scholarly journals Hearing dogs for people with severe and profound hearing loss: a wait-list design randomised controlled trial investigating their effectiveness and cost-effectiveness

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lucy Stuttard ◽  
Philip Boyle ◽  
Caroline Fairhurst ◽  
Catherine Hewitt ◽  
Francesco Longo ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Public Sector ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cost Effective ◽  
Well Being ◽  
The Public ◽  
Hearing Dogs ◽  
Randomised Controlled ◽  
Mental Well Being

Abstract Background Hearing loss increases the risk of poor outcomes across a range of life domains. Where hearing loss is severe or profound, audiological interventions and rehabilitation have limited impact. Hearing dogs offer an alternative, or additional, intervention. They live permanently with recipients, providing sound support and companionship. Methods A single-centre, randomised controlled trial (RCT) evaluated the impacts of a hearing dog on mental well-being, anxiety, depression, problems associated with hearing loss (responding to sounds, fearfulness/social isolation), and perceived dependency on others. Participants were applicants to the UK charity ‘Hearing Dogs for Deaf People’. Eligibility criteria were as follows: first-time applicant; applying for a hearing dog (as opposed to other support provided by the charity). Participants were randomised 1:1 to the following: receive a hearing dog sooner than usual [HD], or within the usual application timeframe (wait-list [WL] comparator). The primary outcome was mental well-being (Short Warwick-Edinburgh Mental Well-Being Scale) 6 months (T1) after HD received a hearing dog. The cost-effectiveness analysis took a health and social care perspective. Results In total, 165 participants were randomised (HD n = 83, WL n = 82). A total of 112 (67.9%) were included in the primary analysis (HD n = 55, WL n = 57). At T1, mental well-being was significantly higher in the HD arm (adjusted mean difference 2.53, 95% CI 1.27 to 3.79, p < 0.001). Significant improvements in anxiety, depression, functioning, fearfulness/social isolation, and perceived dependency, favouring the HD arm, were also observed. On average, HD participants had used fewer statutory health and social care resources. In a scenario whereby costs of provision were borne by the public sector, hearing dogs do not appear to be value for money. If the public sector made a partial contribution, it is possible that hearing dogs would be cost-effective from a public sector perspective. Conclusions Hearing dogs appear to benefit recipients across a number of life domains, at least in the short term. Within the current funding model (costs entirely borne by the charity), hearing dogs are cost-effective from the public sector perspective. Whilst it would not be cost-effective to fully fund the provision of hearing dogs by the public sector, a partial contribution could be explored. Trial registration The trial was retrospectively registered with the International Standard Randomised Controlled Trial Number (ISRCTN) registry on 28.1.2019: ISRCTN36452009.

scholarly journals Early Positive Approaches to Support (E-PAtS) for Families of Young Children With Intellectual Disability: A Feasibility Randomised Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Elinor Coulman ◽  
Nick Gore ◽  
Gwenllian Moody ◽  
Melissa Wright ◽  
Jeremy Segrott ◽  
...  
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Service Provider ◽  
Controlled Trial ◽  
Well Being ◽  
Retention Rates ◽  
Future Trial ◽  
Randomised Controlled ◽  
Mental Well Being ◽  
Post Randomisation

Background: Parents of children with intellectual disabilities are likely to experience poorer mental well-being and face challenges accessing support. Early Positive Approaches to Support (E-PAtS) is a group-based programme, co-produced with parents and professionals, based on existing research evidence and a developmental systems approach to support parental mental well-being. The aim of this study was to assess the feasibility of community service provider organisations delivering E-PAtS to parents/family caregivers of young children with intellectual disability, to inform a potential definitive randomised controlled trial of the effectiveness and cost-effectiveness of E-PAtS.Methods: This study was a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to two parents/family caregivers of a child (18 months to &lt;6 years old) with intellectual disability were recruited at research sites and allocated to intervention (E-PAtS and usual practise) or control (usual practise) on a 1:1 basis at cluster (family) level. Data were collected at baseline and 3 and 12 months' post-randomisation. The following feasibility outcomes were assessed: participant recruitment rates and effectiveness of recruitment pathways; retention rates; intervention adherence and fidelity; service provider recruitment rates and willingness to participate in a future trial; barriers and facilitating factors for recruitment, engagement, and intervention delivery; and feasibility of collecting outcome measures.Results: Seventy-four families were randomised to intervention or control (n = 37). Retention rates were 72% at 12 months post-randomisation, and completion of the proposed primary outcome measure (WEMWBS) was 51%. Recruitment of service provider organisations and facilitators was feasible and intervention implementation acceptable. Adherence to the intervention was 76% and the intervention was well-received by participants; exploratory analyses suggest that adherence and attendance may be associated with improved well-being. Health economic outcome measures were collected successfully and evidence indicates that linkage with routine data would be feasible in a future trial.Conclusions: The E-PAtS Feasibility RCT has demonstrated that the research design and methods of intervention implementation are generally feasible. Consideration of the limitations of this feasibility trial and any barriers to conducting a future definitive trial, do however, need to be considered by researchers.Clinical Trial Registration:https://www.isrctn.com, identifier: ISRCTN70419473.

scholarly journals Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e043478
Author(s):  
Kirsty Sprange ◽  
Gail Mountain ◽  
Claire Craig
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Complex Interventions ◽  
Well Being ◽  
Alternative Methods ◽  
Service Development ◽  
Main Challenge ◽  
Fidelity Assessment ◽  
Randomised Controlled ◽  
Mental Well Being

