scholarly journals A self-management programme to reduce falls and improve safe mobility in people with secondary progressive MS: the BRiMS feasibility RCT

2019 ◽  
Vol 23 (27) ◽  
pp. 1-166 ◽  
Author(s):  
Hilary Gunn ◽  
Jackie Andrade ◽  
Lorna Paul ◽  
Linda Miller ◽  
Siobhan Creanor ◽  
...  
Keyword(s):  
Usual Care ◽  
Intervention Group ◽  
Health Technology ◽  
Feasibility Trial ◽  
Completion Rates ◽  
Economic Data ◽  
Definitive Trial ◽  
Secondary Progressive ◽  
Edss Score ◽  
Randomised Controlled

Background Balance, mobility impairments and falls are common problems for people with multiple sclerosis (MS). Our ongoing research has led to the development of Balance Right in MS (BRiMS), a 13-week home- and group-based exercise and education programme intended to improve balance and encourage safer mobility. Objective This feasibility trial aimed to obtain the necessary data and operational experience to finalise the planning of a future definitive multicentre randomised controlled trial. Design Randomised controlled feasibility trial. Participants were block randomised 1 : 1. Researcher-blinded assessments were scheduled at baseline and at 15 and 27 weeks post randomisation. As is appropriate in a feasibility trial, statistical analyses were descriptive rather than involving formal/inferential comparisons. The qualitative elements utilised template analysis as the chosen analytical framework. Setting Four sites across the UK. Participants Eligibility criteria included having a diagnosis of secondary progressive MS, an Expanded Disability Status Scale (EDSS) score of between ≥ 4.0 and ≤ 7.0 points and a self-report of two or more falls in the preceding 6 months. Interventions Intervention – manualised 13-week education and exercise programme (BRiMS) plus usual care. Comparator – usual care alone. Main outcome measures Trial feasibility, proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls), feasibility of the BRiMS programme (via process evaluation) and economic data. Results A total of 56 participants (mean age 59.7 years, standard deviation 9.7 years; 66% female; median EDSS score of 6.0 points, interquartile range 6.0–6.5 points) were recruited in 5 months; 30 were block randomised to the intervention group. The demographic and clinical data were broadly comparable at baseline; however, the intervention group scored worse on the majority of baseline outcome measures. Eleven participants (19.6%) withdrew or were lost to follow-up. Worsening of MS-related symptoms unrelated to the trial was the most common reason (n = 5) for withdrawal. Potential primary and secondary outcomes and economic data had completion rates of > 98% for all those assessed. However, the overall return rate for the patient-reported falls diary was 62%. After adjusting for baseline score, the differences between the groups (intervention compared with usual care) at week 27 for the potential primary outcomes were MS Walking Scale (12-item) version 2 –7.7 [95% confidence interval (CI) –17.2 to 1.8], MS Impact Scale (29-item) version 2 (MSIS-29vs2) physical 0.6 (95% CI –7.8 to 9) and MSIS-29vs2 psychological –0.4 (95% CI –9.9 to 9) (negative score indicates improvement). After the removal of one outlier, a total of 715 falls were self-reported over the 27-week trial period, with substantial variation between individuals (range 0–93 falls). Of these 715 falls, 101 (14%) were reported as injurious. Qualitative feedback indicated that trial processes and participant burden were acceptable, and participants highlighted physical and behavioural changes that they perceived to result from undertaking BRiMS. Engagement varied, influenced by a range of condition- and context-related factors. Suggestions to improve the utility and accessibility of BRiMS were highlighted. Conclusions The results suggest that the trial procedures are feasible and acceptable, and retention, programme engagement and outcome completion rates were sufficient to satisfy the a priori progression criteria. Challenges were experienced in some areas of data collection, such as completion of daily diaries. Future work Further development of BRiMS is required to address logistical issues and enhance user-satisfaction and adherence. Following this, a definitive trial to assess the clinical effectiveness and cost-effectiveness of the BRiMS intervention is warranted. Trial registration Current Controlled Trials ISRCTN13587999. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 27. See the NIHR Journals Library website for further project information.

