scholarly journals Enterosgel for the treatment of adults with acute diarrhoea in a primary care setting: a randomised controlled trial

2019 ◽  
Vol 6 (1) ◽  
pp. e000287 ◽  
Author(s):  
Carol Angela Howell ◽  
Elena Markaryan ◽  
Victoria Allgar ◽  
Anu Kemppinen ◽  
Aleksander Khovanov ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Acute Diarrhoea ◽  
Control Group ◽  
Number Needed To Treat ◽  
Symptom Duration ◽  
High Morbidity ◽  
Patient Reported ◽  
Randomised Controlled

BackgroundAcute intestinal infections are common conditions causing high morbidity and mortality especially in the young and elderly, resulting in a significant burden on health service resources and the economy. Current National Institute for Health and Care Excellence guidance are fluid and nutritional management; however, this does not reduce the duration of diarrhoea and the challenge of treating diarrhoea itself remains. We investigated the efficacy, tolerability and safety of intestinal adsorbent Enterosgel (polymethylsiloxane polyhydrate) compared with standard care in adults with acute diarrhoea.MethodsThis was a randomised controlled trial enrolling 105 subjects to receive the medical device Enterosgel up to six times daily for up to 8 days with standard care (oral rehydration solution), or standard care alone. The primary endpoint was the duration of diarrhoea (hours) from randomisation to first non-loose stool in the Enterosgel versus control group.ResultsA total of 51 subjects were randomised into the Enterosgel group and 54 into the control group, after excluding missing data, the data from 43 subjects in each group were analysed. Duration of diarrhoea was significantly shorter in the Enterosgel group at 27 hours versus 39 hours in the control group (HR was 1.74 [95% CI 1.06 to 2.87]) (p=0.03). This yielded a number needed to treat value of 5. Enterosgel was well tolerated and safe with no serious adverse events. One serious diarrhoea-related event resulting in hospitalisation was reported in the control group.ConclusionsEnterosgel treatment was associated with a significant reduction in the duration of diarrhoea in adults with patient-reported acute diarrhoea, compared with standard care. These findings support the role of Enterosgel in acute diarrhoea especially in vulnerable groups where rapid resolution of symptoms is required. Reduction in symptom duration could translate to less healthcare costs and socioeconomic burden.Trial registration numberISRCTN20758708

Effectiveness of a novel, automated telephone intervention on time to hospitalisation in patients with COPD: A randomised controlled trial

2018 ◽  
Vol 26 (3) ◽  
pp. 132-139
Author(s):  
Eric Sink ◽  
Kunjan Patel ◽  
Jacob Groenendyk ◽  
Robert Peters ◽  
Avik Som ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Primary Care Clinic ◽  
Automated System ◽  
Control Group ◽  
Number Needed To Treat ◽  
Care Clinic ◽  
Patient Reported ◽  
Randomised Controlled

Introduction Owing to its capacity to perform remote assessments, telemedicine is rising as a new force in chronic obstructive pulmonary disease (COPD) management. We conducted an eight month randomised-controlled-trial to study the effect of an automated telemedicine intervention on patients’ time-to-hospitalisation. Methods A total of 168 patients with a diagnosis of COPD in the past 24 months were enrolled to receive the intervention at a primary care clinic. The treatment group received daily phone messages from an automated system asking them to report if they were breathing better than, worse than, or the same as the day prior. Patients reported their breathing status by responding to the text message or call. If a patient reported breathing worse, an alert was sent directly to that patient’s provider within the clinic. The control group received the same daily phone messages as the treatment group. However, no proactive breathing alerts were ever generated to the provider for these subjects. The primary outcome was the subjects’ time-to-first-COPD-related hospitalisation following the start of messages. Results The treatment group’s time-to-hospitalisation was significantly different than the control group’s with a hazard ratio of 2.36 (95% confidence interval 1.02–5.45, p = 0.0443). The number needed-to-treat ratio was 8.62. Subject engagement consistently ranged between 60% and 75%. The treatment group received both proactive monitoring and follow-up care from the providers. Discussion Active monitoring with provider feedback enables the detection of exacerbation events early enough for subjects to avoid admissions. The use of non-smartphone interventions reduces barriers to care presented by more complicated and expensive technologies. This intervention represents a simple, innovative, and inexpensive tool for improved COPD management.