ObjectivesRobust research of complex interventions designed to promote mental well-being in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a detailed description of the design and implementation of a fidelity assessment within a trial of one such intervention (Lifestyle Matters). The findings help to explain the trial results and also inform the design of embedded fidelity assessments within future evaluations of complex interventions.DesignWe conducted a mixed-method fidelity assessment embedded as part of a multicentre pragmatic randomised controlled trial. A conceptual fidelity framework was developed from the Behaviour Change Consortium framework. From this the fidelity assessment was designed. The resulting instrument assessed the following parameters: intervention design, training, supervision; and delivery, receipt and enactment of the intervention.InterventionThe Lifestyle Matters intervention was designed to assist older people to improve and sustain mental well-being through participation in meaningful activity. The aim is to enable participants to engage in both new and neglected activities through a mix of facilitated group meetings and individual sessions.ResultsThe fidelity assessment demonstrated that the intervention was delivered as per protocol for the group component and was tailored to meet individual needs. There was substantial inter-rater agreement for training; and group member performance 0.72; and moderate agreement for facilitator performance 0.55. It was not possible to determine whether small declines seen in facilitator performance were due to facilitator drift or moderating factors such as group dynamics or participant characteristics.ConclusionsThe assessment methods adequately measured criteria identified as being significant indicators of fidelity. Adherence during training, delivery and supervision was good. The subjective nature of identification and rating observed behaviours was the main challenge. Future research should explore alternative methods of assessing fidelity in trials of complex interventions.Trial registration numberISRCTN67209155.

scholarly journals Study design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: a cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042850
Author(s):  
Karin Leder ◽  
John J Openshaw ◽  
Pascale Allotey ◽  
Ansariadi Ansariadi ◽  
S Fiona Barker ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Human Health ◽  
Controlled Trial ◽  
Informal Settlements ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Cluster Randomised ◽  
Abundance And Diversity ◽  
Randomised Controlled ◽  
Health And Well Being

IntroductionIncreasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysisRISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.EthicsStudy protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration numberACTRN12618000633280; Pre-results.

A randomised controlled trial to test a non-metallic deodorant used during a course of radiotherapy

2000 ◽  
Vol 1 (4) ◽  
pp. 205-212 ◽  
Author(s):  
A. Gee ◽  
D. Moffitt ◽  
M. Churn ◽  
R.D. Errington
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Psychological Benefits ◽  
Weekly Basis ◽  
Skin Reactions ◽  
Treated Area ◽  
The Past ◽  
Randomised Controlled ◽  
Larger Sample

Background: Radiotherapy skin reactions have been well documented in the past. Until recently, washing of the treated area and the use of perfumed products that contain metals has not been advocated during treatment. The aims of this study were to assess the skin reactions of patients using a non-metallic deodorant and to see whether there were any psychological benefits from being able to use the deodorant.Method: 41 women attending for radiotherapy to either the breast or breast and axilla were recruited into the trial. They were randomised into one of two groups. Complete data was obtained for 36 patients. 20 patients used the deodorant and 16 did not. Any skin reactions noted were recorded on a weekly basis. Patients were also asked to complete a questionnaire relating to feelings and activities and to comment on the deodorant if they had used it.Results: Skin reactions did seem to be slightly worse in the patients using deodorant, and it was only in this group of patients that axillary reactions were noted. However, neither of these results were statistically significant. The use of the deodorant did not have any impact on the psychological well being of the patients, but patients using it had found it pleasant to use and the majority said that they would use it again.Conclusion: Further study is indicated to look at skin reactions using the deodorant with a larger sample of patients.

scholarly journals Cost-effectiveness of habit-based advice for weight control versus usual care in general practice in the Ten Top Tips (10TT) trial: economic evaluation based on a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e017511 ◽  
Author(s):  
Nishma Patel ◽  
Rebecca J Beeken ◽  
Baptiste Leurent ◽  
Rumana Z Omar ◽  
Irwin Nazareth ◽  
...  
Keyword(s):  
General Practice ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Health Service ◽  
Usual Care ◽  
Controlled Trial ◽  
Cost Effective ◽  
The Mean ◽  
Randomised Controlled

ObjectiveTen Top Tips (10TT) is a primary care-led behavioural intervention which aims to help adults reduce and manage their weight by following 10 weight loss tips. The intervention promotes habit formation to encourage long-term behavioural changes. The aim of this study was to estimate the cost-effectiveness of 10TT in general practice from the perspective of the UK National Health Service.DesignAn economic evaluation was conducted alongside an individually randomised controlled trial.Setting14 general practitioner practices in England.ParticipantsAll patients were aged ≥18 years, with body mass index ≥30 kg/m2. A total of 537 patients were recruited; 270 received the usual care offered by their practices and 267 received the 10TT intervention.Outcomes measuresHealth service use and quality-adjusted life years (QALYs) were measured over 2 years. Analysis was conducted in terms of incremental net monetary benefits (NMBs), using non-parametric bootstrapping and multiple imputation.ResultsOver a 2-year time horizon, the mean costs and QALYs per patient in the 10TT group were £1889 (95% CI £1522 to £2566) and 1.51 (95% CI 1.44 to 1.58). The mean costs and QALYs for usual care were £1925 (95% CI £1599 to £2251) and 1.51 (95% CI 1.45 to 1.57), respectively. This generated a mean cost difference of −£36 (95% CI −£512 to £441) and a mean QALY difference of 0.001 (95% CI −0.080 to 0.082). The incremental NMB for 10TT versus usual care was £49 (95% CI −£1709 to £1800) at a maximum willingness to pay for a QALY of £20 000. 10TT had a 52% probability of being cost-effective at this threshold.ConclusionsCosts and QALYs for 10TT were not significantly different from usual care and therefore 10TT is as cost-effective as usual care. There was no evidence to recommend nor advice against offering 10TT to obese patients in general practices based on cost-effectiveness considerations.Trial registration numberISRCTN16347068; Post-results.

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