scholarly journals Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial

BMJ ◽  
2021 ◽  
pp. n2209
Author(s):  
Michael H McGillion ◽  
Joel Parlow ◽  
Flavia K Borges ◽  
Maura Marcucci ◽  
Michael Jacka ◽  
...  
Keyword(s):  
Standard Care ◽  
Elective Surgery ◽  
Controlled Trial ◽  
Absolute Difference ◽  
Care Group ◽  
Standard Care Group ◽  
Virtual Care ◽  
Randomised Controlled ◽  
At Home

Abstract Objective To determine if virtual care with remote automated monitoring (RAM) technology versus standard care increases days alive at home among adults discharged after non-elective surgery during the covid-19 pandemic. Design Multicentre randomised controlled trial. Setting 8 acute care hospitals in Canada. Participants 905 adults (≥40 years) who resided in areas with mobile phone coverage and were to be discharged from hospital after non-elective surgery were randomised either to virtual care and RAM (n=451) or to standard care (n=454). 903 participants (99.8%) completed the 31 day follow-up. Intervention Participants in the experimental group received a tablet computer and RAM technology that measured blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, and body weight. For 30 days the participants took daily biophysical measurements and photographs of their wound and interacted with nurses virtually. Participants in the standard care group received post-hospital discharge management according to the centre’s usual care. Patients, healthcare providers, and data collectors were aware of patients’ group allocations. Outcome adjudicators were blinded to group allocation. Main outcome measures The primary outcome was days alive at home during 31 days of follow-up. The 12 secondary outcomes included acute hospital care, detection and correction of drug errors, and pain at 7, 15, and 30 days after randomisation. Results All 905 participants (mean age 63.1 years) were analysed in the groups to which they were randomised. Days alive at home during 31 days of follow-up were 29.7 in the virtual care group and 29.5 in the standard care group: relative risk 1.01 (95% confidence interval 0.99 to 1.02); absolute difference 0.2% (95% confidence interval −0.5% to 0.9%). 99 participants (22.0%) in the virtual care group and 124 (27.3%) in the standard care group required acute hospital care: relative risk 0.80 (0.64 to 1.01); absolute difference 5.3% (−0.3% to 10.9%). More participants in the virtual care group than standard care group had a drug error detected (134 (29.7%) v 25 (5.5%); absolute difference 24.2%, 19.5% to 28.9%) and a drug error corrected (absolute difference 24.4%, 19.9% to 28.9%). Fewer participants in the virtual care group than standard care group reported pain at 7, 15, and 30 days after randomisation: absolute differences 13.9% (7.4% to 20.4%), 11.9% (5.1% to 18.7%), and 9.6% (2.9% to 16.3%), respectively. Beneficial effects proved substantially larger in centres with a higher rate of care escalation. Conclusion Virtual care with RAM shows promise in improving outcomes important to patients and to optimal health system function. Trial registration ClinicalTrials.gov NCT04344665 .

scholarly journals One-year intensive lifestyle intervention and improvements in health-related quality of life and mental health in persons with type 2 diabetes: a secondary analysis of the U-TURN randomized controlled trial

2021 ◽  
Vol 9 (1) ◽  
pp. e001840
Author(s):  
Christopher Scott MacDonald ◽  
Sabrina M Nielsen ◽  
Jakob Bjørner ◽  
Mette Y Johansen ◽  
Robin Christensen ◽  
...  
Keyword(s):  
Lifestyle Intervention ◽  
Standard Care ◽  
Controlled Trial ◽  
Care Group ◽  
Standard Care Group ◽  
Intensive Lifestyle Intervention ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

