scholarly journals Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES)

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e043699
Author(s):  
Morten Riemenschneider ◽  
Lars G Hvid ◽  
Steffen Ringgaard ◽  
Mikkel K E Nygaard ◽  
Simon F Eskildsen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Treatment Strategy ◽  
Controlled Trial ◽  
Treatment Strategies ◽  
Control Group ◽  
Disease Course ◽  
Disability Progression ◽  
Randomised Controlled

IntroductionIn the relapsing remitting type of multiple sclerosis (MS) reducing relapses and neurodegeneration is crucial in halting the long-term impact of the disease. Medical disease-modifying treatments have proven effective, especially when introduced early in the disease course. However, patients still experience disease activity and disability progression, and therefore, supplemental early treatment strategies are warranted. Exercise appear to be one of the most promising supplemental treatment strategies, but a somewhat overlooked ‘window of opportunity’ exist early in the disease course. The objective of this study is to investigate exercise as a supplementary treatment strategy early in the disease course of MS.Methods and analysisThe presented Early Multiple Sclerosis Exercise Study is a 48-week (plus 1-year follow-up) national multicentre single-blinded parallel group randomised controlled trial comparing two groups receiving usual care plus supervised high-intense exercise or plus health education (active control). Additionally, data will be compared with a population-based control group receiving usual care only obtained from the Danish MS Registry. The primary outcomes are annual relapse rate and MRI derived global brain atrophy. The secondary outcomes are disability progression, physical and cognitive function, MS-related symptoms, and exploratory MRI outcomes. All analyses will be performed as intention to treat.Ethics and disseminationThe study is approved by The Central Denmark Region Committees on Health Research Ethics (1-10-72-388-17) and registered at the Danish Data Protection Agency (2016-051-000001 (706)). All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.Trial registration numberNCT03322761.

scholarly journals Positive Mental Training in patients with Multiple Sclerosis experiencing psychological distress: A Preliminary Randomised Controlled Trial

2021 ◽  
Author(s):  
Katy Muray ◽  
Giulia Melchiorre ◽  
Alastair Dobbin ◽  
Killian A Welch
Keyword(s):  
Multiple Sclerosis ◽  
Psychological Distress ◽  
Randomised Controlled Trial ◽  
Low Cost ◽  
Controlled Trial ◽  
Control Group ◽  
Mental Training ◽  
Current Form ◽  
Self Rated Health ◽  
Randomised Controlled

Introduction: Psychological distress is a major issue in multiple sclerosis (MS), having a significant impact on quality of life. Antidepressants are generally unhelpful for subsyndromal symptomatology, and psychological treatment approaches often not accessible or too cognitively demanding for some patients. There is an urgent need for low-cost interventions to improve wellbeing in MS. Methods: This was a pilot randomised controlled trial (RCT) of Positive Mental Training (PosMT), a low intensity intervention providing training in positivity, optimism and resilience previously shown to improve anxious and depressive symptomotology. 28 patients with MS were randomised to the intervention and 30 to the control group. Results: Follow-up data was obtained from 39 patents. The majority of participants receiving PosMT reported that they had used the intervention, with few reporting side effects. The intervention group reported a significant improvement in self-rated health as measured by the EuroQual visual analogue scale, F(4,34) = 3.204, p = 0.025, R2 = 0.274. Discussion: This preliminary RCT found that PosMT in its current form could be used by patients with MS with little difficulty. Despite the small size of the study, allocation to the intervention was found to be associated with a significant improvement in self-rated health. Given the low cost of PosMT and its easy availability (it can simply be downloaded from a website), this pilot RCT suggests it could be a useful tool for MS patients. We believe this intervention warrants further study, ideally in a large multi-centre RCT.

scholarly journals Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e036496 ◽  
Author(s):  
Anna Lena Brorsson ◽  
Ewa-Lena Bratt ◽  
Philip Moons ◽  
Anna Ek ◽  
Elisabeth Jelleryd ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ethical Review ◽  
Control Group ◽  
Randomised Controlled

