The INFluence of Remote monitoring on Anxiety/depRession, quality of lifE, and Device acceptance in ICD patients: a prospective, randomized, controlled, single-center trial.
Ontology highlight
ABSTRACT: Background
Impact of telemedicine with remote patient monitoring (RPM) in implantable cardioverter-defibrillator (ICD) patients on clinical outcomes has been investigated in various clinical settings with divergent results. However, role of RPM on patient-reported-outcomes (PRO) is unclear. The INFRARED-ICD trial aimed to investigate the effect of RPM in addition to standard-of-care on PRO in a mixed ICD patient cohort.Methods and results
Patients were randomized to RPM (n = 92) or standard in-office-FU (n = 88) serving as control group (CTL). At baseline and on a monthly basis over 1 year, study participants completed the EQ-5D questionnaire for the primary outcome Quality of Life (QoL), the Hospital Anxiety and Depression Scale, and the Florida Patient Acceptance Survey questionnaire for secondary outcomes. Demographic characteristics (82% men, mean age 62.3 years) and PRO at baseline were not different between RPM and CTL. Primary outcome analysis showed that additional RPM was not superior to CTL with respect to QoL over 12 months [+ 1.2 vs. + 3.9 points in CTL and RPM group, respectively (p = 0.24)]. Pre-specified analyses could not identify subgroups with improved QoL by the use of RPM. Neither levels of anxiety (- 0.4 vs. - 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM.Conclusion
The results of the present study show that PRO were not improved by RPM in addition to standard-of-care FU. Careful evaluation and planning of future trials in selected ICD patients are warranted before implementing RPM in routine practice.
SUBMITTER: Leppert F
PROVIDER: S-EPMC8166667 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundWearable devices can provide user-friendly, accurate, and continuous blood pressure (BP) monitoring to assess patients' vital signs and achieve remote patient management. Remote BP monitoring can substantially improve BP control. The newest cuffless BP monitoring devices have emerged in patient care using photoplethysmography.ObjectiveThe Senbiosys trial aims to compare BP measurements of a new device capturing a photoplethysmography signal on the finger versus invasive measurements performed in patients with an arterial catheter in the intensive care unit (ICU) or referred for a coronarography at the Hospital of Fribourg.MethodsThe Senbiosys study is a single-center, single-arm, prospective trial. The study population consists of adult patients undergoing coronarography or patients in the ICU with an arterial catheter in place. This study will enroll 35 adult patients, including 25 patients addressed for a coronarography and 10 patients in the ICU. The primary outcome is the assessment of mean bias (95% CI) for systolic BP, diastolic BP, and mean BP between noninvasive and invasive BP measurements. Secondary outcomes include a reliability index (Qualification Index) for BP epochs and count of qualified epochs.ResultsPatient recruitment started in June 2021. Results are expected to be published by December 2021.ConclusionsThe findings of the Senbiosys trial are expected to improve remote BP monitoring. The diagnosis and treatment of hypertension should benefit from these advancements.Trial registrationClinicalTrials.gov NCT04379986; https://clinicaltrials.gov/ct2/show/NCT04379986.International registered report identifier (irrid)PRR1-10.2196/30051.
