scholarly journals 71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

2020 ◽  
Vol 37 (12) ◽  
pp. 835.3-836
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Gordon Taylor ◽  
Daryl Wood ◽  
Karen Knapp
Keyword(s):  
Data Collection ◽  
Controlled Trial ◽  
Wrist Fracture ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Point Of Care Ultrasound ◽  
Distal Radial Fractures ◽  
Definitive Trial ◽  
Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

scholarly journals Promoting independence in dementia: protocol for a feasibility trial of the PRIDE intervention for living well with dementia

2018 ◽  
Vol 5 (4) ◽  
pp. 177 ◽  
Author(s):  
Emese Csipke ◽  
Lauren Yates ◽  
Esme Moniz Cook ◽  
Phuong Leung ◽  
Georgina Charlesworth ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Measure Data ◽  
Structured Interviews ◽  
Post Intervention ◽  
Mild Dementia ◽  
Living Well ◽  
People With Dementia ◽  
Randomised Controlled

<p class="abstract"><strong>Background:</strong> Dementia can lead to social exclusion, loss of identity and independence, due to deterioration in cognition and activities of daily living. The aim of the study is to investigate the feasibility of the Promoting Independence in Dementia (PRIDE) intervention, designed to facilitate independence in people with mild dementia.</p><p class="abstract"><strong>Methods:</strong> This is a mixed-methods feasibility trial of the PRIDE, in preparation for a future randomised controlled trial. Up to 50 people with dementia will be recruited. Demetia advisors will deliver the three session intervention. Quantitative outcomes will be taken at baseline and up to three months post baseline. Fidelity checklists will assess fidelity to the intervention. Qualitative implementation data will be gathered in a series of post-intervention semi-structured interviews with staff and participants. This will include data to examine participant experiences of and engagement with the intervention, and other aspects of delivery such as recruitment of DAWs, fidelity and experiences of receiving and delivering the intervention. This study aims to establish and field test the PRIDE intervention; determine the recruitment rate of sites, providers and participants; assess fidelity in delivery of the intervention and engagement with people with dementia; assess the feasibility and acceptability of outcome measure data and assess the acceptability of the intervention by stakeholders.</p><p class="abstract"><strong>Conclusions: </strong>There has been increased need for non-pharmacological interventions for mild dementia. The results of this feasibility study will allow us to plan for a definitive RCT of a three session dementia advisor led intervention for mild dementia.</p>

scholarly journals Psychological therapy for mood instability within bipolar spectrum disorder: a randomised, controlled feasibility trial of a dialectical behaviour therapy-informed approach (the ThrIVe-B programme)

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Kim Wright ◽  
Alyson L. Dodd ◽  
Fiona C. Warren ◽  
Antonieta Medina-Lara ◽  
Barnaby Dunn ◽  
...  
Keyword(s):  
Recruitment Rate ◽  
Spectrum Disorder ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Bipolar Spectrum ◽  
Behaviour Therapy ◽  
Treatment As Usual ◽  
Bipolar Spectrum Disorder ◽  
Randomised Controlled

Abstract Background A subgroup of those with bipolar spectrum disorders experience ongoing mood fluctuations outside of full episodes. We conducted a randomised, controlled feasibility study of a Dialectical Behavioural Therapy-informed approach for bipolar mood fluctuations (Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). Our study aimed to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost effectiveness of the ThrIVe-B programme. Participants were required to meet diagnostic criteria for a bipolar spectrum disorder and report frequent mood swings outside of acute episodes. They were randomised to treatment as usual (control arm) or the ThrIVe-B intervention plus treatment as usual (intervention arm). Follow-up points were at 3, 6, 9 and 15 months after baseline, with 9 months as the primary end point. To evaluate feasibility and acceptability we examined recruitment and retention rates, completion rates for study measures, adverse events and feedback from participants on their experience of study participation and therapy. Results Of the target 48 participants, 43 were recruited (22 in the intervention arm; 21 in the control arm), with a recruitment rate of 3.9 participants per month. At 9 months 74% of participants engaged in research follow-up assessment, exceeding the pre-specified criterion of 60%. There were no serious concerns about the safety of the research procedures or the intervention. On one of the four candidate primary outcome measures, the 95% CI for the between-group mean difference score excluded the null effect and included the minimal clinically important difference, favouring the intervention arm, whilst on no measure was there evidence of deterioration in the intervention arm relative to the control arm. Attendance of the intervention (50% attending at least half of the mandatory sessions) was below the pre-specified continuation criterion of 60%, and qualitative feedback from participants indicated areas that may have hampered or facilitated engagement. Conclusions It is broadly feasible to conduct a trial of this design within the population of people with frequent bipolar mood swings. Changes should be made to the therapy to increase uptake, such as simplifying content and considering individual rather than group delivery. Trial registration ISRCTN: ISRCTN54234300. Registered 14th July 2017, http://www.isrctn.com/ISRCTN54234300