IntroductionAdolescence is a critical period for youths with chronic conditions, when they are supposed to take over the responsibility for their health. Type 1 diabetes (T1D) is one of the most common chronic conditions in childhood and inadequate self-management increases the risk of short-term and long-term complications. There is a lack of evidence regarding the effectiveness of transition programmes. As a part of the Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS research programme, the objective of this study is to evaluate the effectiveness and experiences of different transitional care models, including a person-centred transition programme aiming to empower adolescents with T1D to become active partners in their health and care.Methods and analysisIn this randomised controlled trial, patients are recruited from two paediatric diabetes clinics at the age of 16 years. Patients are randomly assigned to either the intervention group (n=70) where they will receive usual care plus the structured transition programme, or to the control group (n=70) where they will only receive usual care. Data will be collected at 16, 17 and 18.5 years of age. In a later stage, the intervention group will be compared with adolescents in a dedicated youth clinic in a third setting. The primary outcome is patient empowerment. Secondary outcomes include generic, diabetes-specific and transfer-specific variables.Ethics and disseminationThe study has been approved by the Ethical Review Board in Stockholm (Dnr 2018/1725-31). Findings will be reported following the Consolidated Standards of Reporting Trials statement and disseminated in peer-reviewed journals and at international conferences.Trial registration numberNCT03994536

scholarly journals Abstinence-contingent wage supplements to promote drug abstinence and employment: a randomised controlled trial

2020 ◽  
Vol 74 (5) ◽  
pp. 445-452 ◽  
Author(s):  
August F Holtyn ◽  
Forrest Toegel ◽  
Shrinidhi Subramaniam ◽  
Brantley P Jarvis ◽  
Jeannie-Marie Leoutsakos ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Urine Samples ◽  
Control Group ◽  
Opioid Use ◽  
Employment Services ◽  
Employment Specialist ◽  
Drug Abstinence ◽  
Randomised Controlled

BackgroundPoverty, unemployment and substance abuse are inter-related problems. This study evaluated the effectiveness of abstinence-contingent wage supplements in promoting drug abstinence and employment in unemployed adults in outpatient treatment for opioid use disorder.MethodsA randomised controlled trial was conducted in Baltimore, MD, from 2014 to 2019. After a 3-month abstinence initiation and training period, participants (n=91) were randomly assigned to a usual care control group that received employment services or to an abstinence-contingent wage supplement group that received employment services plus abstinence-contingent wage supplements. All participants were invited to work with an employment specialist to seek employment in a community job for 12 months. Abstinence-contingent wage supplement participants could earn training stipends for working with the employment specialist and wage supplements for working in a community job, but had to provide opiate and cocaine-negative urine samples to maximise pay.ResultsAbstinence-contingent wage supplement participants provided significantly more opiate and cocaine-negative urine samples than usual care control participants (65% vs 45%; OR=2.29, 95% CI 1.22 to 4.30, p=0.01) during the 12-month intervention. Abstinence-contingent wage supplement participants were significantly more likely to have obtained employment (59% vs 28%; OR=3.88, 95% CI 1.60 to 9.41, p=0.004) and lived out of poverty (61% vs 30%; OR=3.77, 95% CI 1.57 to 9.04, p=0.004) by the end of the 12-month intervention than usual care control participants.ConclusionAbstinence-contingent wage supplements can promote drug abstinence and employment.Trial registration numberClinicalTrials.gov NCT02487745.

scholarly journals Home-based pulmonary rehabilitation early after hospitalisation in COPD (early HomeBase): protocol for a randomised controlled trial

2021 ◽  
Vol 8 (1) ◽  
pp. e001107
Author(s):  
Narelle S Cox ◽  
Aroub Lahham ◽  
Christine F McDonald ◽  
Ajay Mahal ◽  
Paul O'Halloran ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Hospital Discharge ◽  
Hospital Readmission ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Control Group ◽  
Home Based ◽  
Randomised Controlled

IntroductionChronic obstructive pulmonary disease (COPD) is characterised by exacerbations of respiratory disease, frequently requiring hospital admission. Pulmonary rehabilitation can reduce the likelihood of future hospitalisation, but programme uptake is poor. This study aims to compare hospital readmission rates, clinical outcomes and costs between people with COPD who undertake a home-based programme of pulmonary rehabilitation commenced early (within 2 weeks) of hospital discharge with usual care.MethodsA multisite randomised controlled trial, powered for superiority, will be conducted in Australia. Eligible patients admitted to one of the participating sites for an exacerbation of COPD will be invited to participate. Participants will be randomised 1:1. Intervention group participants will undertake an 8-week programme of home-based pulmonary rehabilitation commencing within 2 weeks of hospital discharge. Control group participants will receive usual care and a weekly phone call for attention control. Outcomes will be measured by a blinded assessor at baseline, after the intervention (week 9–10 posthospital discharge), and at 12 months follow-up. The primary outcome is hospital readmission at 12 months follow-up.Ethics and disseminationHuman Research Ethics approval for all sites provided by Alfred Health (Project 51216). Findings will be published in peer-reviewed journals, conferences and lay publications.Trial registration numberACTRN12619001122145.