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 Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial

2017 ◽  
Vol 21 (34) ◽  
pp. 1-92 ◽  
Author(s):  
William Jeffcoate ◽  
Frances Game ◽  
Vivienne Turtle-Savage ◽  
Alison Musgrove ◽  
Patricia Price ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Usual Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Health Technology ◽  
Control Group ◽  
Advisory Panel ◽  
Health Economic Analysis ◽  
Randomised Controlled

Background Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel. Objective To assess both the clinical effectiveness and the cost-effectiveness of lightweight fibreglass casts in the management of heel ulcers. Design A pragmatic, multicentre, parallel, observer-blinded randomised controlled trial. A central randomisation centre used a computer-generated random number sequence to allocate participants to groups. Setting Thirty-five specialist diabetic foot secondary care centres in the UK. Those recruited were aged ≥ 18 years and had diabetes mellitus complicated by ulcers of the heel of grades 2–4 on the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel scale. Participants In total, 509 participants [68% male, 15% with type 1 diabetes mellitus, mean age 67.5 years (standard deviation 12.4 years)] were randomised 1 : 1 to the intervention (n = 256) or the control (n = 253) arm. The primary outcome data were available for 425 participants (212 from the intervention arm and 213 from the control arm) and exceeded the total required; attrition was 16.5%. The median ulcer area at baseline was 275 mm2 [interquartile range (IQR) 104–683 mm2] in the intervention group and 206 mm2 (IQR 77–649 mm2) in the control group. There were no differences between the two groups at baseline in any parameter, neither in relation to the participant nor in relation to their ulcer. Interventions The intervention group received usual care supplemented by the addition of an individually moulded, lightweight, fibreglass heel cast. The control group received usual care alone. The intervention phase continued either until the participant’s ulcer had healed (maintained for 28 days) or for 24 weeks, whichever occurred first. During this intervention phase, the participants were reviewed every 2 weeks, and the fibreglass casts were replaced when they were no longer usable. Main outcome measures The primary outcome measure was ulcer healing (confirmed by a blinded observer and maintained for 4 weeks) within 24 weeks. Other outcome measures included the time taken for the ulcer to heal, the percentage reduction in the cross-sectional area, the reduction in local pain, amputation, survival and health economic analysis. The study was powered to define a difference in healing of 15% (55% intervention vs. 40% control). Results Forty-four per cent (n = 94) of the intervention group healed within 24 weeks, compared with 37% (n = 80) of the control participants (odds ratio 1.42, 95% confidence interval 0.95 to 2.14; p = 0.088), using an intention-to-treat analysis. No differences were observed between the two groups for any secondary outcome. Limitations Although the component items of care were standardised, because this was a pragmatic trial, usual care was not uniform. There was some evidence of a small excess of adverse events in the intervention group; however, non-blinded observers documented these events. There was no excess of adverse device effects. Conclusions There may be a small increase in healing with the use of a heel cast, but the estimate was not sufficiently precise to provide strong evidence of an effect. There was no evidence of any subgroup in which the intervention appeared to be particularly effective. A health economic analysis suggested that it is unlikely that the intervention represents good value for money. The provision of a lightweight heel cast may be of benefit to some individuals, but we have found no evidence to justify the routine adoption of this in clinical practice. Future work It is unlikely that further study of this intervention will have an impact on usual clinical care, and so future efforts should be directed towards other interventions designed to improve the healing of ulcers in this population. Trial registration Current Controlled Trials ISRCTN62524796. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 34. See the NIHR Journals Library website for further project information.

scholarly journals Preventing blood-borne virus infection in people who inject drugs in the UK: systematic review, stakeholder interviews, psychosocial intervention development and feasibility randomised controlled trial

2017 ◽  
Vol 21 (72) ◽  
pp. 1-312 ◽  
Author(s):  
Gail Gilchrist ◽  
Davina Swan ◽  
April Shaw ◽  
Ada Keding ◽  
Sarah Towers ◽  
...  
Keyword(s):  
People Who Inject Drugs ◽  
Controlled Trial ◽  
Intervention Group ◽  
Health Technology ◽  
Feasibility Trial ◽  
Control Group ◽  
Risk Behaviours ◽  
Post Intervention ◽  
Information Booklet ◽  
Randomised Controlled