scholarly journals Protocol for the Work Engagement and Well-being Study (SWELL): A randomised controlled feasibility trial evaluating the effects of mindfulness versus light physical exercise at work

2021 ◽  
Author(s):  
Maris Vainre ◽  
Julieta Galante ◽  
Peter Watson ◽  
Tim Dalgleish ◽  
Caitlin Hitchcock
Keyword(s):  
Physical Exercise ◽  
Work Performance ◽  
Controlled Trial ◽  
Well Being ◽  
Performance Outcomes ◽  
Feasibility Trial ◽  
Post Intervention ◽  
Randomised Controlled ◽  
Preventative Interventions

Mental ill health is a major cause of disability. Workplaces are attractive for preventative interventions since most adults work while employers are interested in improving employees’ well-being and productivity. Mindfulness-based programmes are increasingly in occupational settings. However, there is inconsistent evidence whether mindfulness interventions improve work performance and how effective mindfulness-based programmes are, compared to other interventions, in preventing mental ill health.In this online randomised controlled feasibility trial, an anticipated 240 employees will be randomised to either a 4-week light physical exercise course or a mindfulness course of the same duration (1:1 allocation). The primary outcome is work performance, measured using the Work Role Functioning Questionnaire. We aim to evaluate the acceptability, feasibility, and procedural uncertainties of a randomised controlled trial in a workplace, calculate an effect size estimate to inform power calculations for a larger trial, and explore whether improved executive function and/or enhanced mental health could be potential mechanisms underlying the effect of mindfulness on work performance. Outcomes will be collected at baseline, post-intervention and 12-week follow-up.

scholarly journals A feasibility cluster randomised controlled trial of a preschool obesity prevention intervention: ToyBox-Scotland

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Stephen Malden ◽  
John. J. Reilly ◽  
Ann-Marie Gibson ◽  
Farid Bardid ◽  
Carolyn Summerbell ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Obesity Prevention ◽  
Sedentary Time ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Recruitment Rate ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background High levels of childhood obesity have been observed globally over the last three decades. Preschools are promising settings to implement obesity prevention interventions in the early years. The aim of this study was to test the feasibility of a cluster randomised controlled trial of the ToyBox-Scotland preschool obesity prevention intervention. Methods Six preschools in predominantly deprived areas of Glasgow, UK, were randomised to either the ToyBox intervention (n = 3) or usual curriculum control group (n = 3). The intervention ran for 18 weeks from March–June 2018, and consisted of practitioner-led physical activity and sedentary behaviour sessions in preschools, with an additional interactive home component. Primary outcome measures were intervention fidelity, recruitment rates, attrition rates, and compliance with trial procedures. Secondary outcomes were body mass index (BMI) z-score, bioelectrical impedance analysis (BIA), objectively measured physical activity and sedentary time via activPAL accelerometer, and parent-reported home eating, snacking, and water consumption. Results The preschool component of the intervention was implemented with high fidelity (64%), while the home component was implemented with low fidelity (41%). A cluster-level recruitment rate of 10% was achieved, and the individual-level recruitment rate was 18% (42/233 children, mean age 4.4 years; 17 girls). The attrition rate was 14%, and compliance rates varied considerably by the outcome. Compliance was highest for BMI (86%), while 19% of the sample returned valid accelerometer data for both baseline and follow-up and the parental questionnaire response rate was 23%. Both intervention and control groups showed small increases in BMI z-scores at follow-up of 0.02 and 0.06, respectively. Both groups had small decreases in physical activity and increases in sedentary time at follow-up. Conclusions Before progression to an effectiveness trial, additional procedures should be considered to improve recruitment rates, compliance with outcome measures, and implementation of the home-based component of the ToyBox-Scotland intervention. Trial registration ISRCTN12831555

scholarly journals Effectiveness of a tailored rehabilitation versus standard strengthening programme for patients with shoulder pain: a protocol for a feasibility randomised controlled trial (the Otago MASTER trial)

