Safety and efficacy of pulmonary physiotherapy in hospitalized patients with severe COVID-19 pneumonia (PPTCOVID study): A prospective, randomised, single-blind, controlled trial.

BACKGROUND: Pulmonary physiotherapy (PPT) is an important treatment in the management of patients with different types of pulmonary disorders. We aimed to evaluate safety and efficacy of PPT in hospitalized patients with severe COVID-19 pneumonia. METHODS: In this randomised, single-blind, controlled trial, we enrolled hospitalized, non-intubated patients (18 to 75 years with oxygen saturation (Spo2) in free-air breathing ≤90%) with COVID-19 pneumonia at a referral hospital. Participants were randomly assigned (1:1) to receive PPT (six sessions PPT with breathing exercises and airway clearance techniques) or basic care. The primary outcomes were venous blood O2 (pO2) and CO2 (pCO2) pressures, Spo2, and three-minute walking test (3MWT) that were assessed before and end of sixth session. Secondary outcomes included level of dyspnea, venous blood PH, one-month mortality, three-month mortality and short form-36 (SF-36) after one and three months. The assessor was blinded to the assignment. This trial is registered with ClinicalTrials.gov (NCT04357340). FINDINGS: In April-May 2020, 40 participants were randomly assigned to PPT or basic care groups. While at the end of intervention, pO2 (adjusted mean difference to baseline measure (AMD) 6.43 mmHg [95%CI 2.8, 10.07], P<0.01), Spo2 (AMD 4.43% [95%CI 2.04, 6.83], P = 0.0011), and 3MTW (AMD 91.44 m [95%CI 68.88, 113.99], P<0.01) were higher in PPT group and basic care group, pCO2 was not improved (AMD -2.1 mmHg [95%CI-6.36, 2.21], P = 0.33). Based on the logistic model adjusted to baseline Spo2, the risks of mortality were reduced 81% ([95%CI: 97% reduction to 30% increase], P = .09) and 84% ([95%CI 74% reduction to 5% increase], P = .06) at one-month and three-month, respectively. There were no significant differences in most SF-36 domains scores after one and three months. No serious adverse event was observed during PPT sessions. CONCLUSION: Early PPT can be considered a safe and relatively effective therapeutic choice for patients with severe COVID-19.

The effect of COVID rehabilitation for ongoing symptoms Post HOSPitalisation with COVID-19 (PHOSP-R): protocol for a randomised parallel group controlled trial on behalf of the PHOSP consortium.

INTRODUCTION: Many adults hospitalised with COVID-19 have persistent symptoms such as fatigue, breathlessness and brain fog that limit day-to-day activities. These symptoms can last over 2 years. Whilst there is limited controlled studies on interventions that can support those with ongoing symptoms, there has been some promise in rehabilitation interventions in improving function and symptoms either using face-to-face or digital methods, but evidence remains limited and these studies often lack a control group. METHODS AND ANALYSIS: This is a nested single-blind, parallel group, randomised control trial with embedded qualitative evaluation comparing rehabilitation (face-to-face or digital) to usual care and conducted within the PHOSP-COVID study. The aim of this study is to determine the effectiveness of rehabilitation interventions on exercise capacity, quality of life and symptoms such as breathlessness and fatigue. The primary outcome is the Incremental Shuttle Walking Test following the eight week intervention phase. Secondary outcomes include measures of function, strength and subjective assessment of symptoms. Blood inflammatory markers and muscle biopsies are an exploratory outcome. The interventions last eight weeks and combine symptom-titrated exercise therapy, symptom management and education delivered either in a face-to-face setting or through a digital platform ( www.yourcovidrecovery.nhs.uk ). The proposed sample size is 159 participants, and data will be intention-to-treat analyses comparing rehabilitation (face-to-face or digital) to usual care. ETHICS AND DISSEMINATION: Ethical approval was gained as part of the PHOSP-COVID study by Yorkshire and the Humber Leeds West Research NHS Ethics Committee, and the study was prospectively registered on the ISRCTN trial registry (ISRCTN13293865). Results will be disseminated to stakeholders, including patients and members of the public, and published in appropriate journals. Strengths and limitations of this study • This protocol utilises two interventions to support those with ongoing symptoms of COVID-19 • This is a two-centre parallel-group randomised controlled trial • The protocol has been supported by patient and public involvement groups who identified treatments of symptoms and activity limitation as a top priority.

Videoconferencing-delivered psychological intervention for the treatment of COVID-19 related psychological distress in University students: study protocol for a randomised controlled trial in India.

