Randomised Controlled Trial of a Pediatric Tracheostomy Care Education Program for Homecare Nurses

Objective: To evaluate the immediate and sustained knowledge retention and sense of self-efficacy of homecare nurses following completion of a standardized competency-based tracheostomy education course. Safe discharge of children requiring tracheostomy with or without ventilation relies on the competence of homecare nurses. Study Design: Pragmatic, randomized controlled trial of 44 homecare nurses. Participants were randomized into the intervention group (n=21), which received the tracheostomy course, or the control group (n=23), which received an enterostomy and vascular access course. Multiple-choice question (MCQ) knowledge assessments and self-efficacy questionnaires were administered to both groups pre-course and post-course at 6 week, 3 month, 6 month, and 12 month follow-ups. Results: Twenty participants in the intervention group and 19 in the control group were included. Four withdrew from the study and two crossed over from the control into the intervention arm. The change in mean self-efficacy scores (total score = 100) was significantly higher in the intervention group than in the control group at 6 weeks (intervention (mean ± SD): 18.6±14.5; control: 6.6±20.4; p=0.04) and 3 months (intervention: 19.6±14.2; control: 5.2±17.0; p=0.007), and trended higher at 6 months (intervention: 18.0±14.5; control: 6.9±24.1; p=0.1) and 12 months (intervention: 16.9±15.0; control: 16.8±20.5; p=1.0). The change in mean MCQ assessment scores (total score = 20) trended higher in the intervention group than in the control group at 6 weeks (intervention (mean ± SD): 1.8±2.2; control: 1.6, ±2.9; p=0.8). Conclusions: Homecare nurses who attended the tracheostomy course demonstrated a higher sense of self-efficacy at long-term follow-up.

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A Long-Term Follow-Up Programme for Maintenance of Motor Function after Stroke: Protocol of the life after Stroke—The LAST Study

Stroke Research and Treatment ◽

10.1155/2012/392101 ◽

2012 ◽

Vol 2012 ◽

pp. 1-7 ◽

Cited By ~ 8

Author(s):

Torunn Askim ◽

Birgitta Langhammer ◽

Hege Ihle-Hansen ◽

Jon Magnussen ◽

Torgeir Engstad ◽

...

Keyword(s):

Motor Function ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Stroke Severity ◽

Stroke Patients ◽

Long Term Follow Up ◽

Randomised Controlled

Background. There are no evidence-based strategies that have been shown to be superior in maintaining motor function for months to years after the stroke. The LAST study therefore intends to assess the effect of a long-term follow-up program for stroke patients compared to standard care on function, disability and health.Design. This is a prospective, multi-site randomised controlled trial, with blinded assessment 18 months after inclusion. A total of 390 patients will be recruited and randomised to a control group, receiving usual care, or to an intervention group 10 to 16 weeks after onset of stroke. Patients will be stratified according to stroke severity, age above 80, and recruitment site. The intervention group will receive monthly coaching on physical activity by a physiotherapist for 18 consecutive months after inclusion.Outcomes. The primary outcome is motor function (Motor Assessment Scale) 18 months after inclusion. Secondary outcomes are: dependency, balance, endurance, health-related quality of life, fatigue, anxiety and depression, cognitive function, burden on caregivers, and health costs. Adverse events and compliance to the intervention will be registered consecutively during follow-up.

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Developing Wellbeing Through a Randomised Controlled Trial of a Martial Arts Based Intervention: An Alternative to the Anti-Bullying Approach

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16010081 ◽

2018 ◽

Vol 16 (1) ◽

pp. 81 ◽

Cited By ~ 5

Author(s):

Brian Moore ◽

Stuart Woodcock ◽

Dean Dudley

Keyword(s):

Randomised Controlled Trial ◽

Secondary School ◽

Martial Arts ◽

Self Efficacy ◽

Controlled Trial ◽

Intervention Group ◽

Social Intervention ◽

Control Group ◽

School Students ◽

Randomised Controlled

Anti-bullying policies and interventions are the main approach addressing bullying behaviours in Australian schools. However, the evidence supporting these approaches is inconsistent and its theoretical underpinning may be problematic. The current study examined the effects of a martial arts based psycho-social intervention on participants’ ratings of resilience and self-efficacy, delivered as a randomised controlled trial to 283 secondary school students. Results found a consistent pattern for strengths-based wellbeing outcomes. All measures relating to resilience and self-efficacy improved for the intervention group, whereas results declined for the control group. These findings suggest that a martial arts based psycho-social intervention may be an efficacious method of improving wellbeing outcomes including resilience and self-efficacy. The study proposes utilising alternatives to the anti-bullying approach and that interventions should be aimed towards helping individuals develop strengths and cope more effectively, which has specific relevance to bullying and more generalised importance to positive mental health.