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e028261
Author(s):  
Daniel C Ribeiro ◽  
Zohreh Jafarian Tangrood ◽  
Gisela Sole ◽  
J Haxby Abbott
Keyword(s):  
Randomised Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Recruitment Rate ◽  
Rehabilitation Programme ◽  
Drop Out ◽  
Feasibility Trial ◽  
Intervention Effects ◽  
Mixed Model Analysis ◽  
Randomised Controlled

IntroductionExercise therapy is the treatment of choice for the management of patients with shoulder subacromial pain. However, we do not know whether a tailored rehabilitation programme is more effective than a standardised strengthening programme. The aim of this feasibility trial is to assess: (1) participant recruitment rate, (2) the proportion of participants enrolled from the total number screened, (3) adherence to the rehabilitation programme, (4) drop-out rates, (5) obtain estimates of adverse reactions to treatment, (6) obtain estimates of intervention effects in order to inform the sample size of the fully-powered randomised controlled trial, (7) conduct a preliminary cost-effectiveness analysis of the standardised strengthening and the tailored rehabilitation interventions.MethodsThe MAnagement of Subacromial disorders of The shouldER (MASTER) trial, is a two-arm, patient-blinded and assessor-blinded, randomised controlled feasibility trial. Participants will be randomly allocated into one of the interventions group: tailored or standardised rehabilitation. To obtain estimates of intervention effects, we will compare changes in pain and shoulder-related disability scores between the two intervention groups using a repeated mixed-model analysis of variance, with alpha set at 0.05, and power at 80%. Since this is a feasibility study, we will not adjust alpha for multiple comparisons. To determine whether it is feasible to conduct the full trial, we will consider 75% CI as the probability threshold at 3-month follow-up.Ethics and disseminationThis study was approved by the University of Otago Ethics Committee (Ref: H17/080). Findings from this study will be presented at national and international conferences, and will be submitted for publication in a peer-reviewed journal.Trial registration numberANZCTR: 12617001405303

scholarly journals Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack)

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e016768 ◽  
Author(s):  
Adam W A Geraghty ◽  
Rosie Stanford ◽  
Beth Stuart ◽  
Paul Little ◽  
Lisa C Roberts ◽  
...  
Keyword(s):  
Primary Care ◽  
Usual Care ◽  
Controlled Trial ◽  
Internet Intervention ◽  
Feasibility Trial ◽  
Low Back ◽  
Telephone Support ◽  
Primary Care Patients ◽  
Randomised Controlled

ObjectiveTo determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support.Design and settingA three-armed randomised controlled feasibility trial conducted in 12 general practices in England.ParticipantsPrimary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness.InterventionsThe ‘SupportBack’ internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance.OutcomesThe primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up.ResultsPrimary outcomes: 87 patients with LBP were recruited (target 60–90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3 months follow-up was 84%.ConclusionsThis study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP.Trial registration numberISRCTN31034004; Results.

scholarly journals Morita Therapy for depression (Morita Trial): a pilot randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e021605 ◽  
Author(s):  
Holly Victoria Rose Sugg ◽  
David A Richards ◽  
Julia Frost
Keyword(s):  
Anxiety Disorder ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Control Groups ◽  
Morita Therapy ◽  
Dsm Iv ◽  
Randomised Controlled ◽  
And Control

ObjectiveTo address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible.DesignPilot parallel group randomised controlled feasibility trial.Setting and participantsParticipants aged ≥18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK.InterventionsWe randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8–12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention).OutcomesRates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores.ResultsWe recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). Of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively.ConclusionsA large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments.Trial registration numberISRCTN17544090; Pre-results.

scholarly journals Feasibility randomised controlled trial of a guided workbook intervention to support work-related goals among cancer survivors in the UK

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e022746 ◽  
Author(s):  
Elizabeth A Grunfeld ◽  
Lauren Schumacher ◽  
Maria Armaou ◽  
Pernille L Woods ◽  
Pauline Rolf ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Data Collection ◽  
Return To Work ◽  
Usual Care ◽  
Controlled Trial ◽  
Full Time ◽  
Patients With Cancer ◽  
Randomised Controlled