BACKGROUND: The mental health impacts of the COVID-19 pandemic have been profound. This paper outlines the study protocol for a trial that tests the efficacy of a brief group-based psychological intervention (Coping with COVID; CWC), relative to Supportive Counselling, to reduce distress associated with COVID-19 in a young adult population in Bangalore, India. METHODS: A single-blind, parallel, randomized controlled trial will be carried out via video conferencing in a small group format. Following informed consent, adults that screen positive for levels of psychological distress (Kessler 10 (K-10 score ≥ 20) and have access to a videoconferencing platform will be randomised to an adapted version of CWC (n = 90) or Supportive Counselling (SC) (n = 90). The primary outcome will be reduction in psychological distress including anxiety and depression at 2-months post treatment. Secondary outcomes include worry, positive wellbeing, and stress in relation to COVID-19. DISCUSSION: This treatment trial will assess whether CWC will result in reduced distress relative to Supportive Counselling in a young adult population in Bangalore, India. This study will yield important insights into the role of nonspecific factors versus the intervention's components in impacting COVID-19 related distress. TRIAL REGISTRATION: This trial was prospectively registered on the Australian New Zealand Clinical Trials Registry (ACTRN12621001064897). ETHICS AND DISSEMINATION: Ethics approval has been obtained from the participating institution, CHRIST University in Bangalore. Results of the trial will be submitted for publication in peer reviewed journals and findings presented at scientific conferences and to key service providers and policy makers.

VV116 versus Nirmatrelvir-Ritonavir for Oral Treatment of Covid-19.

BACKGROUND: Nirmatrelvir-ritonavir has been authorized for emergency use by many countries for the treatment of coronavirus disease 2019 (Covid-19). However, the supply falls short of the global demand, which creates a need for more options. VV116 is an oral antiviral agent with potent activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). METHODS: We conducted a phase 3, noninferiority, observer-blinded, randomized trial during the outbreak caused by the B.1.1.529 (omicron) variant of SARS-CoV-2. Symptomatic adults with mild-to-moderate Covid-19 with a high risk of progression were assigned to receive a 5-day course of either VV116 or nirmatrelvir-ritonavir. The primary end point was the time to sustained clinical recovery through day 28. Sustained clinical recovery was defined as the alleviation of all Covid-19-related target symptoms to a total score of 0 or 1 for the sum of each symptom (on a scale from 0 to 3, with higher scores indicating greater severity; total scores on the 11-item scale range from 0 to 33) for 2 consecutive days. A lower boundary of the two-sided 95% confidence interval for the hazard ratio of more than 0.8 was considered to indicate noninferiority (with a hazard ratio of >1 indicating a shorter time to sustained clinical recovery with VV116 than with nirmatrelvir-ritonavir). RESULTS: A total of 822 participants underwent randomization, and 771 received VV116 (384 participants) or nirmatrelvir-ritonavir (387 participants). The noninferiority of VV116 to nirmatrelvir-ritonavir with respect to the time to sustained clinical recovery was established in the primary analysis (hazard ratio, 1.17; 95% confidence interval [CI], 1.01 to 1.35) and was maintained in the final analysis (median, 4 days with VV116 and 5 days with nirmatrelvir-ritonavir; hazard ratio, 1.17; 95% CI, 1.02 to 1.36). In the final analysis, the time to sustained symptom resolution (score of 0 for each of the 11 Covid-19-related target symptoms for 2 consecutive days) and to a first negative SARS-CoV-2 test did not differ substantially between the two groups. No participants in either group had died or had had progression to severe Covid-19 by day 28. The incidence of adverse events was lower in the VV116 group than in the nirmatrelvir-ritonavir group (67.4% vs. 77.3%). CONCLUSIONS: Among adults with mild-to-moderate Covid-19 who were at risk for progression, VV116 was noninferior to nirmatrelvir-ritonavir with respect to the time to sustained clinical recovery, with fewer safety concerns. (Funded by Vigonvita Life Sciences and others; ClinicalTrials.gov number, NCT05341609; Chinese Clinical Trial Registry number, ChiCTR2200057856.).

A Community Health Worker-Based Intervention on Anthropometric Outcomes of Children Aged 3 to 21 Months in Urban Pakistan, 2019-2021.