| S-EPMC8532013 | biostudies-literature
Project description:BACKGROUND:Remote patient monitoring is increasingly integrated into health care delivery to expand access and increase effectiveness. Automation can add efficiency to remote monitoring, but patient acceptance of automated tools is critical for success. From 2010 to 2013, the Diabetes-Depression Care-management Adoption Trial (DCAT)-a quasi-experimental comparative effectiveness research trial aimed at accelerating the adoption of collaborative depression care in a safety-net health care system-tested a fully automated telephonic assessment (ATA) depression monitoring system serving low-income patients with diabetes. OBJECTIVE:The aim of this study was to determine patient acceptance of ATA calls over time, and to identify factors predicting long-term patient acceptance of ATA calls. METHODS:We conducted two analyses using data from the DCAT technology-facilitated care arm, in which for 12 months the ATA system periodically assessed depression symptoms, monitored treatment adherence, prompted self-care behaviors, and inquired about patients' needs for provider contact. Patients received assessments at 6, 12, and 18 months using Likert-scale measures of willingness to use ATA calls, preferred mode of reach, perceived ease of use, usefulness, nonintrusiveness, privacy/security, and long-term usefulness. For the first analysis (patient acceptance over time), we computed descriptive statistics of these measures. In the second analysis (predictive factors), we collapsed patients into two groups: those reporting "high" versus "low" willingness to use ATA calls. To compare them, we used independent t tests for continuous variables and Pearson chi-square tests for categorical variables. Next, we jointly entered independent factors found to be significantly associated with 18-month willingness to use ATA calls at the univariate level into a logistic regression model with backward selection to identify predictive factors. We performed a final logistic regression model with the identified significant predictive factors and reported the odds ratio estimates and 95% confidence intervals. RESULTS:At 6 and 12 months, respectively, 89.6% (69/77) and 63.7% (49/77) of patients "agreed" or "strongly agreed" that they would be willing to use ATA calls in the future. At 18 months, 51.0% (64/125) of patients perceived ATA calls as useful and 59.7% (46/77) were willing to use the technology. Moreover, in the first 6 months, most patients reported that ATA calls felt private/secure (75.9%, 82/108) and were easy to use (86.2%, 94/109), useful (65.1%, 71/109), and nonintrusive (87.2%, 95/109). Perceived usefulness, however, decreased to 54.1% (59/109) in the second 6 months of the trial. Factors predicting willingness to use ATA calls at the 18-month follow-up were perceived privacy/security and long-term perceived usefulness of ATA calls. No patient characteristics were significant predictors of long-term acceptance. CONCLUSIONS:In the short term, patients are generally accepting of ATA calls for depression monitoring, with ATA call design and the care management intervention being primary factors influencing patient acceptance. Acceptance over the long term requires that the system be perceived as private/secure, and that it be constantly useful for patients' needs of awareness of feelings, self-care reminders, and connectivity with health care providers. TRIAL REGISTRATION:ClinicalTrials.gov NCT01781013; https://clinicaltrials.gov/ct2/show/NCT01781013 (Archived by WebCite at http://www.webcitation.org/6e7NGku56).
| S-EPMC4736285 | biostudies-literature
Project description:BackgroundImplantable cardioverter defibrillator (ICD) acceptance and shock anxiety are issues that clinicians should address to improve quality of life among device recipients. Previous findings have indicated that younger patients experience poorer device adjustment. The purpose of this study was to examine age and ICD-specific quality-of-life outcomes in a large sample of Canadian ICD patients. We tested the hypothesis that patient age is related to device acceptance and shock anxiety in an Alberta (Canada) ICD population.MethodsThe Florida Patient Acceptance Survey (FPAS) and Florida Shock Acceptance Survey (FSAS) were completed by ICD patients attending the Cardiac Implantable Electrical Device Clinics in Alberta. The population was dichotomized into those aged ≤ 65 years (younger) and those aged > 65 years (older). Sex, ICD shock history, and remote monitoring use were also examined.ResultsSurveys were completed by 126 younger (53 ± 11 years; 79% male) and 216 older (74 ± 6 years; 85% male) patients. Younger, compared with older, patients had greater device-related distress (P < 0.001) and more body-image concerns (P < 0.001), but no differences in return to function or positive appraisal. Younger patients reported lower total device acceptance (P = 0.001) and greater total shock anxiety (P < 0.001) compared with older patients.ConclusionsICD patients aged ≤ 65 years reported poorer device acceptance and greater shock anxiety than older patients. Younger patients may require targeted interventions addressing adjustment to the ICD, and impact of the ICD on body image. Moreover, education about the relatively low probability of shocks may alleviate shock anxiety in younger patients.