IntroductionThe effects of lifestyle interventions in persons with type 2 diabetes (T2D) on health-related quality of life (HRQoL) and subjective well-being are ambiguous, and no studies have explored the effect of exercise interventions that meet or exceed current recommended exercise levels. We investigated whether a 1-year intensive lifestyle intervention is superior in improving HRQoL compared with standard care in T2D persons.Research design and methodsWe performed secondary analyses of a previously conducted randomized controlled trial (April 2015 to August 2016). Persons with non-insulin-dependent T2D (duration ≤10 years) were randomized to 1-year supervised exercise and individualized dietary counseling (ie, ‘U-TURN’), or standard care. The primary HRQoL outcome was change in the 36-item Short Form Health Survey (SF-36) physical component score (PCS) from baseline to 12 months of follow-up, and a key secondary outcome was changes in the SF-36 mental component score (MCS).ResultsWe included 98 participants (U-TURN group=64, standard care group=34) with a mean age of 54.6 years (SD 8.9). Between-group analyses at 12-month follow-up showed SF-36 PCS change of 0.8 (95% CI −0.7 to 2.3) in the U-TURN group and deterioration of 2.4 (95% CI −4.6 to −0.1) in the standard care group (difference of 3.2, 95% CI 0.5 to 5.9, p=0.02) while no changes were detected in SF-36 MCS. At 12 months, 19 participants (30%) in the U-TURN group and 6 participants (18%) in the standard care group achieved clinically significant improvement in SF-36 PCS score (adjusted risk ratio 2.6, 95% CI 1.0 to 4.5 corresponding to number needed to treat of 4, 95% CI 1.6 to infinite).ConclusionIn persons with T2D diagnosed for less than 10 years, intensive lifestyle intervention improved the physical component of HRQoL, but not the mental component of HRQoL after 1 year, compared with standard care.Trial registration numberNCT02417012.

The Nature stroke study; NASTRU - A randomised controlled trial of nature-based post-stroke fatigue rehabilitation

2019 ◽  
Author(s):  
Anna María Pálsdóttir ◽  
Kjerstin Stigmar ◽  
Bo Norrving ◽  
Patrik Grahn ◽  
Ingemar F Petersson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Perceived Value ◽  
Control Group ◽  
Post Stroke ◽  
Randomised Controlled

Abstract Fatigue is common after stroke and contributes to disability and impaired quality of life. Currently, there is insufficient evidence on the efficacy of any intervention for post-stroke fatigue. The aim of the study was to examine whether 10 weeks Nature-based rehabilitation (NRB) as add-on to standard care may improve post-stroke fatigue, perceived value of everyday occupations, function, activity and participation compared to standard care only (Clinical Trial.gov Identifier: NCT02435043, 2012/352, 05-06-2015). The study was carried out as a single blinded two-armed randomised controlled trial. Stroke survivors identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke > 1 year earlier) were randomised to Standard care + NBR or Standard care only. Blinded evaluations were conducted at follow-up 8 and 14 months after randomisation. The primary outcomes were post-stroke fatigue (Mental Fatigue Scale, total score) and perceived value of everyday occupations (Oval-pd) 8 months after randomisation. About a quarter of the screened patients were eligible; half accepted to participate and 101 were randomised, mean age 67 years, 60% female. The patients with sub-acute stroke were highly compliant with the intervention. Fatigue decreased to a value below the suggested cut-off for mental fatigue (<10.5) in the intervention group but not in the control group; no statistically significant differences were found though between the groups. Conclusion: NASTRU is the first randomised study on NBR for patients with post stroke fatigue. NBR was feasible and well tolerated. The study was underpowered due to difficulties in recruiting participants. No significant differences were detected between intervention and control group. A larger RCT is warranted. Keywords: clinical trial, enriched environment, everyday occupations, horticulture therapy, quality of life.

scholarly journals Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Meg Wiggins ◽  
Mary Sawtell ◽  
Octavia Wiseman ◽  
Christine McCourt ◽  
Sandra Eldridge ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Antenatal Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Trial Registration ◽  
Secondary Outcome ◽  
The World ◽  
Randomised Controlled