Objectives. To evaluate the impact of a community health worker-based "in-home growth monitoring with counseling" (IHGMC) intervention on anthropometric outcomes in Pakistan, where 38% of children younger than 5 years are stunted. Methods. We used an individual, single-blind, step-wedge randomized controlled trial and a pure control group recruited at endline. We based the analysis on an intention-to-treat estimation using the coarsened exact matching (CEM) method for sample selection among treatments and the control. We conducted the baseline in July 2019 and completed endline in September-October 2021. We recruited 1639 households (treated: 1188; control: 451) with children aged 3 to 21 months who were residing in an urban informal settlement area. The CEM sample used for analysis numbered 1046 (treated: 636; control: 410). The intervention continued for 6 months. Results. Compared with the control group, the height-for-age z-score in the IHGMC group increased by 0.58 SD (95% confidence interval [CI] = 0.33, 0.83; P = .001) and the weight-for-age z-score by 0.43 SD (95% CI = 0.20, 0.67; P < .01), measured at endline. Conclusions. IHGMC substantially improved child anthropometric outcomes in disadvantaged localities, and this impact persisted during the COVID-19 pandemic. Trial Registration. AER-RCT registry (AEARCTR-0003248). (Am J Public Health. 2023;113(1):105-114. https://doi.org/10.2105/AJPH.2022.307111).

Mental Health Chatbot for Young Adults With Depressive Symptoms During the COVID-19 Pandemic: Single-Blind, Three-Arm Randomized Controlled Trial.

BACKGROUND: Depression has a high prevalence among young adults, especially during the COVID-19 pandemic. However, mental health services remain scarce and underutilized worldwide. Mental health chatbots are a novel digital technology to provide fully automated interventions for depressive symptoms. OBJECTIVE: The purpose of this study was to test the clinical effectiveness and nonclinical performance of a cognitive behavioral therapy (CBT)-based mental health chatbot (XiaoE) for young adults with depressive symptoms during the COVID-19 pandemic. METHODS: In a single-blind, 3-arm randomized controlled trial, participants manifesting depressive symptoms recruited from a Chinese university were randomly assigned to a mental health chatbot (XiaoE; n=49), an e-book (n=49), or a general chatbot (Xiaoai; n=50) group in a ratio of 1:1:1. Participants received a 1-week intervention. The primary outcome was the reduction of depressive symptoms according to the 9-item Patient Health Questionnaire (PHQ-9) at 1 week later (T1) and 1 month later (T2). Both intention-to-treat and per-protocol analyses were conducted under analysis of covariance models adjusting for baseline data. Controlled multiple imputation and δ-based sensitivity analysis were performed for missing data. The secondary outcomes were the level of working alliance measured using the Working Alliance Questionnaire (WAQ), usability measured using the Usability Metric for User Experience-LITE (UMUX-LITE), and acceptability measured using the Acceptability Scale (AS). RESULTS: Participants were on average 18.78 years old, and 37.2% (55/148) were female. The mean baseline PHQ-9 score was 10.02 (SD 3.18; range 2-19). Intention-to-treat analysis revealed lower PHQ-9 scores among participants in the XiaoE group compared with participants in the e-book group and Xiaoai group at both T1 (F2,136=17.011; P<.001; d=0.51) and T2 (F2,136=5.477; P=.005; d=0.31). Better working alliance (WAQ; F2,145=3.407; P=.04) and acceptability (AS; F2,145=4.322; P=.02) were discovered with XiaoE, while no significant difference among arms was found for usability (UMUX-LITE; F2,145=0.968; P=.38). CONCLUSIONS: A CBT-based chatbot is a feasible and engaging digital therapeutic approach that allows easy accessibility and self-guided mental health assistance for young adults with depressive symptoms. A systematic evaluation of nonclinical metrics for a mental health chatbot has been established in this study. In the future, focus on both clinical outcomes and nonclinical metrics is necessary to explore the mechanism by which mental health chatbots work on patients. Further evidence is required to confirm the long-term effectiveness of the mental health chatbot via trails replicated with a longer dose, as well as exploration of its stronger efficacy in comparison with other active controls. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100052532; http://www.chictr.org.cn/showproj.aspx?proj=135744.

Institution and gender-related differences in publication speed before and during COVID-19.

The COVID-19 pandemic elicited a substantial hike in journal submissions and a global push to get medical evidence quickly through the review process. Editorial decisions and peer-assessments were made under intensified time constraints, which may have amplified social disparities in the outcomes of peer-reviewing, especially for COVID-19 related research. This study quantifies the differential impact of the pandemic on the duration of the peer-review process for women and men and for scientists at different strata of the institutional-prestige hierarchy. Using mixed-effects regression models with observations clustered at the journal level, we analysed newly available data on the submission and acceptance dates of 78,085 medical research articles published in 2019 and 2020. We found that institution-related disparities in the average time from manuscript submission to acceptance increased marginally in 2020, although half of the observed change was driven by speedy reviews of COVID-19 research. For COVID-19 papers, we found more substantial institution-related disparities in review times in favour of authors from highly-ranked institutions. Descriptive survival plots also indicated that scientists with prestigious affiliations benefitted more from fast-track peer reviewing than did colleagues from less reputed institutions. This difference was more pronounced for journals with a single-blind review procedure compared to journals with a double-blind review procedure. Gender-related changes in the duration of the peer-review process were small and inconsistent, although we observed a minor difference in the average review time of COVID-19 papers first authored by women and men.