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Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-040108 ◽

2020 ◽

Vol 10 (12) ◽

pp. e040108

Author(s):

Rowan W Johnson ◽

Sian A Williams ◽

Daniel F Gucciardi ◽

Natasha Bear ◽

Noula Gibson

Keyword(s):

Exercise Prescription ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Programme ◽

Home Exercise ◽

Control Group ◽

Neurodevelopmental Disabilities ◽

Home Exercise Programme ◽

Exercise Programmes ◽

Randomised Controlled

ObjectiveDetermine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods.DesignSingle-blinded, parallel-groups, randomised controlled trial (RCT).SettingIntervention took place in participants’ homes in Western Australia.ParticipantsChildren aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services.InterventionAll participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group.Primary outcome measuresAdherence to exercise programme, goal achievement and exercise performance.Secondary outcome measuresEnjoyment, confidence and usability of Physitrack.ResultsFifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference −7.0% (95% CI: −21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events.ConclusionPhysitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods.Trial registration detailsAustralian New Zealand Clinical Trials Registry; ACTRN12616000743460.

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A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

BMC Public Health ◽

10.1186/s12889-021-11357-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

M. A. Greidanus ◽

A. E. de Rijk ◽

A. G. E. M. de Boer ◽

M. E. M. M. Bos ◽

P. W. Plaisier ◽

...

Keyword(s):

Return To Work ◽

Cancer Survivors ◽

Controlled Trial ◽

Intervention Group ◽

Work Outcomes ◽

Feasibility Trial ◽

Control Group ◽

Secondary Effect ◽

Quality Of Working Life ◽

Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

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Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

Health Informatics Journal ◽

10.1177/1460458221996409 ◽

2021 ◽

Vol 27 (1) ◽

pp. 146045822199640

Author(s):

Faranak Kazemi Majd ◽

Vahideh Zarea Gavgani ◽

Ali Golmohammadi ◽

Ali Jafari-Khounigh

Keyword(s):

Randomized Controlled Trial ◽

Hospital Readmission ◽

Medical Information ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Long Term Follow Up ◽

Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

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Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol

BMJ Open ◽

10.1136/bmjopen-2018-026086 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026086

Author(s):

Yasutake Tomata ◽

Fumiya Tanji ◽

Dieta Nurrika ◽

Yingxu Liu ◽

Saho Abe ◽

...

Keyword(s):

Financial Incentives ◽

Primary Outcome ◽

Financial Incentive ◽

Controlled Trial ◽

Intervention Group ◽

Sample Size Calculation ◽

Community Dwelling ◽

Control Group ◽

Modifiable Factors ◽

Randomised Controlled

IntroductionPhysical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan.Methods and analysisThis study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4–6 weeks and 7–9 weeks) relative to the average number of daily steps at the baseline (1–3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps.Ethics and disseminationThis study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal.Trial registration numberUMIN000033276; Pre-results.

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Effect of Engaging Trainees by Assessing Peer Performance: A Randomised Controlled Trial Using Simulated Patient Scenarios

BioMed Research International ◽

10.1155/2014/610591 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7 ◽

Cited By ~ 5

Author(s):

Charlotte Loumann Krogh ◽

Charlotte Ringsted ◽

Charles B. Kromann ◽

Maria Birkvad Rasmussen ◽

Tobias Todsen ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Global Rating ◽

