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1.
Trials ; 23(1): 905, 2022 Oct 27.
Article in English | MEDLINE | ID: covidwho-2089230

ABSTRACT

BACKGROUND: Participant recruitment into clinical trials remains challenging. The global increase in the number of social media users has accelerated the use of social media as a modality of recruitment, particularly during the COVID-19 pandemic when traditional recruitment methods were reduced. However, there is limited evidence on the performance of social media recruitment strategies into eczema clinical trials. METHODS: From September 2021 to January 2022, we recruited participants with eczema into an online randomised controlled trial using free advertising on Twitter, Facebook, Instagram and Reddit (unpaid methods), followed by paid Facebook advertisements (paid method). Unpaid methods were used periodically for 63 days, whilst the paid method for 16 days. Interested individuals who clicked on the advertisement link were directed to the study website, where they could sign up to participate. Consenting, randomisation and data collection occurred exclusively online, using a database management web platform. Evaluation of the social media recruitment methods was performed, including the number of expression of interests, enrolment yield, cost, baseline characteristics and retention. RESULTS: Our multi-platform based social media recruitment strategy resulted in 400 expressions of interests, leading to 296 participants. Unpaid methods accounted for 136 (45.9%) of participants, incurring no financial cost. Paid Facebook adverts reached 154,370 individuals, resulting in 123 (41.6%) trial participants for a total cost of £259.93 (£2.11 per participant) and other recruitment methods resulted in 37 (12.5%) enrolments. Paid advertisements predominantly attracted younger participants below the age of 20, whereas unpaid methods mainly drew in participants between 20-29 years of age. The social media platforms recruited an ethnically diverse participant population. Completion rate of follow-up was slightly higher for the paid method (n = 103, 83.7%) compared with the unpaid methods (n = 111, 81.6%). CONCLUSIONS: Unpaid social media posts recruited the most participants; however, it was time consuming for the researcher. Paid Facebook adverts rapidly recruited a large number of participants for a low cost and provided flexibility to target specific audiences. Our findings indicate that social media is an efficient tool that can potentially support recruitment to clinical trials. TRIAL REGISTRATION: ISRCTN45167024. Registered on 29 June 2021.


Subject(s)
COVID-19 , Eczema , Social Media , Adult , Humans , Young Adult , Advertising/methods , Pandemics
2.
The Lancet Regional Health - Southeast Asia ; JOUR: 100086,
Article in English | ScienceDirect | ID: covidwho-2083135

ABSTRACT

Summary Background Sedentary behaviour increases the risks of non-communicable diseases. The objective of this trial was to evaluate the effect of the Physical Activity at Work multicomponent intervention to reduce sedentary behaviour in Thai office workers. Methods Offices under the Ministry of Public Health Thailand, were randomly allocated to the intervention and control group in a 1:1 ratio, stratified by office size. The intervention included individual (pedometer and lottery-based financial incentives), social (group movement breaks), environmental (posters), and organisational (leader encouragement) components. At baseline and 6-month follow-up, participants wore ActiGraphTM on the waist for ten days. The primary outcome was the between-group difference in sedentary time at 6-month, analysed using a linear mixed-effects model. Other outcomes were physical activity, biomarkers, productivity, and musculoskeletal health. Trial registration: The PAW study was registered at the Thai Clinical Trials Registry (ID TCTR20200604007) on 02 June 2020. Findings 282 office workers were recruited and randomly allocated to the control group (142 participants, nine offices) and the intervention group (140 participants, nine offices). The mean age was 38.6 years (SD = 10.4), and 81% were women. There was no evidence of intervention effects on sedentary time during waking hours (−26.8;95% CI = −69.2 to 15.7 min), physical activity levels, or biomarkers between groups at 6-month. In the adjusted analysis, increases in time spent in moderate-to-vigorous physical activity (5.45;95% CI = −0.15 to 11.1 min) and step count (718;95% CI = −45 to 1481 steps) during waking hours were observed, although there was no evidence of a difference between groups. Interpretation The intervention did not significantly reduce sedentary time in Thai office workers. Suboptimal intervention uptake due to Covid-19 pandemic restrictions and loss of statistical power associated with recruitment constraints may explain this result. Further investigations are needed to evaluate the processes of the trial. Funding The Thai Health Promotion Foundation and the International Decision Support Initiative (iDSI).

