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 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 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

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 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 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.

scholarly journals Efficacy of a smartphone-based coaching program for addiction prevention among apprentices: study protocol of a cluster-randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Severin Haug ◽  
Raquel Paz Castro ◽  
Andreas Wenger ◽  
Michael P. Schaub
Keyword(s):  
Randomised Controlled Trial ◽  
Cigarette Smoking ◽  
Internet Use ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Addiction Prevention ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background A large proportion of apprentices shows addictive behaviours like cigarette smoking, alcohol, cannabis, or compulsive Internet use, others do not show such behaviours at all. ready4life is a smartphone application-based coaching program for apprentices, which takes into account the heterogeneity of adolescent addictive behaviour by promoting life skills and reducing risk behaviours. The main objective of the planned study is to test the efficacy of ready4life for addiction prevention among apprentices in Switzerland within a controlled trial. Methods/design The efficacy of the ready4life coaching program will be tested in comparison to an assessment only control group, within a cluster-randomised controlled trial with one follow-up assessment after 6 months. At the beginning of the program, participants of the intervention group will receive an individual profile, showing areas in which they have sufficient resources and in which there is a need for coaching. Based on this feedback, they can select two out of the following six program modules: stress, social skills, Internet use, tobacco/e-cigarettes, cannabis, and alcohol. Participants of the intervention group will receive individualised coaching by a conversational agent (chatbot) for a period of four months. The coaching relies on motivational and social-cognitive principles of behaviour change. Within weekly dialogues, the coach provides individually tailored information in different formats, such as videoclips, texts, or pictures. Study participants will be 1318 apprentices with a minimum age of 15, recruited in approximately 100 vocational school classes in Switzerland. Primary outcome will be a composite measure for addictive behaviours including (1) at risk-drinking, (2) tobacco/e-cigarette smoking, (3) cannabis use, and (4) problematic Internet use. Discussion The study will reveal whether this universally implementable but individually tailored intervention approach is effective in preventing the onset and escalation of addictive behaviors among apprentices. Trial registration ISRCTN59908406 (registration date: 21/10/2020).

scholarly journals Assessment of the Effectiveness of a Computerised Decision-Support Tool for Health Professionals for the Prevention and Treatment of Childhood Obesity. Results from a Randomised Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (3) ◽  
pp. 706 ◽  
Author(s):  
George Moschonis ◽  
Maria Michalopoulou ◽  
Konstantina Tsoutsoulopoulou ◽  
Elpis Vlachopapadopoulou ◽  
Stefanos Michalacos ◽  
...  
Keyword(s):  
Decision Support ◽  
Childhood Obesity ◽  
Randomised Controlled Trial ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Intervention Group ◽  
Decision Support Tool ◽  
Control Group ◽  
Support Tool ◽  
Randomised Controlled

We examined the effectiveness of a computerised decision-support tool (DST), designed for paediatric healthcare professionals, as a means to tackle childhood obesity. A randomised controlled trial was conducted with 65 families of 6–12-year old overweight or obese children. Paediatricians, paediatric endocrinologists and a dietitian in two children’s hospitals implemented the intervention. The intervention group (IG) received personalised meal plans and lifestyle optimisation recommendations via the DST, while families in the control group (CG) received general recommendations. After three months of intervention, the IG had a significant change in dietary fibre and sucrose intake by 4.1 and −4.6 g/day, respectively. In addition, the IG significantly reduced consumption of sweets (i.e., chocolates and cakes) and salty snacks (i.e., potato chips) by −0.1 and −0.3 portions/day, respectively. Furthermore, the CG had a significant increase of body weight and waist circumference by 1.4 kg and 2.1 cm, respectively, while Body Mass Index (BMI) decreased only in the IG by −0.4 kg/m2. However, the aforementioned findings did not differ significantly between study groups. In conclusion, these findings indicate the dynamics of the DST in supporting paediatric healthcare professionals to improve the effectiveness of care in modifying obesity-related behaviours. Further research is needed to confirm these findings.