Mental Health Chatbot for Young Adults With Depressive Symptoms During the COVID-19 Pandemic: Single-Blind, Three-Arm Randomized Controlled Trial.

BACKGROUND: Depression has a high prevalence among young adults, especially during the COVID-19 pandemic. However, mental health services remain scarce and underutilized worldwide. Mental health chatbots are a novel digital technology to provide fully automated interventions for depressive symptoms. OBJECTIVE: The purpose of this study was to test the clinical effectiveness and nonclinical performance of a cognitive behavioral therapy (CBT)-based mental health chatbot (XiaoE) for young adults with depressive symptoms during the COVID-19 pandemic. METHODS: In a single-blind, 3-arm randomized controlled trial, participants manifesting depressive symptoms recruited from a Chinese university were randomly assigned to a mental health chatbot (XiaoE; n=49), an e-book (n=49), or a general chatbot (Xiaoai; n=50) group in a ratio of 1:1:1. Participants received a 1-week intervention. The primary outcome was the reduction of depressive symptoms according to the 9-item Patient Health Questionnaire (PHQ-9) at 1 week later (T1) and 1 month later (T2). Both intention-to-treat and per-protocol analyses were conducted under analysis of covariance models adjusting for baseline data. Controlled multiple imputation and δ-based sensitivity analysis were performed for missing data. The secondary outcomes were the level of working alliance measured using the Working Alliance Questionnaire (WAQ), usability measured using the Usability Metric for User Experience-LITE (UMUX-LITE), and acceptability measured using the Acceptability Scale (AS). RESULTS: Participants were on average 18.78 years old, and 37.2% (55/148) were female. The mean baseline PHQ-9 score was 10.02 (SD 3.18; range 2-19). Intention-to-treat analysis revealed lower PHQ-9 scores among participants in the XiaoE group compared with participants in the e-book group and Xiaoai group at both T1 (F2,136=17.011; P<.001; d=0.51) and T2 (F2,136=5.477; P=.005; d=0.31). Better working alliance (WAQ; F2,145=3.407; P=.04) and acceptability (AS; F2,145=4.322; P=.02) were discovered with XiaoE, while no significant difference among arms was found for usability (UMUX-LITE; F2,145=0.968; P=.38). CONCLUSIONS: A CBT-based chatbot is a feasible and engaging digital therapeutic approach that allows easy accessibility and self-guided mental health assistance for young adults with depressive symptoms. A systematic evaluation of nonclinical metrics for a mental health chatbot has been established in this study. In the future, focus on both clinical outcomes and nonclinical metrics is necessary to explore the mechanism by which mental health chatbots work on patients. Further evidence is required to confirm the long-term effectiveness of the mental health chatbot via trails replicated with a longer dose, as well as exploration of its stronger efficacy in comparison with other active controls. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100052532; http://www.chictr.org.cn/showproj.aspx?proj=135744.

Caring Texts, a strength-based, suicide prevention trial in 5 native communities: Research design and methods.

BACKGROUND: Despite their intrinsic strengths and resilience, some American Indian and Alaska Native (AI/AN) communities experience among the highest rates of suicide of any racial and ethnic group. Caring Contacts is one of the only interventions shown to reduce suicide in clinical trials, but it has not been tested in AI/AN settings. OBJECTIVE: To compare the effectiveness of Enhanced Usual Care (control) to Enhanced Usual Care augmented with a culturally adapted version of Caring Contacts (intervention) for reducing suicidal ideation, suicide attempts, and suicide-related hospitalizations. METHODS: We are implementing a single blind randomized controlled trial of Caring Contacts in five AI/AN communities across the country (South Dakota, Montana, Oklahoma, and Alaska). Eligible participants have to be (1) actively suicidal or have made a suicide attempt within the past year; (2) at least 18 years of age; (3) AI/AN; (4) able to speak and read English; (5) able to participate voluntarily; (6) willing to be contacted by text, email or postal mail; and (7) able to provide consent. Following consent and baseline assessment, participants are randomized to receive either Enhanced Usual Care alone, or Enhanced Usual Care with 12 months (25 messages) of culturally adapted Caring Contacts. Follow-up assessments are conducted at 12 and 18 months. CONCLUSIONS: If effective, this study of Caring Contacts will inform programs to reduce suicide in the study communities as well as inform future research on Caring Contacts in other tribal settings. Modifications to continue the trial during the COVID-19 pandemic are discussed. CLINICAL TRIALS REGISTRATION: NCT02825771.