scholarly journals Talking about premature ejaculation in primary care: the GET UP cluster randomised controlled trial

BJGP Open ◽  
2021 ◽  
pp. BJGPO.2021.0168
Author(s):  
Marie Barais ◽  
Marine Costa ◽  
Camille Montalvo ◽  
Vincent Rannou ◽  
Hélène Vaillant-Roussel ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Premature Ejaculation ◽  
Controlled Trial ◽  
Communication Strategies ◽  
Training Session ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled

BackgroundPremature ejaculation is the most common sexual dysfunction in men. A previous qualitative study identified six communication strategies described by general practitioners (GP) to tackle this topic during consultations.AimTo determine whether these six strategies are more effective than usual care for promoting discussion about premature ejaculation by patients with their GP.Design and SettingCluster randomised controlled trial, stratified in four French regions, with an intervention group (GPs who received a training session on the six communication strategies) and a control group (routine medical care). Participants were 18-80-year-old men consulting for a sexual, urogenital or psychological reason.MethodThe efficacy of the training session in communication skills, compared with usual care, was evaluated by determining the percentage of patients who discussed premature ejaculation with their GP (primary outcome). The percentage of enrolled patients with premature ejaculation was calculated using as cut-off a score >9 of the Premature Ejaculation Diagnostic Tool filled in by the enrolled patients at week four after the consultation. The quality-of-life changes were evaluated as the SF-12 scale score difference between baseline and week four post-consultation.Results130 patients were included by 32 GPs (n=16 in the intervention and n=16 in the control group). The percentage of patients who discussed about premature ejaculation was higher in the intervention than in the control group (42% vs. 4.9%, absolute difference = 37% 95%CI [24% to 50%], p <0.001).ConclusionsTraining GPs in communication strategies about premature ejaculation improves its detection.ClinicalTrials.govNCT02378779, date of registration: 03/02/2015.

scholarly journals Prospective economic evaluation of an electronic discharge communication tool: analysis of a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e019139 ◽  
Author(s):  
Laura K Sevick ◽  
Maria-Jose Santana ◽  
William A Ghali ◽  
Fiona Clement
Keyword(s):  
Economic Evaluation ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Communication Tool ◽  
Randomised Controlled ◽  
The Cost ◽  
Discharge Communication

ObjectiveTo complete an economic evaluation within a randomised controlled trial (RCT) comparing the use of an electronic discharge communication tool (eDCT) compared with usual care.SettingPatients being discharged from a single tertiary care centre’s internal medicine Medical Teaching Units.ParticipantsBetween January 2012 and December 2013, 1399 patients were randomised to a discharge mechanism. Forty-five patients were excluded from the economic evaluation as they did not have data for the index hospitalisation cost; 1354 patients contributed to the economic evaluation.InterventioneDCT generated at discharge containing structured content on reason for admission, details of the hospital stay, treatments received and follow-up care required. The control group was discharged via traditional dictation methods.Primary and secondary outcome measuresThe primary economic outcome was the cost per quality-adjusted life year (QALY) gained. Secondary outcomes included the cost per death avoided and the cost per readmission avoided.ResultsThe average transcription cost was $C22.28 per patient, whereas the estimated cost of the eDCT was $C13.33 per patient. The cost per QALY gained was $C239 933 in the eDCT arm compared with usual care due to the very small gains in effectiveness and approximately $C800difference in resource utilisation costs. The bootstrap analyses resulted in eDCT being more effective and more costly in 29.2% of samples, less costly and more effective in 29.2% of samples, less effective and more costly in 23.9% of samples and finally, less costly and less effective in 17.7% of samples.ConclusionsThe eDCT reduced per patient costs of the generation of discharge summaries. The bootstrap estimates demonstrate considerable uncertainty supporting the finding of neutrality reported in the clinical component of the RCT. The immediate transcription cost savings and previously documented provider and patient satisfaction may increase the impetus for organisations to invest in such systems, provided they have a foundation of eHealth infrastructure and readiness.Trial registration numberNCT01402609.

scholarly journals Efficacy of electroacupuncture for the treatment of constipation in Parkinson’s disease: study protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e029841
Author(s):  
Kunshan Li ◽  
Zhaoqin Wang ◽  
Yiyi Chen ◽  
Lirong Shen ◽  
Zhongqiu Li ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Control Group ◽  
Bowel Movements ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
Change In Mean