scholarly journals Postcards from the EDge: 5-year outcomes of a randomised controlled trial for hospital-treated self-poisoning

2013 ◽  
Vol 202 (5) ◽  
pp. 372-380 ◽  
Author(s):  
Gregory L. Carter ◽  
Kerrie Clover ◽  
Ian M. Whyte ◽  
Andrew H. Dawson ◽  
Catherine D'Este
Keyword(s):  
Randomised Controlled Trial ◽  
Psychiatric Hospital ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Treatment As Usual ◽  
Psychiatric Admissions ◽  
Bed Days ◽  
Randomised Controlled ◽  
Event Rates

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

Long-term effects on income and sickness benefits after work-focused cognitive-behavioural therapy and individual job support: a pragmatic, multicentre, randomised controlled trial

2018 ◽  
Vol 75 (10) ◽  
pp. 703-708 ◽  
Author(s):  
Simon Øverland ◽  
Astrid Louise Grasdal ◽  
Silje Endresen Reme
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioural Therapy ◽  
Work Participation ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundThere is moderate quality evidence that integrating work-directed interventions and components from psychological therapies reduces sickness absence in the medium term. We aimed to extend this evidence by examining objectively ascertained income and work participation status up to 4 years after an intervention to improve outcomes among people who struggle with work from common mental disorder.MethodsThe intervention combined components from cognitive behavioural therapy with principles from supported employment, and compared its efficacy with usual care. Outcomes were derived from registry data with no attrition, in a pragmatic multisite randomised controlled trial (N=1193).ResultsThe intervention group had higher income, higher work participation and more months without receiving benefits over the 10-month to 46-month long-term follow-up period after end of treatment, but differences were not statistically significant. For the group on long-term benefits at inclusion, effect sizes were larger and statistically significant.ConclusionThere were no statistically significant differences between the two groups in the primary outcome in the total population. In a secondary analysis for the subgroup most at risk of permanent work exclusion, long-term outcomes were favourable in the intervention group compared with usual care. The results support integrated work and health services for people on the severe end of work participation challenges.Trial registration numberNCT01146730.

scholarly journals Effects of a kindergarten intervention on vegetables served and staff’s food-related practices: results of a cluster randomised controlled trial – the BRA study

2020 ◽  
Vol 23 (6) ◽  
pp. 1117-1126
Author(s):  
Anne Himberg-Sundet ◽  
Anne Lene Kristiansen ◽  
Lene Frost Andersen ◽  
Mona Bjelland ◽  
Nanna Lien
Keyword(s):  
Randomised Controlled Trial ◽  
Vegetable Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Public And Private ◽  
Cluster Randomised ◽  
Block Randomisation ◽  
Randomised Controlled

AbstractObjective:The aim of the current study was to evaluate the effect on frequency, variety and amount of vegetables served and staff’s food-related practices in the multicomponent BRA intervention.Design:Cluster randomised controlled trial, conducted between Spring 2015 and Spring 2016. For allocation of the kindergartens, a stratified block randomisation was used. Data were collected in three ways: (i) a questionnaire for pedagogical leaders assessing the variety and frequency of vegetables served, including staff’s food-related practices assumed to be related to vegetable intake; (ii) a questionnaire for kindergarten assistants assessing staff’s food-related practices; (iii) a 5-d weighted vegetable diary assessing amount of vegetables served in a department.Setting:The target group for this study was public and private kindergartens in the counties of Vestfold and Buskerud, Norway.Participants:A total of seventy-three kindergartens participated.Results:At follow-up I, the amount of vegetables served increased by approximately 20 g per person per day (P = 0·002), and the variety in served vegetables increased by one-and-a-half kind per month (P = 0·014) in the intervention group compared to the control group. No effects on the frequency of vegetables served or on staff’s food-related practices were found.Conclusions:The BRA intervention was successful in increasing the amount and variety of vegetables served within intervention kindergartens. Further research is needed to understand the mechanisms that can affect the staff’s food-related practices.

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