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

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.

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

10.21203/rs.2.461/v1 ◽

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.

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Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial

BMJ Open Gastroenterology ◽

10.1136/bmjgast-2020-000376 ◽

2020 ◽

Vol 7 (1) ◽

pp. e000376

Author(s):

Sivakami Janahiraman ◽

Chan Yen Tay ◽

Jie Min Lee ◽

Wen Ling Lim ◽

Chun Hoe Khiew ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Bowel Preparation ◽

Controlled Trial ◽

Tertiary Hospital ◽

Educational Programme ◽

Control Group ◽

Randomised Controlled ◽

The Impact ◽

Experimental Group

ObjectivePreprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.DesignAn accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).ResultsA total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).ConclusionAn intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.

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

The British Journal of Psychiatry ◽

10.1192/bjp.171.4.319 ◽

1997 ◽

Vol 171 (4) ◽

pp. 319-327 ◽

Cited By ~ 244

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.

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

BMJ Open Gastroenterology ◽

10.1136/bmjgast-2019-000287 ◽

2019 ◽

Vol 6 (1) ◽

pp. e000287 ◽

Cited By ~ 2

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

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Providing mothers with mobile phone message reminders increases childhood immunisation and vitamin A supplementation coverage in Côte d’Ivoire: a randomised controlled trial

Journal of Public Health in Africa ◽

10.4081/jphia.2019.1032 ◽

2019 ◽

Vol 10 (1) ◽

Author(s):

Romance Dissieka ◽

Marissa Soohoo ◽

Amynah Janmohamed ◽

David Doledec

Keyword(s):

Randomised Controlled Trial ◽

Vitamin A ◽

Mobile Phone ◽

Cote D'ivoire ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Vitamin A Supplementation ◽

Randomised Controlled ◽

To Receive

We conducted a randomised controlled trial to assess the effect of providing mothers with mobile voice or text (SMS) reminder messages on health facility attendance at five infant immunisation and vitamin A supplementation (VAS) visits. The study was conducted at 29 health facilities in Korhogo district. Mothers were randomised to receive a voice or text reminder message two days prior to each scheduled visit and two additional reminders for missed doses (n = 798; intervention group), or no phone reminder messages (n = 798; control group). Infants in the intervention group were 2.85 (95% CI: 1.85-4.37), 2.80 (95% CI: 1.88-4.17), 2.68 (95% CI: 1.84- 3.91), and 4.52 (95% CI: 2.84-7.20) times more likely to receive pentavalent 1-3 and MMR/yellow fever doses, respectively, and 5.67 (95% CI: 3.48-9.23) times more likely to receive VAS, as compared to the control group. In the reminder group, 58.3% of infants completed all five visits, compared to 35.7% in the control group (P < 0.001). Providing mothers mobile phone message reminders is a potentially effective strategy for improving immunisation and VAS coverage in Côte d’Ivoire.

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WeChat-based intervention to support breastfeeding for Chinese mothers: protocol of a randomised controlled trial

BMC Medical Informatics and Decision Making ◽

10.1186/s12911-020-01322-8 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Li Tang ◽

Andy H. Lee ◽

Colin W. Binns ◽

Lian Duan ◽

Yi Liu ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Exclusive Breastfeeding ◽

Intervention Program ◽

Controlled Trial ◽

Control Group ◽

Worst Case ◽

Breastfeeding Rate ◽

Maternity Hospitals ◽

Breastfeeding Rates ◽

Randomised Controlled

Abstract Background Exclusive breastfeeding for the first 6 months of life is the optimal way to feed infants. However, recent studies suggest that exclusive breastfeeding rates in China remain low and are well below the recommended target. There has been evidence that a lack of awareness of, or exposure to, breastfeeding information is associated with poor breastfeeding practices. WeChat, the most widely used social networking platform in China, has shown some potential to promote health behaviours. We thus hypothesised that a breastfeeding intervention program delivered via WeChat would achieve at least a 10% increase in exclusive breastfeeding prevalence at 6 months compared to the control group. Methods A two-arm, parallel, multicentre randomised controlled trial of 1000 pregnant women will be conducted at four maternity hospitals of Chengdu, China. Eligible women who consent to participate in the trial will be recruited at 28–30 weeks of gestation, and randomly allocated to either the intervention group (participants receive breastfeeding-related information from WeChat) or the control group (participants receive non-breastfeeding information from WeChat) using a central randomisation system on a 1:1 ratio at each participating site. The primary outcomes are exclusive breastfeeding rate and full breastfeeding rate at 6 months postpartum. All randomised participants will be included in the outcome analyses with missing data being imputed based on the best-case and worst-case scenarios. Multilevel mixed regression models will be used in the primary analyses to assess the effectiveness of intervention program on the breastfeeding rates. Discussion This trial uses the most widely used social media program as a means of delivering messages to mothers to increase exclusive breastfeeding in China. Increasing exclusive breastfeeding will contribute to meeting the health and environmental goals of the Sustainable Development Guidelines. Trial registration ClinicalTrials.gov, NCT04499404. Registered 5 August 2020—Retrospectively registered, https://clinicaltrials.gov/show/NCT04499404

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

BMJ Open ◽

10.1136/bmjopen-2017-021071 ◽

2018 ◽

Vol 8 (7) ◽

pp. e021071 ◽

Cited By ~ 5

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.

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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 ◽

10.1136/bmjopen-2020-037515 ◽

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.

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

Thorax ◽

10.1136/thoraxjnl-2020-216065 ◽

2021 ◽

pp. thoraxjnl-2020-216065 ◽

Cited By ~ 1

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.

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Improving Breastfeeding by Empowering Mothers in Vietnam: A Randomised Controlled Trial of a Mobile App

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17155552 ◽

2020 ◽

Vol 17 (15) ◽

pp. 5552 ◽

Cited By ~ 1

Author(s):

Thi Thuy Duong Doan ◽

Colin Binns ◽

Ngoc Minh Pham ◽

Yun Zhao ◽

Thi Phuong Hoa Dinh ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Exclusive Breastfeeding ◽

Mobile Application ◽

Controlled Trial ◽

Mobile App ◽

Control Group ◽

Block Randomisation ◽

Group A ◽

Randomised Controlled ◽

And Control

Breastfeeding provides benefits to the infant and mother; however, the rates of breastfeeding, particularly exclusive breastfeeding, remain below optimal levels in many Asian countries. The aim of this study is to review the benefits of breastfeeding to mothers and infants and current rates of breastfeeding in Vietnam, and to evaluate the effectiveness of a mobile application on exclusive breastfeeding among mothers in Vietnam. A two-arm, parallel triple-blinded randomised controlled trial will be conducted among 1000 mothers in Hanoi City, Vietnam, during 2020–2021. Eligible participants are pregnant women who will seek antenatal care from health facilities at 24–36 weeks of gestation and plan to deliver at two participating hospitals, own a smartphone, and carry a singleton foetus. Permuted-block randomisation method stratified by maternal age, education and parity will be used to ensure an equal number of participants in each group. A smartphone app will be developed to deliver breastfeeding and non-breastfeeding information to the intervention and control group, respectively. Data will be collected at baseline, before hospital discharge, and at 1, 4, and 6 months postpartum. This study envisages demonstrating whether a smartphone-based intervention can be effective at improving breastfeeding in Vietnam. Trials registration: ACTRN12619000531112.

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