ObjectivesEmployment following illness is associated with better physical and psychological functioning. This study aimed to assess the feasibility and acceptability of a theoretically led workbook intervention designed to support patients with cancer returning to work.DesignParallel-group randomised controlled trial with embedded qualitative interviews.SettingOncology clinics within four English National Health Service Trusts.ParticipantsPatients who had received a diagnosis of breast, gynaecological, prostate or colorectal cancer and who had been receiving treatment for a minimum of two weeks.InterventionA self-guided WorkPlan workbook designed to support patients with cancer to return to work with fortnightly telephone support calls to discuss progress. The control group received treatment as usual and was offered the workbook at the end of their 12-month follow-up.Outcome measuresWe assessed aspects of feasibility including eligibility, recruitment, data collection, attrition, feasibility of the methodology, acceptability of the intervention and potential to calculate cost-effectiveness.ResultsThe recruitment rate of eligible patients was 44%; 68 participants consented and 58 (85%) completed baseline measures. Randomisation procedures were acceptable, data collection methods (including cost-effectiveness data) were feasible and the intervention was acceptable to participants. Retention rates at 6-month and 12-month follow-up were 72% and 69%, respectively. At 6-month follow-up, 30% of the usual care group had returned to full-time or part-time work (including phased return to work) compared with 43% of the intervention group. At 12 months, the percentages were 47% (usual care) and 68% (intervention).ConclusionsThe findings confirm the feasibility of a definitive trial, although further consideration needs to be given to increasing the participation rates among men and black and ethnic minority patients diagnosed with cancer.Trial registration numberISRCTN56342476; Pre-results.

scholarly journals Healthy Parent Carers: feasibility randomised controlled trial of a peer-led group-based health promotion intervention for parent carers of disabled children

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Gretchen Bjornstad ◽  
Beth Cuffe-Fuller ◽  
Obioha C. Ukoumunne ◽  
Mary Fredlund ◽  
Annabel McDonald ◽  
...  
Keyword(s):  
Trial Design ◽  
Controlled Trial ◽  
Online Resources ◽  
Community Settings ◽  
Post Intervention ◽  
Definitive Trial ◽  
Link Type ◽  
Randomised Controlled ◽  
Group Programme

Abstract Background Parent carers of children with special educational needs or disability are at higher risk of poor mental and physical health. The need for a tailored, peer-led group programme was raised by parent carers, who co-developed the Healthy Parent Carers programme with researchers. This study aimed to test the feasibility of programme delivery in community settings, and the feasibility and acceptability of a randomised controlled trial design. Methods Participants were individually randomised with concealed allocation to a structured group programme and access to online resources (intervention), or access to the online resources only (control). Measures of wellbeing and secondary and economic outcomes were collected before randomisation, immediately post-intervention, and 6 months post-intervention. Descriptive statistics on recruitment and attrition, demographics, attendance, and fidelity of intervention delivery were analysed with feedback on the acceptability of the trial design. Results One hundred and ninety-three parent carers expressed an interest in taking part. Ninety-two participants recruited from across six sites were randomised (47 intervention, 45 control). Lead and assistant facilitators were trained and delivered the group sessions. Sixteen (34%) participants in the intervention arm did not attend any sessions, and attendance varied across sites and sessions. One participant withdrew post-randomisation, and 83 (90%) participants completed outcome measures at the six-month follow-up. Conclusions The study demonstrated that it was feasible to deliver the programme in community settings. The number of parent carers who expressed interest signifies the need for such a programme and the feasibility of recruiting to a definitive trial. Loss to follow-up was low. Further research is needed to explore ways to reduce barriers to participation in person and assess the feasibility and acceptability of programme content and delivery for more ethnically diverse groups, and potentially using interpreters. Given the Covid-19 pandemic and delivery format feedback, there is also a need to investigate remote or blended delivery strategies. Although the results indicate that a definitive trial is feasible, programme impact would be strengthened through exploration of these uncertainties. Trial registration ISRCTN, ISRCTN15144652, registered on 25 October 2018, ClinicalTrials.gov, NCT03705221, registered on 15 October 2018.

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