scholarly journals Makes FLASH the difference between the intervention group and the treatment-as-usual group in an evaluation study of a structured education and treatment programme for flash glucose monitoring devices in people with diabetes on intensive insulin therapy: study protocol for a randomised controlled trial

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Melanie Schipfer ◽  
Carmen Albrecht ◽  
Dominic Ehrmann ◽  
Thomas Haak ◽  
Bernd Kulzer ◽  
...  
2007 ◽  
Vol 191 (6) ◽  
pp. 548-553 ◽  
Author(s):  
Gregory L. Carter ◽  
Kerrie Clover ◽  
Ian M. Whyte ◽  
Andrew H. Dawson ◽  
Catherine D'Este

BackgroundRepetition of self-poisoning is common.AimsTo report the 24-month outcomes of a non-obligatory postcard intervention (plus treatment as usual) compared with treatment as usual.MethodIn a randomised-controlled trial (Zelen design) conducted in Newcastle, Australia, eight postcards were sent to participants over a 12-month period. The principal outcomes were the proportion of participants with one or more repeat episodes of self-poisoning and the number of repeat episodes per person.ResultsNo significant reduction was observed in the proportion of people repeating self-poisoning in the intervention group (21.2%, 95% CI 17.0–25.3) compared with the control group (22.8%, 95% CI 18.7–27.0;χ2=0.32, d.f. = 1,P= 0.57); the difference between groups was −1.7% (95% CI −7.5 to 4.2). There was a significant reduction in the rate of repetition, with an incidence risk ratio of 0.49 (95% CI 0.33–0.73).ConclusionsA postcard intervention maintained the halving of the rate of repetition of hospital-treated self-poisoning events over a 2-year period, although it did not significantly reduce the proportion of individuals who repeated self-poisoning.


2017 ◽  
Vol 42 ◽  
pp. 103-110 ◽  
Author(s):  
C.I. Mahlke ◽  
S. Priebe ◽  
K. Heumann ◽  
A. Daubmann ◽  
K. Wegscheider ◽  
...  

AbstractBackgroundOne-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments.MethodsThis is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years’ duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations.ResultsPatients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses.ConclusionsThe findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.


2013 ◽  
Vol 202 (5) ◽  
pp. 372-380 ◽  
Author(s):  
Gregory L. Carter ◽  
Kerrie Clover ◽  
Ian M. Whyte ◽  
Andrew H. Dawson ◽  
Catherine D'Este

BackgroundRepetition of hospital-treated self-poisoning and admission to psychiatric hospital are both common in individuals who self-poison.AimsTo evaluate efficacy of postcard intervention after 5 years.MethodA randomised controlled trial of individuals who have self-poisoned: postcard intervention (eight in 12 months) plus treatment as usualv.treatment as usual. Our primary outcomes were self-poisoning admissions and psychiatric admissions (proportions and event rates).ResultsThere was no difference between groups for any repeat-episode self-poisoning admission (intervention group: 24.9%, 95% CI 20.6-29.5; control group: 27.2%, 95% CI 22.8-31.8) but there was a significant reduction in event rates (incidence risk ratio (IRR)=0.54, 95% CI 0.37-0.81), saving 306 bed days. There was no difference for any psychiatric admission (intervention group: 38.1%, 95% CI 33.1-43.2; control group: 35.5%, 95% CI 30.8-40.5) but there was a significant reduction in event rates (IRR=0.66, 95% CI 0.47-0.91), saving 2565 bed days.ConclusionsA postcard intervention halved self-poisoning events and reduced psychiatric admissions by a third after 5 years. Substantial savings occurred in general hospital and psychiatric hospital bed days.


2018 ◽  
Vol 5 (5) ◽  
pp. 1767 ◽  
Author(s):  
Anitha M. Balachandran ◽  
Mangala Bharathi S. ◽  
Kumutha J.

Background: Aqueous chlorhexidine applied repeatedly may predispose to increased gram negative bacterial colonization in preterm skin due to its higher bactericidal action against gram positive bacteria and absence of alcohol. The objective was to study the difference in rates of gram negative bacterial colonization in skin swabs taken from axilla and groin on day 7 after multiple applications of 0.5% aqueous chlorhexidine and placebo (sterile water).Methods: Double blinded, randomised controlled trial recruiting preterm infants(28-34weeks) weighing ≥1000grams, stratified(28-31:32-34week) and randomly allocated to receive multiple body cleansing every 48hours starting from 6hours within birth during first postnatal week. Intervention group received cleansing with 0.5%chlorhexidine wipes and controls cleansed with similar looking sterile water wipes. Comparison of Proportions of swabs showing Gram negative bacterial growth in swabs taken from axilla and groin on day 7 of life after 3 cleansings (primary), at recruitment, 24 and 48 hours after first cleansing (secondary) were outcomes measured.Results: Of 137 eligible neonates, 120 enrolled and 59 infants received chlorhexidine cleansing and 61 received sterile water. At the end of first week, the rate of skin colonization with gram negative bacteria after multiple applications of 0.5% aqueous chlorhexidine was comparable with sterile water cleansing in both axilla (40.9% vs 51.1%, p=0.432) and groin (60.7% vs 54.3%, p=0.592). There was no difference in the rate of gram negative bacterial colonization in axilla and groin skin at 24 and 48 hours after single application also.Conclusions: Aqueous chlorhexidine even after multiple cleansings at 48hours intervals soon after birth has not predisposed to colonization with gram negative bacterial in preterm infants admitted in NICU.