Influence of Digital Intervention Messaging on Influenza Vaccination Rates Among Adults With Cardiovascular Disease in the United States: Decentralized Randomized Controlled Trial.

BACKGROUND: Seasonal influenza affects 5% to 15% of Americans annually, resulting in preventable deaths and substantial economic impact. Influenza infection is particularly dangerous for people with cardiovascular disease, who therefore represent a priority group for vaccination campaigns. OBJECTIVE: We aimed to assess the effects of digital intervention messaging on self-reported rates of seasonal influenza vaccination. METHODS: This was a randomized, controlled, single-blind, and decentralized trial conducted at individual locations throughout the United States over the 2020-2021 influenza season. Adults with self-reported cardiovascular disease who were members of the Achievement mobile platform were randomized to receive or not receive a series of 6 patient-centered digital intervention messages promoting influenza vaccination. The primary end point was the between-group difference in self-reported vaccination rates at 6 months after randomization. Secondary outcomes included the levels of engagement with the messages and the relationship between vaccination rates and engagement with the messages. Subgroup analyses examined variation in intervention effects by race. Controlling for randomization group, we examined the impact of other predictors of vaccination status, including cardiovascular condition type, vaccine drivers or barriers, and vaccine knowledge. RESULTS: Of the 49,138 randomized participants, responses on the primary end point were available for 11,237 (22.87%; 5575 in the intervention group and 5662 in the control group) participants. The vaccination rate was significantly higher in the intervention group (3418/5575, 61.31%) than the control group (3355/5662, 59.25%; relative risk 1.03, 95% CI 1.004-1.066; P=.03). Participants who were older, more educated, and White or Asian were more likely to report being vaccinated. The intervention was effective among White participants (P=.004) but not among people of color (P=.42). The vaccination rate was 13 percentage points higher among participants who completed all 6 intervention messages versus none, and at least 2 completed messages appeared to be needed for effectiveness. Participants who reported a diagnosis of COVID-19 were more likely to be vaccinated for influenza regardless of treatment assignment. CONCLUSIONS: This personalized, evidence-based digital intervention was effective in increasing vaccination rates in this population of high-risk people with cardiovascular disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT04584645; https://clinicaltrials.gov/ct2/show/NCT04584645.

Women's EmotionS, Trauma and EmpowErMent (W-ES.T.EEM) study protocol: a psychoeducational support intervention for victims of domestic violence - a randomised controlled trial.

INTRODUCTION: Intimate partner violence (IPV) is a widespread phenomenon that affects the physical and mental well-being of victims. Several barriers prevented sufferers from receiving face-to-face interventions. These obstacles increased with the advent of the COVID-19 pandemic, and online psychological intervention can represent a valid solution to increase the well-being of IPV victims. This manuscript describes the study protocol for a single blind randomised controlled trial that examines the efficacy of a web-based psychoeducational intervention for IPV victims that integrates dialectical behavioural therapy and the empowerment approach. METHODS AND ANALYSIS: Eighty-six women who were victims of IPV during the COVID-19 outbreak will be recruited by the Interdepartmental Center for Family Research (CIRF) staff from the several antiviolence centres located in Italy. Participants will be randomly allocated to the Women's EmotionS, Trauma and EmpowErMent experimental group or the treatment as usual control condition. Both interventions will be administered individually to each woman. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the University of Padua (protocol no 4300). Written informed consent will be obtained from all research participants before study entry. Study results will be published as peer-reviewed articles. Any relevant protocol changes will be reported in the published articles. The results will be reported anonymously. TRIAL REGISTRATION NUMBER: ISRCTN12880309.

The Effects of Theory-Based Educational Intervention and WhatsApp Follow-up on Papanicolaou Smear Uptake Among Postnatal Women in Malaysia: Randomized Controlled Trial.