Abstract Background Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. Methods The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a ‘healthy baby’ composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born “healthy” in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional ‘healthy and positive birth’ of the intervention with standard care. Qualitative data will be analysed thematically. Discussion This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. Trial registration Trial registration; ISRCTN, ISRCTN91977441. Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.

scholarly journals Effectiveness of An Impedance Cardiography Guided Treatment Strategy to Improve Blood Pressure Control in A Real-World Setting: Results from A Pilot Pragmatic Clinical Trial

2021 ◽  
Author(s):  
Luyan Wang ◽  
Yuan Lu ◽  
Hongyi Wang ◽  
Jianlei Gu ◽  
Zheng J. Ma ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Real World ◽  
Treatment Strategy ◽  
Standard Care ◽  
Impedance Cardiography ◽  
Care Group ◽  
Standard Care Group ◽  
Peking University ◽  
The Mean

ABSTRACTBackgroundHypertension is a hemodynamic-related disorder characterized by abnormalities of the cardiac output (CO) and/or systemic vascular resistance (SVR). We hypothesized that selecting antihypertensive therapy based on patients’ hemodynamic profile could improve blood pressure (BP) control more effectively than standard care in hypertensive patients in real-world clinical practice.MethodsWe conducted a pilot single-center, pragmatic randomized trial involving adults with uncontrolled hypertension who sought outpatient care at a hypertension clinic of the Peking University People’s Hospital, the largest teaching hospital of Peking University, in Beijing China, between December 2018 and December 2019. Participants were randomly assigned to the standard care group or the hemodynamic group in a 1:1 ratio. Impedance cardiography (ICG) was performed with all participants to measure hemodynamic parameters. Only physicians in the hemodynamic group were provided with patients’ ICG findings and a computerized clinical decision support of recommended treatment choices based on patients’ hemodynamic profiles. The primary outcomes were the changes in systolic BP (SBP) and diastolic BP (DBP) levels at the follow-up visit 4-12 weeks after baseline. Secondary outcomes included achievement of BP goal of <140/ 90 mmHg and the changes in BP by baseline BP, age, sex, and BMI.ResultsA total 102 adults (mean age was 54±14 years; 41% were women) completed the study. The mean baseline SBP was 150.9 (±11.5) mmHg and mean baseline DBP was 91.1 (±11.3) mmHg. At the follow-up visit, the mean SBP and DBP decreased by 19.9 and 11.3 mmHg in the hemodynamic group, as compared with 12.0 and 4.9 mmHg in the standard care group (P value for difference between groups <0.001 for both SBP and DBP). The proportion of patients achieving BP goal of <140/ 90 mmHg in the hemodynamic group was 67%, as compared with 41% in the standard care group (P=0.017). The hemodynamic group had a larger effect on BP reduction consistently across subgroups by age, sex, BMI, and baseline BP.ConclusionsAn ICG-guided treatment strategy led to greater reductions in BP levels than were observed with standard care in a real-world population of outpatients with hypertension. There is a need for further validation of this strategy for improving blood pressure treatment selection. (Funded by internal research grant from the Peking University People’s Hospital; ClinicalTrials.gov number: NCT04715698.)

scholarly journals Effect of CPAP on cardiovascular events in minimally symptomatic OSA: long-term follow-up of the MOSAIC randomised controlled trial

2020 ◽  
Vol 7 (1) ◽  
pp. e000742
Author(s):  
Ivan Tang ◽  
Chris D Turnbull ◽  
Dushendree Sen ◽  
Sonya Craig ◽  
Malcolm Kohler ◽  
...  
Keyword(s):  
Obstructive Sleep Apnoea ◽  
Cardiovascular Events ◽  
Standard Care ◽  
Controlled Trial ◽  
Sleep Apnoea ◽  
Obstructive Sleep ◽  
Long Term Follow Up ◽  
Randomised Controlled