3.
J Appl Res Intellect Disabil ; 2022 Oct 12.
Article in English | MEDLINE | ID: covidwho-2063775

ABSTRACT

BACKGROUND: Aggressive incidents are common in people with intellectual disabilities. Therefore, we aimed to assess whether supplementation of multivitamins, minerals, and omega-3 fatty acids (FA) reduces aggressive incidents. METHODS: We conducted a randomised, triple blind, placebo controlled, single crossover intervention trial. People with intellectual disabilities or borderline intellectual functioning, between 12 and 40 years of age, and showing aggressive behaviour were included. Participants received either a daily dose of dietary supplements, or placebo. Primary outcome was the number of aggressive incidents, measured using the Modified Overt Aggression Scale (MOAS). RESULTS: there were 113 participants (placebo, n = 56), of whom 24 (placebo, n = 10) participated in the crossover phase of the trial. All 137 trajectories were included in the analyses. There was no significant difference in mean number of aggressive incidents per day between those assigned to supplements and those who received placebo (rate ratio = 0.93: 95% Confidence Interval [CI] = 0.59-1.45). CONCLUSION: In this pragmatic trial, we did not find significant differences in the outcomes between the supplement and placebo arms. The COVID-19 pandemic started midway through our trial, this may have affected the results.

4.
Pilot Feasibility Stud ; 8(1): 222, 2022 Oct 01.
Article in English | MEDLINE | ID: covidwho-2053985

ABSTRACT

BACKGROUND: The 'Your Care Needs You' (YCNY) intervention aims to increase the safety and experience of transitions for older people through greater patient involvement during the hospital stay. METHODS: A cluster randomised controlled feasibility trial was conducted on NHS inpatient wards (clusters) where ≥ 40% of patients were routinely ≥ 75 years. Wards were randomised to YCNY or usual care using an unequal allocation ratio (3:2). We aimed to recruit up to 20 patients per ward. Follow-up included routine data collection and questionnaires at 5-, 30-, and 90-days post-discharge. Eligible patients were ≥ 75 years, discharged home, stayed overnight on participating wards, and could read and understand English. The trial assessed the feasibility of delivering YCNY and the trial methodology through recruitment rates, outcome completion rates, and a qualitative evaluation. The accuracy of using routinely coded data for the primary outcome in the definitive trial was assessed by extracting discharge information for up to ten nonindividual consenting patients per ward. RESULTS: Ten wards were randomised (6 intervention, 4 control). One ward withdrew, and two wards were unable to deliver the intervention. Seven-hundred twenty-one patients were successfully screened, and 161 were recruited (95 intervention, 66 control). The patient post-discharge attrition rate was 17.4% (n = 28). Primary outcome data were gathered for 91.9% of participants with 75.2% and 59.0% providing secondary outcome data at 5 and 30 days post-discharge respectively. Item completion within questionnaires was generally high. Post-discharge follow-up was terminated early due to the COVID-19 pandemic affecting 90-day response rates (16.8%). Data from 88 nonindividual consenting patients identified an error rate of 15% when using routinely coded data for the primary outcome. No unexpected serious adverse events were identified. Most patients viewed YCNY favourably. Staff agreed with it in principle, but ward pressures and organisational contexts hampered implementation. There was a need to sustain engagement, provide clarity on roles and responsibilities, and account for fluctuations in patients' health, capacity, and preferences. CONCLUSIONS: If implementation challenges can be overcome, YCNY represents a step towards involving older people as partners in their care to improve the safety and experience of their transitions from hospital to home. TRIAL REGISTRATION: ISRCTN: 51154948.