BACKGROUND: Despite the availability and accessibility of free Papanicolaou (Pap) smear as a screening tool for cervical cancer, the uptake of Pap smear in Malaysia has not changed in the last 15 years. Previous studies have shown that the high uptake of Pap smear reduces the mortality rate of patients with cervical cancer. The low uptake of Pap smear is multifactorial, and the problem could be minimized through the use of mobile technologies. Nevertheless, most intervention studies focused on individual factors, while other important aspects such as mobile technologies, especially WhatsApp, have not been investigated yet. OBJECTIVE: This study aims to determine the effects of a theory-based educational intervention and WhatsApp follow-up (Pap smear uptake [PSU] intervention) in improving PSU among postnatal women in Seremban, Negeri Sembilan, Malaysia. METHODS: A 2-arm, parallel single-blind cluster randomized controlled trial was conducted among postpartum women from the Seremban district. Twelve health clinics were randomly assigned to the intervention and control groups. At baseline, both groups received a self-administered questionnaire. The intervention group received standard care and PSU intervention delivered by a researcher. This 2-stage intervention module was developed based on Social Cognitive Theory, where the first stage was conducted face-to-face and the second stage included a WhatsApp follow-up. The control group received standard care. Participants were observed immediately and at 4, 8, and 12 weeks after the intervention. The primary endpoint was PSU, whereas the secondary endpoints were knowledge, attitude, and self-efficacy scores for Pap smear screening self-assessed using a Google Forms questionnaire. A generalized mixed model was used to determine the effectiveness of the intervention. All data were analyzed using IBM SPSS (version 25), and P value of .05 was considered statistically significant. RESULTS: We analyzed 401 women, of whom 76 (response rate: 325/401, 81%) had withdrawn because of the COVID-19 pandemic, with a total of 162 respondents in the intervention group and 163 respondents in the control group. The proportion of Pap smears at the 12-week follow-up was 67.9% (110/162) in the intervention group versus 39.8% (65/163) in the control group (P<.001). Significant differences between the intervention and control groups were found for Pap smear use (F4,1178; P<.001), knowledge scores (F4,1172=14.946; P<.001), attitude scores (F4,1172=24.417; P<.001), and self-efficacy scores (F1,1172=10.432; P<.001). CONCLUSIONS: This study demonstrated that the PSU intervention is effective in increasing the uptake of Pap smear among postnatal women in Seremban district, Malaysia. This intervention module can be tested in other populations of women. TRIAL REGISTRATION: Thai Clinical Trials Registry TCTR20200205001; https://www.thaiclinicaltrials.org/show/TCTR20200205001.

Prehabilitation and heart failure: main outcomes in the COVID-19 era.

OBJECTIVE: The advent of the SARS-CoV-2 pandemic has resulted in an increase in sedentary behavior, with consequences on cardiopulmonary capacity, especially in the elderly population. Prehabilitation is a strategy usually used before a surgical procedure to improve functional capacity; however, it can be used for non-surgical patients and not in the acute phase of disease. The purpose of this study is to evaluate the effectiveness of a prehabilitation program, using telerehabilitation, in frail elderly patients with chronic heart failure. PATIENTS AND METHODS: This is a randomized, controlled, single-blind study. Fifteen patients with chronic heart failure were randomized into three groups: two active groups (telerehabilitation and in-person) and the control group. Patients in the active groups underwent a rehabilitation program divided into two 4-week periods, for 45-60 minutes per day, 2 days per week. RESULTS: In the Study Group, the quality of life significantly improved (EQoL-5D), and between the two groups a statistically significant difference in the motor dimension of SF-36 was identified. CONCLUSIONS: The telerehabilitation prehabilitation program for patients with chronic heart failure was confirmed to be effective and not inferior to a prehabilitation program performed in-person, avoiding the worsening of some domains of quality of life and motor performance, and leading to the improvement of others.

Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.