The effect of continuous positive airway pressure (CPAP) on cardiovascular events is uncertain in minimally symptomatic obstructive sleep apnoea. Previous 2-year follow-up data from the Multicentre Obstructive Sleep Apnoea Intervention Cardiovascular (MOSAIC) trial showed a marginal reduction in cardiovascular events with CPAP therapy. We now present long-term MOSAIC study follow-up data. Median (first quartile, third quartile) follow-up was 5.0 (2.2, 5.0) and 3.7 (1.5, 5.0) years for CPAP and standard care, respectively. Compared to standard care, CPAP had no statistically significant effect on the risk of cardiovascular events (HR=0.83, p=0.54, 95% CI 0.46–1.51).

scholarly journals Randomised controlled trial comparing hospital at home care with inpatient hospital care. I: three month follow up of health outcomes

BMJ ◽  
1998 ◽  
Vol 316 (7147) ◽  
pp. 1786-1791 ◽  
Author(s):  
S. Shepperd ◽  
D. Harwood ◽  
C. Jenkinson ◽  
A. Gray ◽  
M. Vessey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Home Care ◽  
Health Outcomes ◽  
Hospital Care ◽  
Controlled Trial ◽  
Inpatient Hospital ◽  
Hospital At Home ◽  
Randomised Controlled ◽  
At Home

scholarly journals Free healthy breakfasts in primary schools: a cluster randomised controlled trial of a policy intervention in Wales, UK

2010 ◽  
Vol 14 (2) ◽  
pp. 219-226 ◽  
Author(s):  
Simon Murphy ◽  
GF Moore ◽  
K Tapper ◽  
R Lynch ◽  
R Clarke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Schools ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Breakfast Skipping ◽  
Cluster Randomised ◽  
Positive Attitudes ◽  
Randomised Controlled ◽  
At Home

AbstractObjectiveThe present study evaluated the impact of a national school programme of universal free healthy breakfast provision in Wales, UK.DesignA cluster randomised controlled trial with repeated cross-sectional design and a 12-month follow-up. Primary outcomes were breakfast skipping, breakfast diet and episodic memory. Secondary outcomes were frequency of eating breakfast at home and at school, breakfast attitudes, rest-of-day diet and class behaviour.SettingPrimary schools in nine local education authority areas.SubjectsA total of 4350 students (aged 9–11 years) at baseline and 4472 at follow-up in 111 schools.ResultsStudents in intervention schools reported significantly higher numbers of healthy food items consumed at breakfast and more positive attitudes towards breakfast eating at 12 months. Parents in intervention schools reported significantly higher rates of consumption of breakfast at school and correspondingly lower rates of breakfast consumption at home. No other significant differences were found.ConclusionsThe intervention did not reduce breakfast skipping; rather, pupils substituted breakfast at home for breakfast at school. However, there were improvements in children’s nutritional intake at breakfast time, if not the rest of the day, and more positive attitudes to breakfast, which may have implications for life-course dietary behaviours. There was no impact on episodic memory or classroom behaviour, which may require targeting breakfast skippers.

scholarly journals Impact of mobile phone delivered reminders and unconditional incentives on measles-containing vaccine timeliness and coverage: a randomised controlled trial in western Kenya

2021 ◽  
Vol 6 (1) ◽  
pp. e003357
Author(s):  
E Wangeci Kagucia ◽  
Benard Ochieng ◽  
Joyce Were ◽  
Kyla Hayford ◽  
David Obor ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Monetary Incentive ◽  
Risk Difference ◽  
Absolute Difference ◽  
Adjusted Relative Risk ◽  
Adjusted Risk ◽  
Sms Reminders ◽  
Randomised Controlled