2019 ◽  
Author(s):  
Joe Brew ◽  
Margaret Pinder ◽  
Umberto Dalessandro ◽  
Steven W Lindsay ◽  
Carloine Jones ◽  
...  

Abstract Background Recording behaviours that have the potential to impact health can be doubly challenging if the behaviour takes place in private spaces that cannot be observed directly and where there is potential for social desirability bias, i.e. where the respondent may give an answer that they think the recorder wants to hear. Sleeping under a long-lasting insecticidal net (LLIN) is an important intervention for malaria prevention, yet it is difficult to gauge the extent to which coverage (how many nets are in the community) differs from usage (how many people sleep under a net). We employed a novel method, list randomization, which partially obscures respondents' answers to sensitive questions, as a mean to provide an accurate estimate of LLIN usage in The Gambia.Methods We surveyed 196 residents from 196 households recruited into a randomised controlled trial assessing the effect of a housing intervention on malaria. In the current experiment, 98 of the 196 study participants were randomly assigned to the control group and received a four-question list about non-sensitive behaviours; the other participants in the intervention group, received the same list, with the addition of one question on a sensitive behaviour; whether or not they had used a bednet the previous night. Participants were read the list of questions and then said how many of the statements were true. We estimated bednet usage by calculating the difference in means between the total number of affirmative items between the two groups, and quantified uncertainty using a t-test.Results The mean number of affirmative responses in the control group was 2.60 of four statements (95% confidence interval, 95% CI, = 2.50-2.70), compared with 3.68 (95% CI = 3.59-3.78) in the intervention group. Such difference (1.08; 95% CI = 94.9-100%) suggests approximately 100% bednet usage.Conclusions Our findings suggest complete universal bednet usage in the study area. Further validation of the list randomization method in areas with lower net coverage is required.


2010 ◽  
Vol 196 (5) ◽  
pp. 404-411 ◽  
Author(s):  
Louise M. Howard ◽  
Margaret Heslin ◽  
Morven Leese ◽  
Paul McCrone ◽  
Christopher Rice ◽  
...  

BackgroundThere is evidence from North American trials that supported employment using the individual placement and support (IPS) model is effective in helping individuals with severe mental illness gain competitive employment. There have been few trials in other parts of the world.AimsTo investigate the effectiveness and cost-effectiveness of IPS in the UK.MethodIndividuals with severe mental illness in South London were randomised to IPS or local traditional vocational services (treatment as usual) (ISRCTN96677673).ResultsTwo hundred and nineteen participants were randomised, and 90% assessed 1 year later. There were no significant differences between the treatment as usual and intervention groups in obtaining competitive employment (13% in the intervention group and 7% in controls; risk ratio 1.35, 95% CI 0.95–1.93, P = 0.15), nor in secondary outcomes.ConclusionsThere was no evidence that IPS was of significant benefit in achieving competitive employment for individuals in South London at 1-year follow-up, which may reflect suboptimal implementation. Implementation of IPS can be challenging in the UK context where IPS is not structurally integrated with mental health services, and economic disincentives may lead to lower levels of motivation in individuals with severe mental illness and psychiatric professionals.


BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e038354
Author(s):  
Kirrily Ellerton ◽  
Harishan Tharmarajah ◽  
Rimma Medres ◽  
Lona Brown ◽  
David Ringelblum ◽  
...  

IntroductionPain caused by routine immunisations is distressing to children, their parents and those administering injections. If poorly managed, it can lead to anxiety about future medical procedures, needle phobia and avoidance of future vaccinations and other medical treatment. Several strategies, such as distraction, are used to manage the distress associated with routine immunisations. Virtual reality (VR), a technology which transports users into an immersive ‘virtual world’, has been used to manage pain and distress in various settings such as burns dressing changes and dental treatments. In this study, we aim to compare the effectiveness of VR to standard care in a general practice setting as a distraction technique to reduce pain and distress in 4-year-old children receiving routine immunisations.Methods and analysisThe study is a randomised controlled clinical trial comparing VR with standard care in 100 children receiving routine 4-year-old vaccination. Children attending a single general practice in metropolitan Melbourne, Australia will be allocated using blocked randomisation to either VR or standard care. Children in the intervention group will receive VR intervention prior to vaccination in addition to standard care; the control group will receive standard care. The primary outcome is the difference in the child’s self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised. Secondary outcomes include another measure of self-rated pain (the Poker Chip Tool), parent/guardian and healthcare provider ratings of pain (standard 100 mm visual analogue scales) and adverse effects.Ethics and disseminationEthics approval has been obtained in Australia from the Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (NREEC 18-010). Recruitment commenced in July 2019. We plan to submit study findings for publication in a peer-reviewed journal and presentation at relevant conferences.Trial registration numberACTRN12618001363279.


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