BACKGROUND: Most displaced people with mental disorders in low- and middle-income countries do not receive effective care, and their access to care has deteriorated during the Coronavirus Disease 2019 (COVID-19) pandemic. Digital mental health interventions are scalable when digital access is adequate, and they can be safely delivered during the COVID-19 pandemic. We examined whether a new WHO-guided digital mental health intervention, Step-by-Step, in which participants were supported by a nonspecialist helper, was effective in reducing depression among displaced people in Lebanon. METHODS AND FINDINGS: We conducted a single-blind, 2-arm pragmatic randomized clinical trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among displaced Syrians suffering from depression and impaired functioning in Lebanon. Primary outcomes were depression (Patient Health Questionnaire, PHQ-9) and impaired functioning (WHO Disability Assessment Schedule-12, WHODAS) at posttreatment. Secondary outcomes included subjective well-being, anxiety, post-traumatic stress, and self-described problems. A total of 569 displaced people from Syria with depression (PHQ-9 ≥ 10) and impaired functioning (WHODAS > 16) were randomized to Step-by-Step (N = 283; lost to follow-up: N = 167) or ECAU (N = 286; lost to follow-up: 133). Participants were considered to be lost to follow-up when they did not fill in the outcome measures at posttest or follow-up. Recruitment started on December 9, 2019 and was completed on July 9, 2020. The last follow-up assessments were collected in December 2020. The study team had access to the online platform, where they could see treatment arm assignment for each participant. All questionnaires were completed by participants online. Intention-to-treat (ITT) analyses showed intervention effects on depression (standardized mean differences [SMDs]: 0.48; 95% CI: 0.26; 0.70; p < 0.001), impaired functioning (SMD: 0.35; 95% CI: 0.14; 0.56; p < 0.001), post-traumatic stress (SMD: 0.36; 95% CI: 0.16; 0.56; p < 0.001), anxiety (SMD: 0.46; 95% CI: 0.24; 0.68; p < 0.001), subjective well-being (SMD: 0.47; 95% CI: 0.26; 0.68; p < 0.001), and self-identified personal problems (SMD: 0.49; 95% CI 0.28; 0.70; p < 0.001). Significant effects on all outcomes were maintained at 3 months follow-up. During the trial, one serious adverse event occurred, unrelated to the intervention. The main limitation of the current trial is the high dropout rate. CONCLUSIONS: In this study, we found that a guided, digital intervention was effective in reducing depression in displaced people in Lebanon. The guided WHO Step-by-Step intervention we examined should be made available to communities of displaced people that have digital access. TRIAL REGISTRATION: ClinicalTrials.gov NCT03720769.

Randomized clinical trial of integral cognitive remediation program for major depression (INCREM).

BACKGROUND: Despite achieving clinical remission, patients with depression encounter difficulties to return to their premorbid psychosocial functioning. Cognitive dysfunction has been proposed to be a primary mediator of functional impairment. Therefore, the new non-pharmacological procognitive strategy INtegral Cognitive REMediation for Depression (INCREM) has been developed with the aim of targeting cognitive and psychosocial functioning. METHODS: This is a single-blind randomized controlled clinical trial with three treatment arms. Fifty-two depressed patients in clinical remission, with psychosocial difficulties and cognitive impairment, were randomly assigned to receive INCREM intervention, Psychoeducation programme, or treatment as usual. Patients were assessed before and after the study period, and six months after. The primary outcome was the change from baseline of patients' psychosocial functioning. Changes in cognitive functioning and other variables were considered secondary outcomes. RESULTS: The analysis showed a significant improvement in psychosocial functioning in the INCREM group, especially six months after the intervention, compared to patients who received the psychoeducation programme. An improvement in cognitive performance was also observed in the INCREM group. LIMITATIONS: This study includes a small sample size due to the anticipated end of the clinical trial because of the COVID-19 pandemic. DISCUSSION: These results provide preliminary evidence on the feasibility and potential efficacy of the INCREM program to improve not only cognitive performance but also psychosocial functioning in clinically remitted depressed patients, and such improvement is maintained six months after. It can be speculated that the maintenance is mediated by the cognitive enhancement achieved with INCREM.

Comparison of telerehabilitation versus home-based video exercise in patients with Duchenne muscular dystrophy: a single-blind randomized study.

INTRODUCTION: Patients with Duchenne muscular dystrophy (DMD) have lost their access to on-site rehabilitation due to the COVID-19 pandemic. Telerehabilitation can be a viable approach for these patients to protect their muscle strength and functional status. The aim of this study is to compare telerehabilitation with home-based video exercises. PATIENTS AND METHODS: Male, ambulatory DMD patients were randomized into telerehabilitation and video-exercise groups. Nineteen patients were included in the final analyses. Telerehabilitation consisted of live online exercises, while video exercise implemented a pre-recorded video as a home-based program. Both programs spanned 8 weeks, three times a week. Patients' muscle strength with a hand-held dynamometer, Quick Motor Function Test, North-Star Ambulatory Assessment (NSAA), 6-Minute Walk Test (6MWT) and Caregiver Burden were recorded before and after treatment. RESULTS: The 6MWT of the telerehabilitation group was391.26 ± 95.08 m before and387.75 ± 210.93 after treatment (p = 0.94) and 327.46 ± 103.88 m before treatment and313.77 ± 114.55 after treatment in video group (p = 0.63). The mean NSAA score of the telerehabilitation group were26.70 ± 8.04 before treatment and 25.20 ± 11.33 after treatment (p = 0.24). In the video group scores were 21.66 ± 6.65 before to 22.00 ± 8.61 after treatment (p = 0.87). There were no significant changes between groups at the end of the treatments. The telerehabilitation group's neck extension, bilateral shoulder abduction, and left shoulder flexion, bilateral knee flexion and extension, bilateral ankle dorsiflexion, and left ankle plantar flexion strength improved significantly and were better than the video group (p < 0.05 for all measurements). CONCLUSION: A telerehabilitation approach is superior in improving muscle strength than a video-based home exercise, but none of the programs improved functional outcomes in ambulatory patients with DMD.

