Background In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov ( NCT04381936 ). Findings Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12–1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77–0·92; p<0·0001). Interpretation In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids. Funding UK Research and Innovation (Medical Research Council) and National Institute of Health Research.
BackgroundWeb-based interventions that provide personalized physical activity advice have demonstrated good effectiveness but rely on self-reported measures of physical activity, which are prone to overreporting, potentially reducing the accuracy and effectiveness of the advice provided.ObjectiveThis study aimed to examine whether the effectiveness of a Web-based computer-tailored intervention could be improved by integrating Fitbit activity trackers.MethodsParticipants received the 3-month TaylorActive intervention, which included 8 modules of theory-based, personally tailored physical activity advice and action planning. Participants were randomized to receive the same intervention either with or without Fitbit tracker integration. All intervention materials were delivered on the Web, and there was no face-to-face contact at any time point. Changes in physical activity (Active Australia Survey), sitting time (Workforce Sitting Questionnaire), and body mass index (BMI) were assessed 1 and 3 months post baseline. Advice acceptability, website usability, and module completion were also assessed.ResultsA total of 243 Australian adults participated. Linear mixed model analyses showed a significant increase in total weekly physical activity (adjusted mean increase=163.2; 95% CI 52.0-274.5; P=.004) and moderate-to-vigorous physical activity (adjusted mean increase=78.6; 95% CI 24.4-131.9; P=.004) in the Fitbit group compared with the non-Fitbit group at the 3-month follow-up. The sitting time and BMI decreased more in the Fitbit group, but no significant group × time interaction effects were found. The physical activity advice acceptability and the website usability were consistently rated higher by participants in the Fitbit group. Non-Fitbit group participants completed 2.9 (SD 2.5) modules, and Fitbit group participants completed 4.4 (SD 3.1) modules.ConclusionsIntegrating physical activity trackers into a Web-based computer-tailored intervention significantly increased intervention effectiveness.Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12616001555448; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371793 (Archived by WebCite at http://www.webcitation.org/73ioTxQX2)
(1) Background: Interventions using activity trackers and smartphone apps have demonstrated their ability to increase physical activity in children and adults. However, they have not been tested in whole families. Further, few family-centered interventions have actively involved both parents and assessed physical activity effects separately for children, mothers and fathers. Objective: To examine the feasibility and short-term effects of an activity tracker and app intervention to increase physical activity in the whole family (children, mothers and fathers). (2) Methods: This was a single-arm feasibility study with pre-post intervention measures. Between 2017–2018, 40 families (58 children aged 6–10 years, 39 mothers, 33 fathers) participated in the 6-week Step it Up Family program in Queensland, Australia. Using commercial activity trackers combined with apps (Garmin Vivofit Jr for children, Vivofit 3 for adults; Garmin Australasia Pty Ltd., Sydney, Australia), the intervention included individual and family-level goal-setting, self-monitoring, performance feedback, family step challenges, family social support and modelling, weekly motivational text messages and an introductory session. Parent surveys were used to assess physical activity effects measured as pre-post intervention changes in moderate-to-vigorous physical activity (MVPA) in children, mothers and fathers. Objective Garmin activity tracker data was recorded to assess physical activity levels (steps, active minutes) during the intervention. (3) Results: Thirty-eight families completed the post intervention survey (95% retention). At post intervention, MVPA had increased in children by 58 min/day (boys: 54 min/day, girls: 62 min/day; all p < 0.001). In mothers, MVPA increased by 27 min/day (p < 0.001) and in fathers, it increased by 31 min/day (p < 0.001). The percentage of children meeting Australia’s physical activity guidelines for children (≥60 MVPA min/day) increased from 34% to 89% (p < 0.001). The percentage of mothers and fathers meeting Australia’s physical activity guidelines for adults (≥150 MVPA min/week) increased from 8% to 57% (p < 0.001) in mothers and from 21% to 68% (p < 0.001) in fathers. The percentage of families with ‘at least one child and both parents’ meeting the physical activity guidelines increased from 0% to 41% (p < 0.001). Objective activity tracker data recorded during the intervention showed that the mean (SD) number of active minutes per day in children was 82.1 (17.1). Further, the mean (SD) steps per day was 9590.7 (2425.3) in children, 7397.5 (1954.2) in mothers and 8161.7 (3370.3) in fathers. (4) Conclusions: Acknowledging the uncontrolled study design, the large pre-post changes in MVPA and rather high step counts recorded during the intervention suggest that an activity tracker and app intervention can increase physical activity in whole families. The Step it Up Family program warrants further efficacy testing in a larger, randomized controlled trial.