Background Opioid substitution therapy and needle exchanges have reduced blood-borne viruses (BBVs) among people who inject drugs (PWID). Some PWID continue to share injecting equipment. Objectives To develop an evidence-based psychosocial intervention to reduce BBV risk behaviours and increase transmission knowledge among PWID, and conduct a feasibility trial among PWID comparing the intervention with a control. Design A pragmatic, two-armed randomised controlled, open feasibility trial. Service users were Steering Group members and co-developed the intervention. Peer educators co-delivered the intervention in London. Setting NHS or third-sector drug treatment or needle exchanges in Glasgow, London, Wrexham and York, recruiting January and February 2016. Participants Current PWID, aged ≥ 18 years. Interventions A remote, web-based computer randomisation system allocated participants to a three-session, manualised, psychosocial, gender-specific group intervention delivered by trained facilitators and BBV transmission information booklet plus treatment as usual (TAU) (intervention), or information booklet plus TAU (control). Main outcome measures Recruitment, retention and follow-up rates measured feasibility. Feedback questionnaires, focus groups with participants who attended at least one intervention session and facilitators assessed the intervention’s acceptability. Results A systematic review of what works to reduce BBV risk behaviours among PWID; in-depth interviews with PWID; and stakeholder and expert consultation informed the intervention. Sessions covered improving injecting technique and good vein care; planning for risky situations; and understanding BBV transmission. Fifty-six per cent (99/176) of eligible PWID were randomised: 52 to the intervention group and 47 to the control group. Only 24% (8/34) of male and 11% (2/18) of female participants attended all three intervention sessions. Overall, 50% (17/34) of men and 33% (6/18) of women randomised to the intervention group and 47% (14/30) of men and 53% (9/17) of women randomised to the control group were followed up 1 month post intervention. Variations were reported by location. The intervention was acceptable to both participants and facilitators. At 1 month post intervention, no increase in injecting in ‘risky’ sites (e.g. groin, neck) was reported by participants who attended at least one session. PWID who attended at least one session showed a trend towards greater reduction in injecting risk behaviours, a greater increase in withdrawal planning and were more confident about finding a vein. A mean cost of £58.17 per participant was calculated for those attending one session, £148.54 for those attending two sessions and £270.67 for those attending all three sessions, compared with £0.86 in the control group. Treatment costs across the centres vary as a result of the different levels of attendance, as total session costs are divided by attendees to obtain a cost per attendee. The economic analysis suggests that a cost-effectiveness study would be feasible given the response rates and completeness of data. However, we have identified aspects where the service use questionnaire could be abbreviated given the low numbers reported in several care domains. No adverse events were reported. Conclusions As only 19% of participants attended all three intervention sessions and 47% were followed up 1 month post intervention, a future definitive randomised controlled trial of the intervention is not feasible. Exposure to information on improving injecting techniques did not encourage riskier injecting practices or injecting frequency, and benefits were reported among attendees. The intervention has the potential to positively influence BBV prevention. Harm reduction services should ensure that the intervention content is routinely delivered to PWID to improve vein care and prevent BBVs. Future work The intervention did not meet the complex needs of some PWID, more tailoring may be needed to reach PWID who are more frequent injectors, who are homeless and female. Limitations Intervention delivery proved more feasible in London than other locations. Non-attendance at the York trial site substantially influenced the results. Trial registration Current Controlled Trials ISRCTN66453696 and PROSPERO 014:CRD42014012969. Funding This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 72. See the NIHR Journals Library website for further project information.

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 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 Randomised controlled feasibility trial of an active communication education programme plus hearing aid provision versus hearing aid provision alone (ACE To HEAR)

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e043364
Author(s):  
Judith Watson ◽  
Elizabeth Coleman ◽  
Cath Jackson ◽  
Kerry Bell ◽  
Christina Maynard ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Hearing Aids ◽  
Hearing Aid ◽  
Intervention Group ◽  
Feasibility Trial ◽  
Control Group ◽  
Communication Education ◽  
Treatment As Usual ◽  
Active Communication ◽  
Randomised Controlled