IntroductionShort message service (SMS) reminders coupled with a small monetary incentive conditioned on prompt vaccination have been shown to improve first-dose measles-containing vaccine (MCV1) uptake. We assessed whether SMS reminders and unconditional monetary incentives—more amenable to programmatic implementation—can improve MCV1 uptake in Kenya.MethodsCaregivers of eligible infants aged 6–8 months were enrolled into an individually randomised controlled trial and assigned to receive either: no intervention (control), two SMS reminders (SMS) sent 3 days, and 1 day before the scheduled MCV1 date, or SMS reminders coupled with a Kenya Shilling (KES) 150 incentive (SMS +150 KES) sent 3 days before the scheduled MCV1 date. Study staff conducted a household follow-up visit at age 12 months to ascertain vaccination status. Log-binomial regression was used to estimate the relative and absolute difference in MCV1 timely coverage (by age 10 months), the primary outcome.ResultsBetween 6 December 2016 and 31 March 2017, 179 infants were enrolled into each of the three study arms. Follow-up visits were completed between 19 April 2017 and 8 October 2017 for control (n=170), SMS (n=157) and SMS + 150 KES (n=158) children. MCV1 timely coverage was 68% among control arm infants compared with 78% in each intervention arm. This represented a non-statistically significant increase in the SMS arm (adjusted relative risk 1.13; 95% CI 0.99 to 1.30; p=0.070; adjusted risk difference 9.2%; 95% CI: −0.6 to 19.0%; p=0.066), but a statistically significant increase in the SMS + 150 KES arm (1.16; 95% CI 1.01 to 1.32; p=0.035; 10.6%; 95% CI 0.8 to 20.3%; p=0.034).ConclusionThese findings suggest that the effect of SMS reminders coupled with a small unconditional monetary incentive on MCV1 uptake is comparable to that of SMS reminders alone, limiting their utility. Further studies in the absence of unexpected supply-side constraints are needed.Trial registration numberNCT02904642

scholarly journals Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: randomised controlled trial

BMJ ◽  
2021 ◽  
pp. n84 ◽  
Author(s):  
Viviane C Veiga ◽  
João A G G Prats ◽  
Danielle L C Farias ◽  
Regis G Rosa ◽  
Leticia K Dourado ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Confidence Interval ◽  
Clinical Outcomes ◽  
Odds Ratio ◽  
Standard Care ◽  
Controlled Trial ◽  
Data Monitoring Committee ◽  
Ordinal Scale ◽  
Care Group ◽  
Standard Care Group

Abstract Objective To determine whether tocilizumab improves clinical outcomes for patients with severe or critical coronavirus disease 2019 (covid-19). Design Randomised, open label trial. Setting Nine hospitals in Brazil, 8 May to 17 July 2020. Participants Adults with confirmed covid-19 who were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two serum biomarkers (C reactive protein, D dimer, lactate dehydrogenase, or ferritin). The data monitoring committee recommended stopping the trial early, after 129 patients had been enrolled, because of an increased number of deaths at 15 days in the tocilizumab group. Interventions Tocilizumab (single intravenous infusion of 8 mg/kg) plus standard care (n=65) versus standard care alone (n=64). Main outcome measure The primary outcome, clinical status measured at 15 days using a seven level ordinal scale, was analysed as a composite of death or mechanical ventilation because the assumption of odds proportionality was not met. Results A total of 129 patients were enrolled (mean age 57 (SD 14) years; 68% men) and all completed follow-up. All patients in the tocilizumab group and two in the standard care group received tocilizumab. 18 of 65 (28%) patients in the tocilizumab group and 13 of 64 (20%) in the standard care group were receiving mechanical ventilation or died at day 15 (odds ratio 1.54, 95% confidence interval 0.66 to 3.66; P=0.32). Death at 15 days occurred in 11 (17%) patients in the tocilizumab group compared with 2 (3%) in the standard care group (odds ratio 6.42, 95% confidence interval 1.59 to 43.2). Adverse events were reported in 29 of 67 (43%) patients who received tocilizumab and 21 of 62 (34%) who did not receive tocilizumab. Conclusions In patients with severe or critical covid-19, tocilizumab plus standard care was not superior to standard care alone in improving clinical outcomes at 15 days, and it might increase mortality. Trial registration ClinicalTrials.gov NCT04403685 .

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