scholarly journals Effects of two types of smartphone-based stress management programmes on depressive and anxiety symptoms among hospital nurses in Vietnam: a protocol for three-arm randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e025138 ◽  
Author(s):  
Kotaro Imamura ◽  
Thuy Thi Thu Tran ◽  
Huong Thanh Nguyen ◽  
Kazuto Kuribayashi ◽  
Asuka Sakuraya ◽  
...  
Keyword(s):  
Stress Management ◽  
Free Choice ◽  
Controlled Trial ◽  
Intervention Group ◽  
Anxiety Symptoms ◽  
Control Group ◽  
Hospital Nurses ◽  
Management Intervention ◽  
Stress Management Intervention ◽  
Randomised Controlled

IntroductionDue to an increasing demand for healthcare in low-income and middle-income countries in Asia, it is important to develop a strategy to manage work-related stress in healthcare settings, particularly among nurses in these countries. The purpose of this three-arm randomised controlled trial (RCT) is to examine the effects of a newly developed smartphone-based multimodule stress management programme on reducing severity of depressive and anxiety symptoms as primary outcomes at 3-month and 7-month follow-ups among hospital nurses in Vietnam.Methods and analysisThe target study population will be registered nurses working in a large general hospital (which employs approximately about 2000 nurses) in Vietnam. They will be invited to participate in this study. Participants who fulfil the eligibility criteria will be randomly allocated to the free-choice, multimodule stress management (intervention group A, n=360), the internet cognitive behavioural therapy (iCBT), that is, fixed-order stress management (intervention group B, n=360), or a treatment as usual control group (n=360). Two types (free-choice and fixed sequential order) of smartphone-based six-module stress management programmes will be developed. Participants in the intervention groups will be required to complete one of the programmes within 10 weeks after the baseline survey. The primary outcomes are depressive and anxiety symptoms, measured by using the Depression Anxiety and Stress Scales (DASS) at 3-month and 7 month follow-ups.Ethics and disseminationThe study procedures have been approved by the Research Ethics Review Board of Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (no 11991) and the Ethical Review Board for Biomedical Research of Hanoi University of Public Health (no 346/2018/YTCC-HD3). If a significant effect of the intervention programmes will be found in the RCT, the programmes will be made available to all nurses in the hospital including the control group. If the positive effects are found in this RCT, the e-stress management programmes will be disseminated to all nurses in Vietnam.Trial registration numberUMIN000033139; Pre-results.

scholarly journals Effectiveness of a medication adherence management intervention in a community pharmacy setting: a cluster randomised controlled trial

2021 ◽  
pp. bmjqs-2020-011671
Author(s):  
Andrea Torres-Robles ◽  
Shalom I Benrimoj ◽  
Miguel Angel Gastelurrutia ◽  
Fernando Martinez-Martinez ◽  
Tamara Peiro ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Community Pharmacist ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Management Intervention ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
Adherence Management

BackgroundNon-adherence to medications continues to be a burden worldwide, with significant negative consequences. Community pharmacist interventions seem to be effective at improving medication adherence. However, more evidence is needed regarding their impact on disease-specific outcomes. The aim was to evaluate the impact of a community pharmacist-led adherence management intervention on adherence and clinical outcomes in patients with hypertension, asthma and chronic obstructive pulmonary disease (COPD).MethodsA 6-month cluster randomised controlled trial was conducted in Spanish community pharmacies. Patients suffering from hypertension, asthma and COPD were recruited. Patients in the intervention group received a medication adherence management intervention and the control group received usual care. The intervention was based on theoretical frameworks for changing patient behaviour. Medication adherence, disease-specific outcomes (Asthma Control Questionnaire (ACQ) scores, Clinical COPD Questionnaire (CCQ) scores and blood pressure levels) and disease control were evaluated. A multilevel regression model was used to analyse the data.ResultsNinety-eight pharmacies and 1186 patients were recruited, with 1038 patients completing the study. Patients receiving the intervention had an OR of 5.12 (95% CI 3.20 to 8.20, p<0.05) of being adherent after the 6 months. At the end of the study, patients in the intervention group had lower diastolic blood pressure levels (mean difference (MD) −2.88, 95% CI −5.33 to −0.43, p=0.02), lower CCQ scores (MD −0.50, 95% CI −0.82 to −0.18, p<0.05) and lower ACQ scores (MD −0.28, 95% CI −0.56 to 0.00, p<0.05) when compared with the control group.ConclusionsA community pharmacist-led medication adherence intervention was effective at improving medication adherence and clinical outcomes in patients suffering from hypertension, asthma and COPD. Future research should explore the implementation of these interventions in routine practice.Trial registration numberACTRN12618000410257.