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 Effectiveness of online tailored advice to prevent running-related injuries and promote preventive behaviour in Dutch trail runners: a pragmatic randomised controlled trial

2017 ◽  
Vol 52 (13) ◽  
pp. 851-858 ◽  
Author(s):  
Luiz Carlos Hespanhol ◽  
Willem van Mechelen ◽  
Evert Verhagen
Keyword(s):  
Randomised Controlled Trial ◽  
Preventive Intervention ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Number Needed To Treat ◽  
Preventive Behaviour ◽  
Randomised Controlled ◽  
Tailored Advice

BackgroundTrail running is popular worldwide, but there is no preventive intervention for running-related injury (RRI).AimTo evaluate the effectiveness of adding online tailored advice (TrailS6) to general advice on (1) the prevention of RRIs and (2) the determinants and actual preventive behaviour in Dutch trail runners.MethodsTwo-arm randomised controlled trial over 6 months. 232 trail runners were randomly assigned to an intervention or control group. All participants received online general advice on RRI prevention 1 week after baseline. Every 2 weeks, participants in the intervention group received specific advice tailored to their RRI status. The control group received no further intervention. Bayesian mixed models were used to analyse the data.ResultsTrail runners in the intervention group sustained 13% fewer RRIs compared with those in the control group after 6 months of follow-up (absolute risk difference −13.1%, 95% Bayesian highest posterior credible interval (95% BCI) −23.3 to −3.1). A preventive benefit was observed in one out of eight trail runners who had received the online tailored advice for 6 months (number needed to treat 8, 95% BCI 3 to 22). No significant between-group difference was observed on the determinants and actual preventive behaviours.ConclusionsOnline tailored advice prevented RRIs among Dutch trail runners. Therefore, online tailored advice may be used as a preventive component in multicomponent RRI prevention programmes. No effect was observed on determinants and actual preventive behaviours.Trial registration numberThe Netherlands National Trial Register (NTR5431).

London–East Anglia randomised controlled trial of cognitive–behavioural therapy for psychosis

1997 ◽  
Vol 171 (4) ◽  
pp. 319-327 ◽  
Author(s):  
Elizabeth Kuipers ◽  
Philippa Garety ◽  
David Fowler ◽  
Graham Dunn ◽  
Paul Bebbington ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Standard Care ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Psychotic Symptoms ◽  
Control Group ◽  
Improve Outcome ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundA series of small, mainly uncontrolled, studies have suggested that techniques adapted from cognitive–behavioural therapy (CBT) for depression can improve outcome in psychosis, but no large randomised controlled trial of intensive treatment for medication-resistant symptoms of psychosis has previously been published.MethodSixty participants who each had at least one positive and distressing symptom of psychosis that was medication-resistant were randomly allocated between a CBT and standard care condition (n=28) and a standard care only control condition (n=32). Therapy was individualised, and lasted for nine months. Multiple assessments of outcome were used.ResultsOver nine months, improvement was significant only in the treatment group, who showed a 25% reduction on the BPRS. No other clinical, symptomatic or functioning measure changed significantly. Participants had a low drop-out rate from therapy (11%), and expressed high levels of satisfaction with treatment (80%). Fifty per cent of the CBT group were treatment responders (one person became worse), compared with 31% of the control group (three people became worse and another committed suicide)ConclusionsCBT for psychosis can improve overall symptomatology. The findings provide evidence that even a refractory group of clients with a long history of psychosis can engage in talking about psychotic symptoms and their meaning, and this can improve outcome.

scholarly journals Effects of therapeutic play on children undergoing cast-removal procedures: a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021071 ◽  
Author(s):  
Cho Lee Wong ◽  
Wan Yim Ip ◽  
Blondi Ming Chau Kwok ◽  
Kai Chow Choi ◽  
Bobby King Wah Ng ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Age Groups ◽  
Intervention Group ◽  
Control Group ◽  
Play Intervention ◽  
Score Difference ◽  
Randomised Controlled ◽  
Therapeutic Play

