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In this pilot study, the authors investigated the preliminary effectiveness of the digital lifestyle intervention, actensio (mementor DE GmbH), in treating arterial hypertension. Adults with arterial hypertension were randomly assigned to an intervention group (actensio + standard care) or a control group (waiting list + standard care) in a 1:1 ratio. Primary and secondary endpoints were assessed at baseline (t0) and 3 months post-randomization (t1). The primary endpoint was average systolic blood pressure, measured at home for 1 week. Secondary endpoints included patient engagement (measured using the "patient activation measure"; PAM-13), average diastolic blood pressure, and heart rate. All endpoints were analyzed using ANCOVA models, following an intention-to-treat approach, while adjusting for baseline values. Missing data were estimated using multiple imputation models. A total of N = 102 participants (f = 59, age = 52.94 ± 9.01) were randomized to either the intervention (IG; N = 52) or the control group (CG; N = 50), of which N = 80 completed the blood pressure diary, and N = 81 the PAM-13 at t1. Between-group comparisons showed an average group difference in systolic blood pressure of -5.06 mm Hg (95% CI = -8.71 to -1.41, p = .013) between the intervention group (M = 137.37 ± 10.13) and the control group (M = 142.35 ± 11.23). Average group difference for patient engagement was 3.35 points with a trend towards statistical significance (95% CI = -018 to 6.89, p = .064), favoring the intervention group (MIG = 79.38 ± 9.44 vs. MCG = 75.45 ± 10.62). There were no group differences in diastolic blood pressure (-1.78 mm Hg; 95% CI = -4.50 to 0.95, p = .402) and heart rate (-0.684; 95% CI = -3.73 to 2.36, p = 0.683). The results of the present pilot study confirm the preliminary effectiveness of the digital lifestyle intervention, actensio, in reducing high blood pressure in patients with hypertension.
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PURPOSE: The cardiorespiratory polysomnography (PSG) is an expensive and limited resource. The Sleepiz One + is a novel radar-based contactless monitoring device that can be used e.g. for longitudinal detection of nocturnal respiratory events. The present study aimed to compare the performance of the Sleepiz One + device to the PSG regarding the accuracy of apnea-hypopnea index (AHI). METHODS: From January to December 2021, a total of 141 adult volunteers who were either suspected of having sleep apnea or who were healthy sleepers took part in a sleep study. This examination served to validate the Sleepiz One + device in the presence and absence of additional SpO2 information. The AHI determined by the Sleepiz One + monitor was estimated automatically and compared with the AHI derived from manual PSG scoring. RESULTS: The correlation between the Sleepiz-AHI and the PSG-AHI with and without additional SpO2 measurement was rp = 0.94 and rp = 0,87, respectively. In general, the Bland-Altman plots showed good agreement between the two methods of AHI measurement, though their deviations became larger with increasing sleep-disordered breathing. Sensitivity and specificity for recordings without additional SpO2 was 85% and 88%, respectively. Adding a SpO2 sensor increased the sensitivity to 88% and the specificity to 98%. CONCLUSION: The Sleepiz One + device is a valid diagnostic tool for patients with moderate to severe OSA. It can also be easily used in the home environment and is therefore beneficial for e.g. immobile and infectious patients. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION FOR PROSPECTIVELY REGISTERED TRIALS: This study was registered on clinicaltrials.gov (NCT04670848) on 2020-12-09.
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Background: Patients with advanced cancer do receive increasingly aggressive end-of-life care, despite it does often not prolong survival time but entails decreased quality of life for patients. This qualitative study explores the unfolding of aggressive end-of-life care in clinical practice focusing on the decision-making process and the quality of end-of-life care from family members' perspective. Materials and methods: We conducted semi-structured interviews with 16 family members (six of cancer patients with and ten without aggressive end-of-life care) at the National Center for Tumor Diseases Heidelberg, Germany. We conducted a content analysis applying a theoretical framework to differentiate between 'decision-making' (process of deciding for one choice among many options) and 'decision-taking' (acting upon this choice). Results: While patients of the aggressive care group tended to make and take decisions with their family members and physicians, patients of the other group took the decision against more aggressive treatment alone. Main reason for the decision in favor of aggressive care was the wish to spend more time with loved ones. Patients took decisions against aggressive care given the rapid decline in physical health and to spare relatives difficult decisions and arising feelings of guilt and self-reproach. Conclusion: Treatment decisions at end-of-life are always individual. Nevertheless, treatment courses with aggressive end-of-life care and those without differ markedly. To account for a longitudinal perspective on the interplay between patients, family members, and physicians, cohort studies are needed. Meanwhile, clinicians should validate patients and family members considering refraining from aggressive end-of-life care and explore their motives. Clinical trial registration: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022837, identifier DRKS00022837.
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OBJECTIVE: Despite available effective treatments for mental health disorders, few patients in need receive even the most basic care. Integrated telepsychiatry services may be a viable option to increase access to mental healthcare. The aim of this qualitative process evaluation embedded in a randomised controlled feasibility trial was to explore health providers' experiences with a mental healthcare model integrating mental health specialist video consultations (MHSVC) and primary care. METHODS: A qualitative process evaluation focusing on MHSVC in primary care was conducted. In 13 semistructured interviews, we assessed the experience of all mental health specialists, primary care physicians and medical assistants who participated in the trial. A thematic analysis, focusing on the implementation, mechanisms of impact and context, was applied to investigate the data. RESULTS: Considering (1) the implementation, participants evaluated the consultations as feasible, easy to use and time saving. Concerning (2) the mechanisms of impact, the consultations were regarded as effective for patients. Providers attributed the patients' improvements to two key aspects: the familiarity of the primary care practice and the fast access to specialist mental healthcare. Mental health specialists observed trustful therapeutic alliances emerging and described their experience as comparable to same-room care. However, compared with same-room care, specialists perceived the video consultations as more challenging and sometimes more exhausting due to the additional effort required for establishing therapeutic alliances. Regarding (3) the intervention's context, shorter travel distances for patients positively affected the implementation, while technical failures, that is, poor Internet connectivity, emerged as the main barrier. CONCLUSIONS: MHSVCs in primary care are feasible and successful in improving access to mental healthcare for patients. To optimise engagement and comfort of both patients and health providers, future work should focus on empirical determinants for establishing robust therapeutic alliances with patients receiving MHSVC (eg, leveraging non-verbal cues for therapeutic purposes). TRIAL REGISTRATION NUMBER: DRKS00015812; Results.