5.
Trials ; 23(1): 824, 2022 Sep 30.
Article in English | MEDLINE | ID: covidwho-2053955

ABSTRACT

BACKGROUND: This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS2 trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published. METHODS/DESIGN: The original protocol was published in BMC Nephrology ( https://doi.org/10.1186/s12882-019-1325-y ) prior to the commencement of trial recruitment. During the course of the trial, some key methodological changes needed to be made including changes to eligibility criteria (addition of patients with CKD stages 1-2, broadening of financial status eligibility criterion, addition of patients living in rural/remote areas, modification of age eligibility to 0-16 years, addition of limits related to the language spoken by family, guidance regarding families with multiple eligible children), changes to sites, reduction of sample size, addition of virtual options for consent and study procedures in response to the COVID-19 pandemic, removal of staggered recruitment across sites, addition of outcomes, and changes to the timing and number of assessments. This update summarises the changes made and their rationale and provides the detailed plan for statistical analysis of the trial. These changes have been finalised prior to the completion of study follow-up and the commencement of data analysis. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001152213 . Prospectively registered on 12 July 2018.


Subject(s)
COVID-19 , Patient Navigation , Renal Insufficiency, Chronic , Australia , Child , Humans , Multicenter Studies as Topic , Pandemics , Randomized Controlled Trials as Topic , Renal Insufficiency, Chronic/diagnosis , Renal Insufficiency, Chronic/therapy , SARS-CoV-2 , Treatment Outcome
6.
Nutrients ; 14(18)2022 Sep 16.
Article in English | MEDLINE | ID: covidwho-2043873

ABSTRACT

Vitamin D deficiency has been reported to associate with the impaired development of antigen-specific responses following vaccination. We aimed to determine whether vitamin D supplements might boost the immunogenicity and efficacy of SARS-CoV-2 vaccination by conducting three sub-studies nested within the CORONAVIT randomised controlled trial, which investigated the effects of offering vitamin D supplements at a dose of 800 IU/day or 3200 IU/day vs. no offer on risk of acute respiratory infections in UK adults with circulating 25-hydroxyvitamin D concentrations <75 nmol/L. Sub-study 1 (n = 2808) investigated the effects of vitamin D supplementation on the risk of breakthrough SARS-CoV-2 infection following two doses of SARS-CoV-2 vaccine. Sub-study 2 (n = 1853) investigated the effects of vitamin D supplementation on titres of combined IgG, IgA and IgM (IgGAM) anti-Spike antibodies in eluates of dried blood spots collected after SARS-CoV-2 vaccination. Sub-study 3 (n = 100) investigated the effects of vitamin D supplementation on neutralising antibody and cellular responses in venous blood samples collected after SARS-CoV-2 vaccination. In total, 1945/2808 (69.3%) sub-study 1 participants received two doses of ChAdOx1 nCoV-19 (Oxford-AstraZeneca); the remainder received two doses of BNT162b2 (Pfizer). Mean follow-up 25(OH)D concentrations were significantly elevated in the 800 IU/day vs. no-offer group (82.5 vs. 53.6 nmol/L; mean difference 28.8 nmol/L, 95% CI 22.8-34.8) and in the 3200 IU/day vs. no offer group (105.4 vs. 53.6 nmol/L; mean difference 51.7 nmol/L, 45.1-58.4). Vitamin D supplementation did not influence the risk of breakthrough SARS-CoV-2 infection in vaccinated participants (800 IU/day vs. no offer: adjusted hazard ratio 1.28, 95% CI 0.89 to 1.84; 3200 IU/day vs. no offer: 1.17, 0.81 to 1.70). Neither did it influence IgGAM anti-Spike titres, neutralising antibody titres or IFN-γ concentrations in the supernatants of S peptide-stimulated whole blood. In conclusion, vitamin D replacement at a dose of 800 or 3200 IU/day effectively elevated 25(OH)D concentrations, but it did not influence the protective efficacy or immunogenicity of SARS-CoV-2 vaccination when given to adults who had a sub-optimal vitamin D status at baseline.


