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

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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Recipient and instructor perspectives of an adapted exercise-based fall prevention programme for adults aged 50+ years with vision impairment: a qualitative study nested within a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-038386 ◽

2020 ◽

Vol 10 (9) ◽

pp. e038386

Author(s):

Lisa Dillon ◽

Lindy Clemson ◽

Helen Nguyen ◽

Kirsten Bonrud Jakobsen ◽

Jodi Martin ◽

...

Keyword(s):

Older Adults ◽

Randomised Controlled Trial ◽

Qualitative Study ◽

Fall Prevention ◽

Controlled Trial ◽

Community Dwelling ◽

Vision Impairment ◽

Prevention Programme ◽

Randomised Controlled ◽

Fall Prevention Programme

ObjectiveOlder adults with vision impairment currently have no access to tailored fall prevention programmes. Therefore, the purpose of this study, nested within an ongoing randomised controlled trial (RCT), is to document the adaptation of an existing fall prevention programme and investigate the perspectives of instructors involved in delivery and the older adults with vision impairment receiving the programme (recipients).DesignWe documented programme adaptations and training requirements, and conducted semistructured, individual interviews with both the instructors and the recipients of the programme from 2017 to 2019. The content of each interview was analysed using behaviour change theory through deductive qualitative analysis.SettingNew South Wales and Australian Capital Territory, Australia.ParticipantsThe 11 trained instructors interviewed were employees of a vision rehabilitation organisation and had delivered at least one programme session as part of the RCT. The 154 recipients interviewed were community-dwelling adults aged ≥50 years with vision impairment and no diagnosis of dementia, and had completed their participation in the programme as part of the intervention group of the RCT.ResultsSix key themes were identified relating to recipient (delivery aptitude, social norms, habit formation) and instructor (individualised adaptation, complimentary to scope of practice, challenges to delivery) perspectives. With initial training, instructors required minimal ongoing support to deliver the programme and made dynamic adaptations to suit the individual circumstances of each recipient, but cited challenges delivering the number of programme activities required. Recipient perspectives varied; however, most appreciated the delivery of the programme by instructors who understood the impact of vision impairment.Conclusions and implicationsThis novel qualitative study demonstrates that the adapted programme, delivered by instructors, who already have expertise delivering individualised programmes to older people with vision impairment, may fill the gap for a fall prevention programme in this population.Trial registration numberACTRN12616001186448.

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Enhanced injury prevention programme for recreational runners (the SPRINT study): design of a randomised controlled trial

BMJ Open Sport & Exercise Medicine ◽

10.1136/bmjsem-2020-000780 ◽

2020 ◽

Vol 6 (1) ◽

pp. e000780

Author(s):

Tryntsje Fokkema ◽

Robert-Jan de Vos ◽

Edwin Visser ◽

Patrick Krastman ◽

John IJzerman ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Injury Prevention ◽

Medical Center ◽

Controlled Trial ◽

Intervention Group ◽

Prevention Programme ◽

Control Group ◽

Recreational Runners ◽

Randomised Controlled ◽

Injury Prevention Programme

IntroductionRunning-related injuries (RRIs) are frequent, but no effective injury prevention measures have been identified yet. Therefore, we have set up the INSPIRE trial in 2017, in which the effectiveness of an online injury prevention programme was tested. Although this programme was not effective in reducing the number of RRIs, we gained new insights from this study, which we used to design an enhanced, online multidisciplinary injury prevention programme. The aim of this study is to test the effectiveness of this enhanced injury prevention programme in a group of recreational runners.Methods and analysisFor this randomised controlled trial, we aim to include 3394 recreational runners aged 18 years or older who register for a running event (distances 10 to 42.2 km). During the preparation for the running event, runners in the intervention group get access to the enhanced online injury prevention programme. This online programme consists of 10 steps, all covering separate items of RRI prevention. Runners in the control group will follow their regular preparation. With three follow-up questionnaires (1 month before, 1 week before and 1 month after the running event), the proportions of self-reported RRIs in the intervention group and the control group are compared.Ethics and disseminationAn exemption for a comprehensive application has been obtained by the Medical Ethical Committee of the Erasmus MC University Medical Center, Rotterdam, the Netherlands. The results of the study will be disseminated among the running population, published in peer-reviewed international journals and presented on international conferences.Trial registration numberNL7694

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

BMC Public Health ◽

10.1186/s12889-020-09995-6 ◽

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).

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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 ◽

10.3390/nu11030706 ◽

2019 ◽

Vol 11 (3) ◽

pp. 706 ◽

Cited By ~ 4

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.

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

The British Journal of Psychiatry ◽

10.1192/bjp.bp.112.112664 ◽

2013 ◽

Vol 202 (5) ◽

pp. 372-380 ◽

Cited By ~ 50

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.

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

Public Health Nutrition ◽

10.1017/s1368980019003963 ◽

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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Effectiveness of online tailored advice to prevent running-related injuries and promote preventive behaviour in Dutch trail runners: a pragmatic randomised controlled trial

British Journal of Sports Medicine ◽

10.1136/bjsports-2016-097025 ◽

2017 ◽

Vol 52 (13) ◽

pp. 851-858 ◽

Cited By ~ 13

Author(s):

Luiz Carlos Hespanhol ◽

Willem van Mechelen ◽

Evert Verhagen

Keyword(s):

Randomised Controlled Trial ◽

Preventive Intervention ◽

Absolute Risk ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Number Needed To Treat ◽