| S-EPMC7710939 | biostudies-literature
Project description:The aim was to assess the association between objectified preoperative psychological factors and postoperative pain at the first day after otolaryngological surgery in accordance with other predictors of postoperative pain. Eighty-two (82) patients (59% male, median age 56 years) were included between January and May 2015. The psychological assessment the day before surgery included the Patient Health Questionnaire (PHQ-9), pain catastrophizing scale (PCS), State-Trait Operation Anxiety (STOA) inventory, and the resilience scale (RS-13). On first postoperative day, patients were rated their pain using the questionnaires of the German-wide project Quality Improvement in Postoperative Pain Treatment (QUIPS) including a numeric rating scale (NRS, 0-10) for determination of patient's maximal pain. QUIPS allowed standardized assessment of patients' characteristics, pain parameters, and outcome. The influence of preoperative and postoperative parameters on patients' maximal postoperative pain was estimated by univariate and multivariate statistical analysis. The mean maximal pain was 3.2?±?2.9. In univariate analysis, higher PHQ-9 score more than 4 (P = 0.010), higher STOA trait anxiety (P = 0.044), and higher STOA total score (P = 0.043) were associated to more postoperative pain. In multivariate analysis higher PHQ-9 score remained an independent predictor for severe pain (beta = 0.302; 95% confidence interval [CI]: 0.054-0.473; P = 0.014). When all parameters were included into multivariate analysis, 2 of all somatic, psychological, and treatment factors were associated with severe maximal pain: more depression (PHQ-9; beta = 0.256; 95% CI: 0.042-0.404; P = 0.017), and use of opioids in the recovery room (beta = 0.371; 95% CI: 0.108-0.481; P = 0.002). Otolaryngological surgery covers the spectrum from low to severe postoperative pain and is therefore a good model for pain management studies. A set of somatic and psychological parameters seems to allow the identification of patients with higher risk for more postoperative pain. This should help to individualize and improve the perioperative pain management.
| S-EPMC4956830 | biostudies-other
Project description:Periodontal treatment could be worsened by risk factors. Depression and anxiety have been suggested as potentially influencing periodontal treatment outcomes. The aim of this study was to determine their association with non-surgical periodontal treatment outcomes in patients with generalized severe periodontitis (stage III/IV generalized periodontitis) at 6 months. A total of 68 patients diagnosed with generalized severe periodontitis were treated with scaling and root planing (SRP) and were followed at 3 and 6 months. The data of the 54 patients that followed the entire protocol were considered for analysis. Depression and anxiety levels were determined at baseline by the Beck Depression Inventory (BDI) and State-Trait Inventory (STAI) questionnaires. The association between psychological scores and periodontal parameters was evaluated by multivariate analysis. At 3 and 6 months, SRP induced an improvement for all periodontal parameters (plaque index (PI), bleeding on probing (BOP), periodontal probing depth (PPD) and clinical attachment loss (CAL)). BDI and STAI scores were associated with the evolution of PI, BOP, mean PPD and number of sites with PPD > 3 mm and with CAL > 3 mm. Depression and anxiety should be considered as risk factors for SRP and the identification of at-risk patients should be performed using well-established tools.
| S-EPMC8431014 | biostudies-literature
Project description:BackgroundTelemedicine technology is a growing field, especially in the context of the COVID-19 pandemic. Consult Station (Health for Development) is the first telemedicine device enabling completely remote medical consultations, including the concurrent collection of clinical parameters and videos.ObjectiveOur aim was to collect data on the multisite urban and suburban implementation of the Consult Station for primary care and assess its contribution to health care pathways in areas with a low density of medical services.MethodsIn a proof-of-concept multisite prospective cohort study, 2134 consecutive patients had teleconsultations. Consultation characteristics were analyzed from both the patient and practitioner perspective.ResultsIn this study, the main users of Consult Station were younger women consulting for low-severity seasonal infections. Interestingly, hypertension, diabetes, and preventive medical consultations were almost absent, while they accounted for almost 50% of consultations with a general practitioner (GP). We showed that for all regions where the Consult Station was implemented, the number of consultations increased as GP density decreased. The study of practitioner characteristics showed GPs from metropolitan areas are motivated to work with this device remotely, with a high level of technology acceptability.ConclusionsThe multisite implementation of Consult Station booths is suitable for primary care and could also address the challenge of "medical deserts." In addition, further studies should be performed to evaluate the possible contribution of Consult Station booths to limiting work absenteeism.