ObjectivesSome online, personally tailored, text-based physical activity interventions have proven effective. However, people tend to ‘skim’ and ‘scan’ web-based text rather than thoroughly read their contents. In contrast, online videos are more engaging and popular. We examined whether web-based personally tailored physical activity videos were more effective in promoting physical activity than personally tailored text and generic information.Methods501 adults were randomised into a video-tailored intervention, text-tailored intervention or control. Over a 3-month period, intervention groups received access to eight sessions of web-based personally tailored physical activity advice. Only the delivery method differed between intervention groups: tailored video versus tailored text. The primary outcome was 7-day ActiGraph-GT3X+ measured moderate-to-vigorous physical activity (MVPA) assessed at 0, 3 and 9 months. Secondary outcomes included self-reported MVPA and website engagement. Differences were examined using generalised linear mixed models with intention-to-treat and multiple imputation.ResultsAccelerometer-assessed MVPA increased 23% in the control (1.23 (1.06, 1.43)), 12% in the text-tailored (1.12 (0.95, 1.32)) and 28% in the video-tailored (1.28 (1.06, 1.53)) groups at the 3-month follow-up only, though there were no significant between-group differences. Both text-tailored (1.77 (1.37, 2.28]) and video-tailored (1.37 (1.04, 1.79)) groups significantly increased self-reported MVPA more than the control group at 3 months only, but there were no differences between video-tailored and text-tailored groups. The video-tailored group spent significantly more time on the website compared with text-tailored participants (90 vs 77 min, p=0.02).ConclusionsThe personally tailored videos were not more effective than personally tailored text in increasing MVPA. The findings from this study conflict with pilot study outcomes and previous literature. Process evaluation and mediation analyses will provide further insights.Trial registration numberACTRN12615000057583
IntroductionPhysical activity is an integral part of healthy ageing, yet the majority of older adults 65+ years are not sufficiently active. Web-based physical activity interventions hold much promise to reach older adults. Preliminary evidence suggests that web-based interventions with tailored advice and Fitbits may be well suited for older adults.Methods and analysisThis study aims to test the effectiveness of ‘Active for Life’, a 12-week computer-tailored web-based physical activity intervention using Fitbits for older adults. We will recruit 300 participants who will be randomly assigned to one of three trial arms: (1) web-based physical activity intervention with tailored advice only, (2) web-based physical activity intervention with tailored advice and Fitbit or (3) a wait-list control. The primary outcome, objective moderate to vigorous physical activity (MVPA) and secondary outcomes of objective sedentary behaviour, objective sleep, quality of life, social support, physical function and satisfaction with life will be assessed at baseline and week 12. The secondary outcomes of self-reported physical activity, sitting time and sleep will be assessed at baseline, week 6, 12 and 24. Website usability and participant satisfaction will be assessed at week 12 and website usage and intervention fidelity will be assessed from week 1 to 24. Intention-to-treat linear mixed model analyses will be used to test for group (tailoring only, tailoring +Fitbit, control) differences on changes in the main outcome, MVPA and secondary outcomes. Generalised linear models will be used to compare intervention groups (tailoring only, tailoring +Fitbit) on website usability, participant satisfaction, website usage and intervention fidelity.Ethics and disseminationThe study has received ethics approval from the Central Queensland University Human Research Ethics Committee (H16/12-321). Study outcomes will be disseminated through peer-reviewed publications and academic conferences and used to inform improvements and dissemination of a tailored, web-based physical activity intervention for adults 65+ years.Trial registration numberAustralian and New Zealand Clinical Trials Registry Number: ACTRN12618000646246
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