IntroductionConstipation is one of the most common non-motor symptoms in Parkinson’s disease (PD). Acupuncture can have a positive on chronic functional constipation and PD, but its efficacy for the treatment of constipation in PD has not yet been confirmed by high-quality clinical trials. Therefore, this study aims to evaluate the efficacy and safety of electroacupuncture (EA) in the treatment of constipation in PD.Methods and analysisThis study is a multicentre randomised controlled trial. A total of 124 qualified patients with PD and constipation will be randomly divided into the intervention group (62 participants will receive 12 weeks of EA +usual care) or the waitlist control group (62 participants will receive 12 weeks of usual care). EA will be performed three times per week from weeks 1–8, two times per week during weeks 9 and 10, and once a week during weeks 11 and 12. The primary outcome is the change in mean weekly spontaneous bowel movements from baseline to weeks 8 and 9. The secondary outcomes are the changes from baseline in mean weekly bowel movements, mean weekly stool consistency, and mean weekly straining. Other secondary outcomes include the weekly doses of defecation drugs, Visual Analogue Scale for subjective improvements in stool symptoms, Unified Parkinson’s Disease Rating Scale, and the time and number of steps required to walk 20 m. Outcomes will be assessed at baseline, week 4, 8, 12 (intervention period); as well as at week 16, 24 (follow-up period).Ethics and disseminationEthical approval has been obtained from four local ethics committees. The results of the study will be published in peer-reviewed journals and will be disseminated through national and international conferences.Trial registration numberChiCTR1900021053

scholarly journals INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e029185
Author(s):  
Richard Collings ◽  
Jennifer A Freeman ◽  
Jos Latour ◽  
Patricia Jane Vickery ◽  
Sam Glasser ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Diabetic Neuropathy ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Control Group ◽  
Foot Ulceration ◽  
Randomised Controlled

IntroductionFoot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration.AimThis study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.Methods and analysisThis study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention.Ethics and disseminationThe study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications.Trials registration numberISRCTN16011830; Pre-results.

scholarly journals Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
H. Gunn ◽  
K. N. Stevens ◽  
S. Creanor ◽  
J. Andrade ◽  
L. Paul ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Retention Rates ◽  
Clinical Neurology ◽  
Completion Rates ◽  
Definitive Trial ◽  
Randomised Controlled

Abstract Background Balance, mobility impairments and falls are problematic for people with multiple sclerosis (MS). The “Balance Right in MS (BRiMS)” intervention, a 13-week home and group-based exercise and education programme, aims to improve balance and minimise falls. This study aimed to evaluate the feasibility of undertaking a multi-centre randomised controlled trial and to collect the necessary data to design a definitive trial. Methods This randomised controlled feasibility study recruited from four United Kingdom NHS clinical neurology services. Patients ≥ 18 years with secondary progressive MS (Expanded Disability Status Scale 4 to 7) reporting more than two falls in the preceding 6 months were recruited. Participants were block-randomised to either a manualised 13-week education and exercise programme (BRiMS) plus usual care, or usual care alone. Feasibility assessment evaluated recruitment and retention rates, adherence to group assignment and data completeness. Proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls) and economic data were collected at baseline, 13 and 27 weeks, and participants completed daily paper falls diaries. Results Fifty-six participants (mean age 59.7 years, 66% female, median EDSS 6.0) were recruited in 5 months; 30 randomised to the intervention group. Ten (18%) participants withdrew, 7 from the intervention group. Two additional participants were lost to follow up at the final assessment point. Completion rates were > 98% for all outcomes apart from the falls diary (return rate 62%). After adjusting for baseline score, mean intervention—usual care between-group differences for the potential primary outcomes at week 27 were MS Walking Scale-12v2: − 7.7 (95% confidence interval [CI] − 17.2 to 1.8) and MS Impact Scale-29v2: physical 0.6 (CI − 7.8 to 9), psychological − 0.4 (CI − 9.9 to 9). In total, 715 falls were reported, rate ratio (intervention:usual care) for falls 0.81 (0.41 to 2.26) and injurious falls 0.44 (0.41 to 2.23). Conclusions Procedures were practical, and retention, programme engagement and outcome completion rates satisfied a priori progression criteria. Challenges were experienced in completion and return of daily falls diaries. Refinement of methods for reporting falls is therefore required, but we consider a full trial to be feasible. Trial registration ISRCTN13587999 Date of registration: 29 September 2016

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