scholarly journals Randomised controlled trial of a novel online cognitive rehabilitation programme for children with cerebral palsy: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e028505 ◽  
Author(s):  
Jane Wotherspoon ◽  
Koa Whittingham ◽  
Roslyn N Boyd ◽  
Jeanie Sheffield
Keyword(s):  
Academic Achievement ◽  
Cerebral Palsy ◽  
Executive Function ◽  
Randomised Controlled Trial ◽  
Cognitive Training ◽  
Cognitive Rehabilitation ◽  
Controlled Trial ◽  
Well Being ◽  
Randomised Controlled ◽  
At Home

IntroductionCerebral palsy (CP) is the most common cause of physical disability in children, with an estimated 600–700 infants born with CP in Australia each year. CP is typically associated with motor impairments, but nearly half of all children with CP also experience cognitive impairment, potentially impacting educational and vocational achievement. This paper reports the protocol for a randomised controlled trial of a computerised cognitive training intervention based on behavioural principles: Strengthening Mental Abilities through Relational Training (SMART). The study aims to investigate SMART’s effect on fluid reasoning, executive function and academic achievement in children with CP.Methods and analysisSixty children with mild to moderate CP (Gross Motor Function Classification Scale I–IV) aged between 8 years and 12 years will be recruited. Participants will be randomly allocated to two groups: SMART cognitive training and waitlist control. Families will access the programme at home over a 4-month period. Assessments will be administered at baseline, 20 weeks and at 40 week follow-up for retention. The primary outcome will be fluid intelligence, while academic achievement, executive function and social and emotional well-being will be secondary outcomes.Ethics and disseminationThis study has approval from the Children’s Health Queensland Hospital and Health Service Research Ethics Committee (HREC/14/QRCH/377) and The University of Queensland (2017001806). If the computerised cognitive training programme is found to be effective, dissemination of these findings would assist children with CP by providing an accessible, cost-effective intervention that can be completed at home at the individual’s own pace.Registration detailsThe study was registered prospectively on 10 November 2017 to present. Recruitment is now under way, and we aim to complete recruitment by June 2019, with data collection finalised by March 2020.Trial registration numberACTRN12617001550392; Pre-results.

scholarly journals Randomised controlled trial of Compensatory Cognitive Training and a Computerised Cognitive Remediation programme

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Frances Dark ◽  
Ellie Newman ◽  
Victoria Gore-Jones ◽  
Veronica De Monte ◽  
Marta I. Garrido ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Cognitive Training ◽  
Controlled Trial ◽  
Schizophrenia Spectrum Disorders ◽  
Cognitive Interventions ◽  
Schizophrenia Spectrum ◽  
Spectrum Disorders ◽  
Randomised Controlled

Abstract Background Compensation and adaptation therapies have been developed to improve community functioning via improving neurocognitive abilities in people with schizophrenia. Various modes of delivering compensation and adaptation therapies have been found to be effective. The aim of this trial is to compare two different cognitive interventions, Compensatory Cognitive Training (CCT) and Computerised Interactive Remediation of Cognition–Training for Schizophrenia (CIRCuiTS). The trial also aims to identify if mismatch negativity (MMN) can predict an individual’s response to the compensation and adaptation programmes. Methods This study will use a randomised, controlled trial of two cognitive interventions to compare the impact of these programmes on measures of neurocognition and function. One hundred clinically stable patients aged between 18 and 65 years with a diagnosis of a schizophrenia spectrum disorder will be recruited. Participants will be randomised to either the CCT or the CIRCuiTS therapy groups. The outcome measures are neurocognition (BACS), subjective sense of cognitive impairment (SSTICS), social functioning (SFS), and MMN (measured by EEG) in people with schizophrenia spectrum disorders. Discussion This trial will determine whether different approaches to addressing the cognitive deficits found in schizophrenia spectrum disorders are of comparable benefit using the outcome measures chosen. This has implications for services where cost and lack of computer technology limit the implementation and dissemination of interventions to address cognitive impairment in routine practice. The trial will contribute to the emerging evidence of MMN as a predictor of response to cognitive interventions. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000161224. Registered on 2 February 2018. Protocol version: 4.0, 18 June 2018.

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.

scholarly journals PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; 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.

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