ObjectivesTo examine (1) the effectiveness of therapeutic play in reducing anxiety and negative emotional manifestations among children undergoing cast-removal procedures and (2) the satisfaction of parents and cast technicians with cast-removal procedures.DesignA randomised controlled trial.SettingAn orthopaedic outpatient department of a regional teaching hospital in Hong Kong.ParticipantsChildren (n=208) aged 3–12 undergoing cast-removal procedure were invited to participate.InterventionsEligible children were randomly allocated to either the intervention (n=103) or control group (n=105) and stratified by the two age groups (3–7 and 8–12 years). The intervention group received therapeutic play intervention, whereas the control group received standard care only. Participants were assessed on three occasions: before, during and after completion of the cast-removal procedure.Outcome measuresChildren’s anxiety level, emotional manifestation and heart rate. The satisfaction ratings of parents and cast technicians with respect to therapeutic play intervention were also examined.ResultsFindings suggested that therapeutic play assists children aged 3–7 to reduce anxiety levels with mean differences between the intervention and control group was −20.1 (95% CI −35.3 to −4.9; p=0.01). Overall, children (aged 3–7 and 8–12) in the intervention groups exhibited fewer negative emotional manifestations than the control group with a mean score difference −2.2 (95% CI −3.1 to −1.4; p<0.001). Parents and technicians in the intervention group also reported a higher level of satisfaction with the procedures than the control group with a mean score difference of 4.0 (95% CI −5.6 to 2.3; p<0.001) and 2.6 (95% CI 3.7 to 1.6; p<0.001), respectively.ConclusionTherapeutic play effectively reduces anxiety and negative emotional manifestations among children undergoing cast-removal procedures. The findings highlight the importance of integrating therapeutic play into standard care, in particular for children in younger age.Trial registration numberChiCTR-IOR-15006822; Pre-results.

scholarly journals Decreasing Hypothermia-Related Escalation of Care in Newborn Infants Using the BEMPU TempWatch: A Randomised Controlled Trial

Children ◽  
2021 ◽  
Vol 8 (11) ◽  
pp. 1068
Author(s):  
Donna Lei ◽  
Kenneth Tan ◽  
Atul Malhotra
Keyword(s):  
Randomised Controlled Trial ◽  
Exclusive Breastfeeding ◽  
Standard Care ◽  
Controlled Trial ◽  
Newborn Infants ◽  
Tertiary Hospital ◽  
Control Group ◽  
Initial Hospital ◽  
Randomised Controlled ◽  
To Receive

Objective: To determine whether incorporating BEMPU TempWatch into the care of LBW/SGA neonates for continuous temperature monitoring decreases the rate of hypothermia requiring escalation of care. Methods: This was a randomised controlled trial conducted in a tertiary hospital in Melbourne, Australia. Participants were late preterm and term LBW/SGA neonates on the postnatal wards. Neonates were randomly assigned to receive either the BEMPU TempWatch in addition to standard care, or to receive standard care alone for the first 28 days of life. The primary outcome was hypothermia requiring escalation of care during initial hospital stay after birth. Results: Trial was discontinued after planned interim feasibility analysis, due to very low rates of hypothermia requiring escalation of care. In total, 75 neonates were included, with 36 in the intervention (TempWatch) group and 39 in the control group. The rate of hypothermia requiring escalation of care was 2/36 (5.6%) in the TempWatch group and 1/39 (2.6%) in the control group (relative risk (RR) 2.17, 95% CI 0.21 to 22.89). Rates of exclusive breastfeeding at discharge were 22/36 (61.1%) in the TempWatch and 13/39 (33.3%) in the control group (RR 1.83, 95% CI 1.10 to 3.07, p = 0.02). All other secondary outcomes were similar between the groups. Conclusions: Low rates of hypothermia requiring escalation of care in a tertiary, high-income setting meant it was not feasible for studying the effects of the TempWatch for this outcome. TempWatch may have a role in promoting exclusive breastfeeding, and this needs to be explored further.