Effects of 3 months of multi-nutrient supplementation on the immune system and muscle and respiratory function of older adults in aged care (The Pomerium Study): protocol for a randomised controlled trial.

INTRODUCTION: Immunosenescence leads to increased morbidity and mortality associated with viral infections and weaker vaccine responses. This has been well documented for seasonal influenza and the current pandemic with SARS-CoV-2 (COVID-19), which disproportionately impact older adults, particularly those in residential aged care facilities. Inadequate nutrient intakes associated with impaired immunity, respiratory and muscle function are likely to augment the effects of immunosenescence. In this study, we test whether the impact of inadequate nutrition can be reversed using multi-nutrient supplementation, consequently enhancing vaccine responses, reducing the risk of viral infections and improving respiratory and muscle function. METHODS AND ANALYSIS: The Pomerium Study is a 3-month, single-blind, randomised, controlled trial testing the effects of two daily servings of an oral multi-nutrient supplement (330 kcal, 20 g protein, 1.5 g calcium 3-hydroxy-3-methylbutyrate monohydrate (CaHMB), 449 mg calcium, 500 IU vitamin D3 and 25 vitamins and minerals) on the immune system and muscle and respiratory function of older adults in aged care in Melbourne, Australia. 160 older adults (≥75 years old) will be recruited from aged care facilities and randomised to treatment (multi-nutrient supplement) or control (usual care). The primary outcome is a change in T-cell subsets CD8 + and CD28null counts at months 1 and 3. Secondary outcomes measured at baseline and month 3 are multiple markers of immunosenescence (also at 1 month), body composition (bioimpedance), handgrip strength (dynamometer), physical function (short physical performance battery), respiratory function (spirometry) and quality of life (EQ-5D-5L). Incidence and complications of COVID-19 and/or viral infections (ie, hospitalisation, complications or death) will be recorded throughout the trial, including 3 months after supplementation is ceased. ETHICS AND DISSEMINATION: This study was approved by Melbourne Health Human Research Ethics Committee (Ref No. HREC/73985/MH-2021, ERM Ref No. RMH73985, Melbourne Health Site Ref No. 2021.115). Written informed consent will be obtained from participants. Results will be published in peer-reviewed journals and made available to key aged care stakeholders, including providers, residents, and government bodies. TRIAL REGISTRATION NUMBER: ACTRN12621000420842.

IV Sodium Ferric Gluconate Complex in Patients With Iron Deficiency Hospitalized due to Acute Heart Failure-Investigator Initiated, Randomized Controlled Trial.

ABSTRACT: Patients with heart failure (HF) with iron deficiency (ID) have worse New York Heart Association class and are at a higher risk of recurrent hospitalizations. Intravenous (IV) iron has been shown to improve exercise ability and reduce hospitalizations. IV sodium ferric gluconate complex (SFGC) has been found to be safe and affordable but has not been studied in this population in a randomized trial. This was a prospective, single-blind, investigator-initiated, randomized controlled trial. Patients admitted for acute heart failure with ID were randomly assigned 1:1 to receive IV SFGC on top of optimal medical treatment. The primary outcome was the change in the 6-minute walk test (6MWT) from baseline to 3 and 6 months. Between September 2019 and May 2021, 34 patients were randomized. 19 patients (55%) were randomized to the treatment arm receiving 125 mg of IV SFGC per day for 3-5 days. COVID-19 was a major barrier to the implementation of the study follow-up protocol, which caused the study to end early. Both groups of patients had similar clinical characteristics, comorbidities, median left ventricular ejection fraction, and rate of death and readmissions due to HF. A higher level of NT-proBNP was observed in patients treated with IV iron (7902 pg/mL vs. 3158, P = 0.04). There was no difference in 6MWT change between groups at 3 months (improvement of 21.6 vs. 24.1 meters) or 6 months (-5 meters vs. 46 meters). In conclusion, IV SFGC-treated patients had a comparable 6-minute walk at 3 and 6 months despite suffering from more severe HF with higher baseline NT-proBNP (NCT04063033).