| S-EPMC9157322 | biostudies-literature
Project description:BACKGROUND:Monitoring mental health outcomes has traditionally been based on heuristic decisions, often based on scarce, subjective evidence, making the clinical decisions made by professionals, as well as the monitoring of these diseases, subject to flaws. However, the digital phenotype, which refers to the analysis of data collected by measuring human behavior with mobile sensors and smart bracelets, is a promising tool for filling this gap in current clinical practice. OBJECTIVE:The objectives of this study are to develop the digital phenotyping of patients with alcohol use disorder and anxiety symptoms using data collected from a mobile device (ie, smartphone) and a wearable sensor (ie, Fitbit) and to analyze usability and patient satisfaction with the data collection service provided by the app. METHODS:We propose to conduct a study among a group of 60 participants split into two subgroups-experimental and control-of 30 participants each. The experimental group will be recruited by physicians from the Hospital Clínic de Barcelona, and the control group will be recruited on a volunteer basis through fliers and social media. All participants will go through pretraining to ensure technological capability and understanding of tasks, then each participant will download the HumanITcare app and will be given a wearable sensor (ie, Fitbit). Throughout the 4-month period, participants will be monitored on a range of factors, including sleep cycle, heart rate, movement patterns, and sociability. All data from the wearable sensors and the mobile devices will be saved and sent to the HumanITcare server. Participants will be asked to complete weekly questionnaires about anxiety, depression, and alcohol use disorder symptoms. Research assistants will ensure timely responses. The data from both sensors will then be compared to the questionnaire responses to determine how accurately the devices can predict the same symptoms. RESULTS:The recruitment phase was completed in November 2019 and all the data were collected by the end of December 2019. Data are being processed; this process is expected to be completed by October 2020. CONCLUSIONS:This study was created and conducted as a pilot study with the Hospital Clínic de Barcelona, with the purpose of exploring the feasibility of our approach. The study is focused on patients diagnosed with anxiety and alcohol use disorder, but participants were also monitored for depressive symptoms throughout the trial, although these were not part of the initial inclusion criteria. A limitation to our study was the exclusive use of Android smartphones over iOS devices; this could result in a potential selection bias, due to the accessibility and affordability of Android phones as opposed to iOS-based phones. Another limitation might be that reviews of usability and satisfaction could be confounded by factors such as age and familiarity. An additional function that we might add in future studies is the ability for patients to manage their own data. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16964.
| S-EPMC7381016 | biostudies-literature
Project description:AimsRemote monitoring of patients with physiological data derived from cardiac implanted electronic devices (CIEDs) offers potential to reconfigure clinical services. The 'Heart Failure Risk Score' (HFRS) uses input from integrated device physiological monitoring to risk-stratify patients as low-risk, medium-risk, or high-risk of a heart failure event in the next 30 days. This study aimed to evaluate a novel clinical pathway utilizing a combination of CIED risk-stratification and telephone triage to identify patients with worsening heart failure (WHF).Methods and resultsA prospective, single-centre, real-world evaluation of the 'Triage-HF Plus' clinical pathway (HFRS in combination with telephone triage) over a 27 month period. One hundred and fifty-seven high-risk HFRS transmissions were referred for telephone triage assessment. Interventions were at the discretion of the clinical assessor acting in accordance with clinical guidelines. An additional 3month consecutive sample of low and medium HFRS transmissions (control group) were also contacted for telephone triage assessment (n = 98). Successful telephone contact was made in 127 (81%) of referred high-risk HFRS cases: 71 (55.9%) were confirmed to have WHF requiring intervention; 19 (14.9%) had an alternative acute medical problem; one patient had been recently discharged from hospital with WHF; and 36 (28.0%) had no apparent cause for the high score. In the control group, only one patient had symptoms of WHF. The sensitivity and specificity of CIED-based remote monitoring to identify WHF 98.6% (92.5-100.0%) and 63.4% (55.2-71.0%), respectively.ConclusionsThe Triage-HF Plus clinical pathway is a potentially useful remote monitoring tool for patients with heart failure and in situ CIEDs.
