D-DST was used.ConclusionsThis study demonstrated that the 3D-DST significantly improved the efficiency of delirium assessment and was considered highly acceptable by bedside nurses.
| S-EPMC10850851 | biostudies-literature
Project description:BackgroundOxygen (O2) treatment has been a cornerstone in the treatment of patients with myocardial infarction. Recent studies, however, state that supplemental O2 therapy may have no effect or harmful effects in these patients. The aim of this study was thus to evaluate the effect of O2 therapy in patients with ST Elevation Myocardial Infarction (STEMI) based on the culprit vessel; Left Anterior Descending Artery (LAD) or Non-LAD.MethodsThis was a two-center, investigator-initiated, single-blind, parallel-group, randomized controlled trial at the Skåne university hospital, Sweden. A simple computer-generated randomization was used. Patients were either randomized to standard care with O2 therapy (10 l/min) or air until the end of the primary percutaneous coronary intervention. The patients underwent a Cardiac Magnetic Resonance Imaging (CMRI) days 2-6. The main outcome measures were Myocardium at Risk (MaR), Infarct Size (IS) and Myocardial Salvage Index (MSI) as measured by CMRI, and median high-sensitive troponin T (hs-cTnT).ResultsA total of 229 patients were assessed for eligibility, and 160 of them were randomized to the oxygen or air arm. Because of primarily technical problems with the CMRI, 95 patients were included in the final analyses; 46 in the oxygen arm and 49 in the air arm. There were no significant differences between patients with LAD and Non-LAD as culprit vessel with regard to their allocation (oxygen or air) with regards to MSI, MaR, IS and hs-cTnT.ConclusionThe results indicate that the location of the culprit vessel has probably no effect on the role of supplemental oxygen therapy in STEMI patients.Trial registrationSwedish Medical Products Agency (EudraCT No. 2011-001452-11) and ClinicalTrials.gov Identifier (NCT01423929).
| S-EPMC7027294 | biostudies-literature