ObjectiveTo establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality of life through improving communication and hearing aid use in the UK National Health Service.DesignRandomised controlled, open feasibility trial with embedded economic and process evaluations.SettingAudiology departments in two hospitals in two UK cities.ParticipantsTwelve hearing aid users aged 18 years or over who reported moderate or less than moderate benefit from their new hearing aid.InterventionsConsenting participants (along with a significant other) were to be randomised by a remote, centralised randomisation service in groups to ACE plus treatment-as-usual (intervention group) or treatment-as-usual only (control group).Primary outcome measuresThe primary outcomes were related to feasibility: recruitment, retention, treatment adherence and acceptability to participants and fidelity of treatment delivery.Secondary outcome measuresInternational Outcomes Inventory for Hearing Aids, Self-Assessment of Communication, EQ-5D-5L and Short-Form 36. Blinding of the participants and facilitator was not possible.ResultsTwelve hearing aid users and six significant others consented to take part. Eight hearing aid users were randomised: four to the intervention group; and four to treatment-as-usual only. Four significant others participated alongside the randomised participants. Recruitment to the study was very low and centres only screened 466 hearing aid users over the 15-month recruitment period, compared with the approximately 3500 anticipated. Only one ACE group and one control group were formed. ACE could be delivered and appeared acceptable to participants. We were unable to robustly assess attrition and attendance rates due to the low sample size.ConclusionsWhile ACE appeared acceptable to hearing aid users and feasible to deliver, it was not feasible to identify and recruit participants struggling with their hearing aids at the 3-month posthearing aid fitting point.Trial registration numberISRCTN28090877.

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 Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)

2017 ◽  
Vol 21 (24) ◽  
pp. 1-198 ◽  
Author(s):  
Sarah Cockayne ◽  
Sara Rodgers ◽  
Lorraine Green ◽  
Caroline Fairhurst ◽  
Joy Adamson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Incidence Rate ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Falls Prevention ◽  
Randomised Controlled

BackgroundFalls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DesignA pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SettingNine NHS trusts in the UK and one site in Ireland.ParticipantsIn total, 1010 participants aged ≥ 65 years were randomised (intervention,n = 493; usual care,n = 517) via a secure, remote service. Blinding was not possible.InterventionsAll participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.Main outcome measuresThe primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.ResultsThe primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05;p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00;p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LimitationsOwing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.ConclusionsThe intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.Future workFurther research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.Trial registrationCurrent Controlled Trials ISRCTN68240461.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.

scholarly journals Longer-term health and social care strategies for stroke survivors and their carers: the LoTS2Care research programme including cluster feasibility RCT

2021 ◽  
Vol 9 (3) ◽  
pp. 1-268
Author(s):  
Anne Forster ◽  
Seline Ozer ◽  
Thomas F Crocker ◽  
Allan House ◽  
Jenny Hewison ◽  
...  
Keyword(s):  
Usual Care ◽  
Unmet Needs ◽  
Social Care ◽  
Feasibility Trial ◽  
Stroke Survivors ◽  
Post Stroke ◽  
Cluster Randomised ◽  
Health And Social Care ◽  
Stroke Services ◽  
Randomised Controlled