| S-EPMC7083434 | biostudies-literature
Project description:Given the unalterable nature of most risk factors for colorectal cancer (CRC) survival (e.g., disease stage), identifying modifiable determinants is critical. We investigated whether anxiety and depression were related to CRC survival using data from the Nurses' Health Study (NHS) and Health Professional Follow-up Study (HPFS). Participants who received a CRC diagnosis and provided information about anxiety (nNHS = 335; nHPFS = 232) and depression (nNHS = 893; nHPFS = 272) within 4 years of diagnosis were included. Cox regression models estimated hazard ratios (HR) and 95% confidence intervals (CI) of overall mortality, while controlling for covariates (sociodemographics, cancer characteristics, and lifestyle factors). Pooled risk estimates were derived from fixed effects meta-analyses of the cohorts. Among 1732 CRC patients, 814 deaths occurred during the 28-year follow-up. Each 1 standard deviation increase in anxiety or depression symptoms was associated with a similar 16% higher mortality risk (anxiety: 95% CI = 1.05-1.29; depression: 95% CI = 1.07-1.26). Comparable results were observed across all sensitivity analyses (introducing a 1-year lag, restricting to CRC-related mortality, considering potential behavioral pathways) and stratified models (cancer stage, sex). Our findings suggest greater anxiety and depression symptoms can not only impede adherence to healthy habits and reduce quality of life in cancer patients but could also be a marker for accelerated CRC progression.
| S-EPMC7599619 | biostudies-literature
Project description:ObjectiveLanguage patterns may elucidate mechanisms of mental health conditions. To inform underlying theory and risk models, we evaluated prospective associations between in vivo text messaging language and differential symptoms of depression, generalized anxiety, and social anxiety.MethodsOver 16 weeks, we collected outgoing text messages from 335 adults. Using Linguistic Inquiry and Word Count (LIWC), NRC Emotion Lexicon, and previously established depression and stress dictionaries, we evaluated the degree to which language features predict symptoms of depression, generalized anxiety, or social anxiety the following week using hierarchical linear models. To isolate the specificity of language effects, we also controlled for the effects of the two other symptom types.ResultsWe found significant relationships of language features, including personal pronouns, negative emotion, cognitive and biological processes, and informal language, with common mental health conditions, including depression, generalized anxiety, and social anxiety (ps < .05). There was substantial overlap between language features and the three mental health outcomes. However, after controlling for other symptoms in the models, depressive symptoms were uniquely negatively associated with language about anticipation, trust, social processes, and affiliation (βs: -.10 to -.09, ps < .05), whereas generalized anxiety symptoms were positively linked with these same language features (βs: .12-.13, ps < .001). Social anxiety symptoms were uniquely associated with anger, sexual language, and swearing (βs: .12-.13, ps < .05).ConclusionLanguage that confers both common (e.g., personal pronouns and negative emotion) and specific (e.g., affiliation, anticipation, trust, and anger) risk for affective disorders is perceptible in prior week text messages, holding promise for understanding cognitive-behavioral mechanisms and tailoring digital interventions.
| S-EPMC9729432 | biostudies-literature