scholarly journals Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE)

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e037515
Author(s):  
Matilda Cederberg ◽  
Lilas Ali ◽  
Inger Ekman ◽  
Kristina Glise ◽  
Ingibjörg H Jonsdottir ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Mental Disorders ◽  
Sick Leave ◽  
Self Efficacy ◽  
Standard Care ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Control Group ◽  
Positive Effects ◽  
Randomised Controlled

IntroductionThe number of people dealing with common mental disorders (CMDs) is a major concern in many countries, including Sweden. Sickness absence resulting from CMDs is often long-lasting and advancing return to work is a complex process impacted by several factors, among which self-efficacy appears to be an important personal resource. Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context.Methods and analysisThis study is an open randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform. The primary outcome measure is a composite score of changes in sick leave and self-efficacy. Participants will include 220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date. Inclusion is ongoing and expected to be completed during the fall of 2020. A process and health economic evaluation will also be conducted.Ethics and disseminationThis study was approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. This project is part of a broader research programme conducted at the Gothenburg Centre for Person-Centred Care (GPCC), where extensive work is undertaken to disseminate knowledge on and implementation of PCC.Trial registration numberNCT03404583.

scholarly journals An enhanced care package to improve asthma management in Malawian children: a randomised controlled trial

Thorax ◽  
2021 ◽  
pp. thoraxjnl-2020-216065 ◽  
Author(s):  
Sarah Rylance ◽  
Beatrice Chinoko ◽  
Bright Mnesa ◽  
Chris Jewell ◽  
Jonathan Grigg ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Low Income ◽  
Standard Care ◽  
Controlled Trial ◽  
Scale Up ◽  
Asthma Management ◽  
Control Group ◽  
Asthma Care ◽  
Care Package ◽  
Randomised Controlled

BackgroundShortages of clinical staff make chronic asthma care challenging in low-income countries. We evaluated an outpatient asthma care package for children, including task-shifting of asthma management roles.MethodsWe conducted a non-blinded individually randomised controlled trial at a tertiary-level government hospital in Blantyre, Malawi. Children aged 6–15 years diagnosed with asthma were recruited from outpatient clinic, stratified by Childhood Asthma Control Test (cACT) score and allocated 1:1 from a concealed file, accessed during electronic questionnaire completion. The intervention, delivered by non-physicians, comprised clinical assessment, optimisation of inhaled treatment, individualised asthma education. The control group received standard care from outpatient physicians. Primary outcome for intention-to-treat analysis was change in cACT score at 3 months. Secondary outcomes included asthma exacerbations requiring emergency healthcare and school absence.FindingsBetween September 2018 and December 2019, 120 children (59 intervention; 61 control) were recruited; 65.8% males, with mean (SD) age 9.8 (2.8) years, mean (SD) baseline cACT 20.3 (2.6). At 3 months, intervention children (n=56) had a greater mean (SD) change in cACT score from baseline (2.7 (2.8) vs 0.6 (2.8)) compared with standard care participants (n=59); a difference of 2.1 points (95% CI: 1.1 to 3.1, p<0.001). Fewer intervention children attended emergency healthcare (7.3% vs 25.4%, p=0.02) and missed school (20.0% vs 62.7%, p<0.001) compared with standard care children.InterpretationThe intervention resulted in decreased asthma symptoms and exacerbations. Wider scale-up could present substantial benefits for asthmatic patients in resource-limited settings.Trial registration numberPACTR201807211617031.

scholarly journals Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

2021 ◽  
Author(s):  
Ruth E. Ashton ◽  
Jonathan J. Aning ◽  
Garry A. Tew ◽  
Wendy A Robson ◽  
John M Saxton
Keyword(s):  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Muscular Strength ◽  
Controlled Trial ◽  
Control Group ◽  
Robot Assisted ◽  
Resistance Exercise Training ◽  
Home Based ◽  
Aerobic Exercise Capacity ◽  
Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

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