Preventive Behaviour ◽

Randomised Controlled ◽

Tailored Advice

BackgroundTrail running is popular worldwide, but there is no preventive intervention for running-related injury (RRI).AimTo evaluate the effectiveness of adding online tailored advice (TrailS6) to general advice on (1) the prevention of RRIs and (2) the determinants and actual preventive behaviour in Dutch trail runners.MethodsTwo-arm randomised controlled trial over 6 months. 232 trail runners were randomly assigned to an intervention or control group. All participants received online general advice on RRI prevention 1 week after baseline. Every 2 weeks, participants in the intervention group received specific advice tailored to their RRI status. The control group received no further intervention. Bayesian mixed models were used to analyse the data.ResultsTrail runners in the intervention group sustained 13% fewer RRIs compared with those in the control group after 6 months of follow-up (absolute risk difference −13.1%, 95% Bayesian highest posterior credible interval (95% BCI) −23.3 to −3.1). A preventive benefit was observed in one out of eight trail runners who had received the online tailored advice for 6 months (number needed to treat 8, 95% BCI 3 to 22). No significant between-group difference was observed on the determinants and actual preventive behaviours.ConclusionsOnline tailored advice prevented RRIs among Dutch trail runners. Therefore, online tailored advice may be used as a preventive component in multicomponent RRI prevention programmes. No effect was observed on determinants and actual preventive behaviours.Trial registration numberThe Netherlands National Trial Register (NTR5431).

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User-driven design of child restraint information to reduce errors in use: a pilot randomised controlled trial

Injury Prevention ◽

10.1136/injuryprev-2019-043380 ◽

2019 ◽

Vol 26 (5) ◽

pp. 432-438 ◽

Cited By ~ 2

Author(s):

Alexandra B Hall ◽

Catherine Ho ◽

Bianca Albanese ◽

Lisa Keay ◽

Kate Hunter ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Instructional Materials ◽

Control Group ◽

P Value ◽

Point Increase ◽

Comprehension Score ◽

Child Restraint ◽

Randomised Controlled

BackgroundIncorrect use of child restraints is a long-standing problem that increases the risk of injury in crashes. We used user-centred design to develop prototype child restraint instructional materials. The objective of this study was to evaluate these materials in terms of comprehension and errors in the use of child restraints. The relationship between comprehension and errors in use was also explored.MethodsWe used a parallel-group randomised controlled trial in a laboratory setting. The intervention group (n=22) were provided with prototype materials and the control group (n=22) with existing instructional materials for the same restraint. Participants installed the restraint in a vehicle buck, secured an appropriately sized mannequin in the restraint and underwent a comprehension test. Our primary outcome was overall correct use, and our secondary outcomes were (1) comprehension score and (2) percent errors in the installation trial.ResultsThere was 27% more overall correct use (p=0.042) and a higher mean comprehension score in the intervention group (mean 17, 95% CI 16 to 18) compared with the control group (mean 12, 95% CI 10 to 14, p<0.001). The mean error percentage in the control group was 23% (95% CI 16% to 31%) compared with 14% in the intervention group (95% CI 8% to 20%, p=0.056). For every one point increase in comprehension, there was an almost 2% (95% CI −2.7% to −1.0%) reduction in errors (y=45.5–1.87x, p value for slope <0.001).ConclusionsConsumer-driven design of informational materials can increase the correct use of child restraints. Targeting improved comprehension of informational materials may be an effective mechanism for reducing child restraint misuse.

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86 Developing the Adapted Lifestyle - Integrated Functional Exercise Programme in Thai Context (TLIFE) to Prevent Falls among Older Adults in Thailand: A Mixed Methods Study

Age and Ageing ◽

10.1093/ageing/afz164.86 ◽

2019 ◽

Vol 48 (Supplement_4) ◽

pp. iv18-iv27

Author(s):

Sasiporn Ounjaichon ◽

Chris Todd ◽

Emma Stanmore ◽

Elisabeth Boulton

Keyword(s):

Older Adults ◽

Randomised Controlled Trial ◽

Retention Rate ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Programme ◽

Community Dwelling ◽

Control Group ◽

Functional Exercise ◽

Randomised Controlled

Abstract Introduction Falls are the leading cause of injuries in older Thai adults. There is a need to develop a fall prevention exercise programme to encourage participation and adherence. The adapted Lifestyle-integrated Functional Exercise (aLiFE) programme may be suitable by integrating exercise into daily routines as opposed to attending an exercise class. This study aimed to explore the acceptability and feasibility of the aLiFE programme in Thai context (TLiFE) among older Thai adults. Methods Based on the findings of a prior qualitative study, a feasibility randomised controlled trial (RCT) of TLiFE was conducted among community-dwelling older adults, comparing the TLiFE intervention group with a usual care control group. Outcome measures were analysed at baseline, 3 months, and after 6 months of the intervention. Results We recruited a total of 72 older adults into the RCT, randomised to TLiFE (n=36) and control (n=36). The retention rate at 6 months was 91.7%. Attendance in the intervention group (3 home visits and 4 follow-up calls) was 82.9%. There were no differences in fall incidence between the groups. The acceptability survey reveals TLiFE is easy to perform in daily life, safe, and useful. No adverse events were reported. Conclusion The TLiFE programme appears to be acceptable and feasible to deliver to community-dwelling older Thai adults. This feasibility study was not powered to detect a difference between groups. A further fully powered definitive randomised controlled trial of TLiFE is needed to evaluate long-term outcomes and cost-effectiveness before it is integrated within the healthcare system in Thailand.

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Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽

10.1136/bmjopen-2018-024589 ◽

2019 ◽

Vol 9 (3) ◽

pp. e024589

Author(s):

Wen Yao Mak ◽

Loke Meng Ong ◽

Bak Leong Goh ◽

Sunita Bavanandan ◽

Lily Mushahar ◽

...

Keyword(s):

Peritoneal Dialysis ◽

Randomised Controlled Trial ◽

Continuous Ambulatory Peritoneal Dialysis ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Open Label ◽

Randomised Controlled ◽

End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

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