#Telemedicine

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Supporting the Primary Outcomes of the Mirai Trial for the Adjunctive Digital Therapeutic Rejoyn (CT-152) in the Treatment of Major Depressive Disorder: Meaningful Change Analysis in the Montgomery-Åsberg Depression Rating Scale

Background: Rejoyn (CT-152) is a prescription digital therapeutic (DTx) adjunct to antidepressive medication authorized for patients with major depressive disorder. To better understand the patient benefit of DTx and other treatment modalities, current regulatory standards support the use of modern psychometric methods to interpret the clinical meaningfulness of treatment effects for patients. In the primary analysis of Rejoyn from the pivotal phase 3 Mirai trial (NCT04770285), Rejoyn showed a broad risk-to-benefit profile as demonstrated on multiple clinician- and patient-rated scales, including the primary efficacy outcome measure, the Montgomery-Åsberg Depression Rating Scale (MADRS). These findings supported US Food and Drug Administration authorization of Rejoyn as a prescription DTx. However, the clinical relevance of these changes in the MADRS score is not immediately interpretable in clinical practice. Here, we present the results from several post hoc analyses of the Mirai trial data to support the interpretation of clinically meaningful treatment differences on clinician- and patient-reported change in depressive symptoms. Objective: This study had two main objectives: (1) establish threshold parameters that allow for clinically meaningful interpretation of the Mirai results in clinical practice, based on the clinical trial end points of change from baseline in depressive symptoms, and (2) apply this threshold in a responder and sensitivity analysis in the intent-to-treat (ITT) population (which is more frequently reported in pharmacological trials) to further support the interpretation of change in unblinded analysis of the Mirai results. Methods: For the Mirai meaningful within-patient change (MWPC) analysis, anchor-based methods were used to define an MWPC threshold by exploring the associations between the MADRS and the clinician-rated Clinical Global Impression-Severity Scale (CGI-S) and the patient-reported Patient Health Questionnaire 9-Item Scale (PHQ-9). Additional post hoc efficacy analyses (including that of responders) are reported for the ITT population. Results: Using the MWPC thresholds of 8 and 10 points (derived with the CGI-S and PHQ-9 as anchor measures, respectively), the distribution of MADRS responders favored the Rejoyn group over the sham group, and the Rejoyn group had 24%‐47% higher odds of meaningful improvement on the MADRS. Post hoc ITT analyses also favored the Rejoyn group over the sham group for response rates and PHQ-9 and CGI-S score change from baseline. Conclusions: Results are consistent with the primary findings of the Mirai trial, supporting the efficacy of Rejoyn as an adjunctive treatment to antidepressive medication monotherapy for adults with major depressive disorder. The MWPC analyses offered a measure of meaningful change on the MADRS, providing a framework of clinical meaningfulness for the Mirai trial findings.

www.nexthorizon.space

AI Telemedicine: Remote Patient Monitoring, Virtual Wards and Hospital-at-Home Care

AI telemedicine is moving care into the home through remote monitoring, virtual wards, wearables and hospital-at-home programs. Here is what works.

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Training primary care staff in delivering the primary care consultation remotely: a systematic review

Background Remote consultation is widely used in primary care, and its use has increased greatly since the onset of the COVID-19 pandemic. Despite this, primary care clinicians lack formal training in...

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A theory-based analysis of the implementation of online asynchronous telemedicine platforms into primary care practices using Normalisation Process Theory

Background Online asynchronous telemedicine platforms are effective and have been implemented in primary care practices, but it is unclear whether implementation was successful. Implementation has not...

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Hybrid Telemedicine–House-Call Model for Pneumonia Management in North Texas: Retrospective Pilot Study

Background: Pneumonia accounts for approximately 1.4 million emergency department (ED) visits annually in the United States. Hybrid care models integrating telemedicine with in-home clinical support may offer a novel approach to managing appropriately selected patients while optimizing ED use. Objective: This study aimed to evaluate a hybrid house-call model for managing adults with pneumonia by describing patient characteristics, use patterns, illness severity, and ED referral rates. Methods: We conducted a retrospective descriptive case-series study among adults diagnosed with pneumonia within a primary and urgent care system between January 1, 2022, and January 1, 2024. Cases were identified using the International Classification of Diseases, 10th Revision (ICD-10) codes (J18.9, J15.8, J16.8, J17, and J18.1). In total, 30 patient records were screened, and 28 met the eligibility criteria for analysis. The hybrid model combined virtual physician evaluation with in-home assessment by a trained health care professional using digital diagnostic tools. Data collected included visit type, treatments, comorbidities, CRB-65 (confusion, respiratory rate, blood pressure, age ≥65 years) scores, and ED referrals. Differences between patients referred to the ED and those who were not referred to the ED were evaluated using the Mann-Whitney U test. Results: In total, 28 patients accounted for 56 clinical encounters (median 2, IQR 1-3 encounters per patient). CRB-65 scores ranged from 0 to 2, with 13 (46.4%) patients scoring 0, 13 (46.4%) patients scoring 1, and 2 (7.1%) patients scoring 2. Of the 28 patients, 8 (28.6%) were referred to the ED. Patients referred to the ED had significantly higher CRB-65 scores than those managed without ED referral (median 1, IQR 1-1.5 vs median 0, IQR 0-1; Mann-Whitney U=34.0; P=.01). Conclusions: This retrospective descriptive case-series study demonstrates the implementation of a hybrid telemedicine–house-call model for adults with pneumonia in a real-world clinical setting. Larger prospective comparative studies with longitudinal follow-up are needed to evaluate clinical outcomes, referral performance, safety, and effectiveness.

www.dailyalpine.com

Telemedicine will expand Graz violence clinic

A telemedicine project will expand access to the violence clinic at the Medical University of Graz, where victims are professionally examined and evidence is secured for possible court proceedings, ORF Steiermark reported. The forensic medicine service is based only in Graz and also covers Carint…

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