scholarly journals Effect of smartphone-based stress management programs on depression and anxiety of hospital nurses in Vietnam: a three-arm randomized controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Kotaro Imamura ◽  
Thuy Thi Thu Tran ◽  
Huong Thanh Nguyen ◽  
Natsu Sasaki ◽  
Kazuto Kuribayashi ◽  
...  
Keyword(s):  
Stress Management ◽  
Group Treatment ◽  
Free Choice ◽  
Anxiety Symptoms ◽  
Control Group ◽  
Hospital Nurses ◽  
Group Randomized Trial ◽  
Small Effect Size ◽  
Fixed Order

AbstractThere are growing concerns on stress among nurses in low- and middle-income countries (LMICs) in South-East Asia. It is important to improve mental health among nurses in these countries. The objective of this study was to examine the efficacy of two types of newly developed smartphone-based stress management programs in improving depressive and anxiety symptoms among hospital nurses in Vietnam. This study was a three-arm (including two intervention groups and one control group) randomized trial. Participants were recruited from nurses in a large general hospital in Hanoi, Vietnam. Two types (free-choice and fixed sequential order) of smartphone-based stress management programs were developed. Participants were randomly allocated to Program A (a free-choice, multimodule stress management), Program B (a fixed-order, internet cognitive behavioral therapy, iCBT), or a control group (treatment as usual). The depressive and anxiety symptoms were measured by using the Depression Anxiety and Stress Scales at baseline, 3-, and 7-month follow-up surveys. 951 participants were randomly allocated to each of the three groups. Program B showed a statistically significant effect on improving depressive symptoms at 3-month (p = 0.048), but not at 7-month (p = 0.92); Cohen’s d was − 0.18 (95% CI − 0.34 to − 0.02) and 0.03 (95% CI − 1.00 to 1.05), respectively. Program A failed to show a significant intervention effect on any of the outcomes at 3- or 7-month follow-up (p > 0.05). Despite the small effect size, the present fixed-order iCBT program seems effective in improving depression of hospital nurses in Vietnam. A public health impact of the intervention can be scalable, when considering its accessibility and minimal cost.Trial registration number: The study protocol is registered at the UMIN Clinical Trials Registry (UMINCTR; ID = UMIN000033139). Registered date of the protocol is 1st Jul. 2018. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037796

scholarly journals 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 ◽  
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.

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

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).

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

BMJ Open ◽  
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.

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

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
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.

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

QJM ◽  
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.

scholarly journals 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

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.

scholarly journals Multicentre, randomised controlled trial of PDSAFE, a physiotherapist-delivered fall prevention programme for people with Parkinson’s

2019 ◽  
Vol 90 (7) ◽  
pp. 774-782 ◽  
Author(s):  
Kim Chivers Seymour ◽  
Ruth Pickering ◽  
Lynn Rochester ◽  
Helen C Roberts ◽  
Claire Ballinger ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Fall Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Prevention Programme ◽  
Control Group ◽  
Chair Stand ◽  
Subgroup Analyses ◽  
Randomised Controlled ◽  
Fall Prevention Programme

ObjectiveTo estimate the effect of a physiotherapist-delivered fall prevention programme for people with Parkinson’s (PwP).MethodsPeople at risk of falls with confirmed Parkinson’s were recruited to this multicentre, pragmatic, investigator blind, individually randomised controlled trial with prespecified subgroup analyses. 474 PwP (Hoehn and Yahr 1–4) were randomised: 238 allocated to a physiotherapy programme and 236 to control. All participants had routine care; the control group received a DVD about Parkinson’s and single advice session at trial completion. The intervention group (PDSAFE) had an individually tailored, progressive home-based fall avoidance strategy training programme with balance and strengthening exercises. The primary outcome was risk of repeat falling, collected by self-report monthly diaries, 0–6 months after randomisation. Secondary outcomes included Mini-BESTest for balance, chair stand test, falls efficacy, freezing of gait, health-related quality of life (EuroQol EQ-5D), Geriatric Depression Scale, Physical Activity Scale for the Elderly and Parkinson’s Disease Questionnaire, fractures and rate of near falling.ResultsAverage age is 72 years and 266 (56%) were men. By 6 months, 116 (55%) of the control group and 125 (61.5%) of the intervention group reported repeat falls (controlled OR 1.21, 95% CI 0.74 to 1.98, p=0.447). Secondary subgroup analyses suggested a different response to the intervention between moderate and severe disease severity groups. Balance, falls efficacy and chair stand time improved with near falls reduced in the intervention arm.ConclusionPDSAFE did not reduce falling in this pragmatic trial of PwP. Other functional tasks improved and reduced fall rates were apparent among those with moderate disease.Trial registration numberISRCTN48152791.

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