Background It is reported that the longer-term outcomes for stroke survivors are poor, with a range of unmet needs identified. Objectives The aims were to develop and test a longer-term stroke care strategy focused on improving the quality of life of stroke survivors and their carers by addressing unmet needs, and maintenance and enhancement of participation (i.e. involvement in life situations). Design Five overlapping workstreams were undertaken – (1) refinement of content by semistructured interviews with stroke survivors and their carers and by a review of the literature to inform content and delivery of the care strategy; (2) exploration of service models by national survey and focus groups with purposely selected services; (3) intervention development by interaction with a reference group of stroke survivors, carers, and health and social care professionals; (4) refinement and pilot implementation of the developed intervention in three stroke services (case studies); and (5) a cluster randomised controlled feasibility trial in 10 stroke services across England and Wales. Setting The intervention development work and feasibility trial were in stroke services (inclusive of primary, secondary, community and social care provision) across England and Wales. Participants Participants were stroke survivors resident in the community and their carers, and health and social care professionals in the included stroke services. Data sources Interviews with 28 stroke survivors and their carers at least 9 months post stroke ascertained their needs and the barriers to and facilitators of addressing those needs. Additional literature reviews identified 23 needs. No evidence-based interventions to address these needs were reported; self-management was highlighted as a possible delivery mechanism. In workstream 2, a national survey revealed that the most common model of stroke service provision was care up to 12 months post stroke, reported by 46 (40%) services. Thirty-five (30%) services provided care up to 6 months post stroke and 35 (30%) provided care beyond 12 months, thus identifying 6 months post stroke as an appropriate delivery point for a new intervention. Through focus groups in a range of services, stroke survivors’ perceived unmet needs and the barriers to and enablers of service provision were identified. Intervention Using information obtained in workstreams 1 and 2 and working closely with a stakeholder reference group, we developed an intervention based on the unmet needs prioritised by stroke survivors and their carers (workstream 3). In workstream 4, action groups (clinicians, stroke survivors and researchers) were established in three stroke services that led implementation in their service and contributed to the iterative refinement of the intervention, associated training programme and implementation materials. The intervention (called New Start) was delivered at 6 months post stroke. Key components were problem-solving self-management with survivors and carers, help with obtaining usable information, and helping survivors and their carers build sustainable, flexible support networks. Results A cluster randomised feasibility trial (workstream 5) was successfully implemented in 10 stroke services across England and Wales, with associated process and health economic evaluations. Five services were randomised to provide New Start, while five continued with usual care; 269 participants were recruited. Progression criteria – in terms of our pre-determined (red, amber, green) criteria for progress to a full trial: target stroke survivor recruitment rates were achieved, on average, across sites (24.1 per site over 6 months, green); 216 (80.3%) registered stroke survivors returned follow-up questionnaires at 9 months (84.1% in the intervention arm and 75.8% in the usual care arm, green); according to data reported by sites, overall, 95.2% of registered stroke survivors were offered at least one session of the intervention (green); all five intervention sites had at least two facilitators deemed competent, delivered the New Start intervention and provided it to stroke survivors (green). However, at some sites, there were concerns regarding the number of stroke survivors being offered, accepting and receiving the intervention. Only small differences in outcomes and costs were observed between the New Start and usual care groups, and considerable uncertainty around the cost-effectiveness remains. Conclusions We report a complex programme of work that has described the longer-term needs of stroke survivors and highlighted evidence and service gaps. Working closely with stroke survivors, an intervention was developed that has been refined in three services and feasibility tested in a cluster randomised controlled trial. Further refinement of the target population and optimisation of the intervention materials is required prior to a full randomised controlled trial evaluation. Future work Optimisation of the intervention, and clearer specification of recipients, are required prior to a full trial evaluation. Trial registration Current Controlled Trials ISRCTN38920246. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 3. See the NIHR Journals Library website for further project information.

scholarly journals A Proactive Telephone-Delivered Risk Communication Intervention for Smokers Participating in Lung Cancer Screening: A Pilot Feasibility Trial

2017 ◽  
Vol 13 (3) ◽  
pp. 137-144 ◽  
Author(s):  
Steven B. Zeliadt ◽  
Preston A. Greene ◽  
Paul Krebs ◽  
Deborah E. Klein ◽  
Laura C. Feemster ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Cancer Screening ◽  
Usual Care ◽  
Usual Care Group ◽  
Intervention Group ◽  
Lung Cancer Screening ◽  
Feasibility Trial ◽  
Care Group ◽  
Telephone Counselling ◽  
Tobacco Treatment

Introduction: Many barriers exist to integrating smoking cessation into delivery of lung cancer screening including limited provider time and patient misconceptions.Aims: To demonstrate that proactive outreach from a telephone counsellor outside of the patient's usual care team is feasible and acceptable to patients.Methods: Smokers undergoing lung cancer screening were approached for a telephone counselling study. Patients agreeing to participate in the intervention (n = 27) received two telephone counselling sessions. A 30-day follow-up evaluation was conducted, which also included screening participants receiving usual care (n = 56).Results/Findings: Most (89%) intervention participants reported being satisfied with the proactive calls, and 81% reported the sessions were helpful. Use of behavioural cessation support programs in the intervention group was four times higher (44%) compared to the usual care group (11%); Relative Risk (RR) = 4.1; 95% CI: 1.7 to 9.9), and seven-day abstinence in the intervention group was double (19%) compared to the usual care group (7%); RR = 2.6; 95% CI: 0.8 to 8.9).Conclusions: This practical telephone-based approach, which included risk messages clarifying continued risks of smoking in the context of screening results, suggests such messaging can boost utilisation of evidence-based tobacco treatment, self-efficacy, and potentially increase the likelihood of successful quitting.

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