Training Performance ◽

Significant Difference ◽

Training Format ◽

Peer Performance ◽

And Performance ◽

Randomised Controlled

Introduction. The aim of this study was to explore the learning effect of engaging trainees by assessing peer performance during simulation-based training.Methods. Eighty-four final year medical students participated in the study. The intervention involved trainees assessing peer performance during training. Outcome measures were in-training performance and performance, both of which were measured two weeks after the course. Trainees’ performances were videotaped and assessed by two expert raters using a checklist that included a global rating. Trainees’ satisfaction with the training was also evaluated.Results. The intervention group obtained a significantly higher overall in-training performance score than the control group: mean checklist score 20.87 (SD 2.51) versus 19.14 (SD 2.65)P=0.003and mean global rating 3.25 SD (0.99) versus 2.95 (SD 1.09)P=0.014. Postcourse performance did not show any significant difference between the two groups. Trainees who assessed peer performance were more satisfied with the training than those who did not: mean 6.36 (SD 1.00) versus 5.74 (SD 1.33)P=0.025.Conclusion. Engaging trainees in the assessment of peer performance had an immediate effect on in-training performance, but not on the learning outcome measured two weeks later. Trainees had a positive attitude towards the training format.

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Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽

10.1093/qjmed/hcab115.005 ◽

2021 ◽

Vol 114 (Supplement_1) ◽

Author(s):

Hatem Hussein El-Gamal ◽

Walid El-Basuony Mohammad ◽

Ahmed Samir Mohamed Zeerban

Keyword(s):

Quality Of Life ◽

Caesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Expectant Management ◽

Control Group ◽

Randomised Controlled ◽

Caesarean Scar Defect ◽

Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

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Effectiveness of one-to-one peer support for patients with severe mental illness – a randomised controlled trial

European Psychiatry ◽

10.1016/j.eurpsy.2016.12.007 ◽

2017 ◽

Vol 42 ◽

pp. 103-110 ◽

Cited By ~ 39

Author(s):

C.I. Mahlke ◽

S. Priebe ◽

K. Heumann ◽

A. Daubmann ◽

K. Wegscheider ◽

...

Keyword(s):

Mental Illness ◽

Peer Support ◽

Self Efficacy ◽

Controlled Trial ◽

Intervention Group ◽

Treatment As Usual ◽

Secondary Outcomes ◽

One To One ◽

Randomised Controlled

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.

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The side effects of service changes: exploring the longitudinal impact of participation in a randomised controlled trial (DOORWAYS) on staff perceptions of barriers to change

10.21203/rs.2.12594/v1 ◽

2019 ◽

Author(s):

Caroline Laker ◽

Matteo Cella ◽

Felicity Callard ◽

Til Wykes

Keyword(s):

Mental Health ◽

Controlled Trial ◽

Occupational Status ◽

Intervention Group ◽

Direct Care ◽

Care Staff ◽

Control Group ◽

Staff Perceptions ◽

Barriers To Change ◽

Randomised Controlled

Abstract Background Staff and service users have expressed concerns that service improvements in U.K. mental health wards have been slow or transient. It is possible that certain changes are positive for some (e.g. service users), but negative for others (e.g. staff), which may affect implementation success. In this study, we explore whether a programme of change to improve the therapeutic milieu on mental health wards influenced staff perceptions of barriers to change, 12 months after implementation. Method A cluster randomised controlled trial called DOORWAYS was conducted on eight inner-city U.K. acute mental health wards. Randomisation was achieved using a list randomly generated by a computer. A psychologist trained ward staff (mainly nurses) to deliver evidence-based groups and supported their initial implementation. The impact of these changes was measured over 12 months (when 4 wards were randomised), according to nurses’ perceptions of barriers to change (VOCALISE), using unstructured multivariate linear regression models. This innovative analysis method allows maximum use of data in randomised controlled trials with reduced sample sizes due to substantial drop out rates. The contextual influences of occupational status (staff) and of workplace setting (ward) were also considered. Results Staff who participated in the intervention had significantly worse perceptions of barriers to change at follow up. The perceptions of staff in the control group did not change over time. In both groups (N=120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward. Across time, direct care staff in the intervention group became more negative than those in the control group. Conclusion Participation in this program of change, worsened staff perceptions of barriers to change. In addition, occupational status (being from the direct care group) had a negative effect on perceptions of barriers to change, an effect that continued across time and was worse in the intervention group. Those providing direct care should be offered extra support when changes are introduced and through the implementation process. More effort should be placed around reducing the perceived burden of innovation for staff in mental health wards.

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