Subject(s)
COVID-19 Vaccines , COVID-19 , Adult , Antibodies, Neutralizing , BNT162 Vaccine , COVID-19/prevention & control , ChAdOx1 nCoV-19 , Dietary Supplements , Humans , Immunoglobulin A , Immunoglobulin G , Immunoglobulin M , SARS-CoV-2 , Vaccine Efficacy , Vitamin D , Vitamins
7.
Pilot Feasibility Stud ; 8(1): 210, 2022 Sep 16.
Article in English | MEDLINE | ID: covidwho-2038987

ABSTRACT

BACKGROUND: Having a stammer can have a significant effect on a child's social, emotional and educational development. With approximately 66,000 children in the UK having a stammer, there is a need to establish an adequate evidence base to inform clinical practice. We describe a feasibility trial to explore the effectiveness of a new therapy programme for children aged 8-14: Palin Stammering Therapy for School Children (Palin STSC(8-14)). Preliminary data from the Michael Palin Centre, where the programme was developed, indicate that Palin STSC(8-14) is effective in reducing stammering frequency and impact for children, with beneficial effects for parents too. We will investigate the feasibility of the methods required for a definitive randomised controlled trial to investigate the application of this therapy by NHS speech and language therapists (SLTs), compared with 'treatment as usual' (TAU), beyond the specialist context in which it was developed. METHODS: This is a two-arm feasibility cluster-randomised controlled trial of Palin STSC(8-14) with TAU control arm, and randomisation at the level of the SLT. Quantitative and qualitative data will be collected to examine the following: the recruitment and retention of therapists and families, the acceptability of the research processes and the therapeutic intervention and the appropriateness of the therapy outcome measures. Assessments will be completed by children and parents at baseline and 6 months later, including measures of stammering severity; the impact of child's stammering on both children and parents; child temperament, behaviour and peer relations, anxiety; quality of life; and economic outcomes. There will also be a qualitative process evaluation, including interviews with parents, children, SLTs and SLT managers to explore the acceptability of both the research and therapy methods. Treatment fidelity will be examined through analysis of therapy session records and recordings. DISCUSSION: The findings of this feasibility trial will inform the decision as to whether to progress to a full-scale randomised controlled trial to explore the effectiveness of Palin STSC(8-14) when compared to Treatment as Usual in NHS SLT services. There is a strong need for an evidence-based intervention for school age children who stammer. TRIAL REGISTRATION: ISRCTN. ISRCTN17058884 . Registered on 18 December 2019.

8.
Infection ; 2022 Sep 14.
Article in English | MEDLINE | ID: covidwho-2027711

ABSTRACT

BACKGROUND: Coronavirus-associated acute respiratory distress syndrome (CARDS) has limited effective therapy to date. NLRP3 inflammasome activation induced by SARS-CoV-2 in COVID-19 contributes to cytokine storm. METHODS: This randomised, multinational study enrolled hospitalised patients (18-80 years) with COVID-19-associated pneumonia and impaired respiratory function. Eligible patients were randomised (1:1) via Interactive Response Technology to DFV890 + standard-of-care (SoC) or SoC alone for 14 days. Primary endpoint was APACHE II score at Day 14 or on day-of-discharge (whichever-came-first) with worst-case imputation for death. Other key assessments included clinical status, CRP levels, SARS-CoV-2 detection, other inflammatory markers, in-hospital outcomes, and safety. FINDINGS: Between May 27, 2020 and December 24, 2020, 143 patients (31 clinical sites, 12 countries) were randomly assigned to DFV890 + SoC (n = 71) or SoC alone (n = 72). Primary endpoint to establish clinical efficacy of DFV890 vs. SoC, based on combined APACHE II score, was not met; LSM (SE), 8·7 (1.06) vs. 8·6 (1.05); p = 0.467. More patients treated with DFV890 vs. SoC showed ≥ 1-level improvement in clinical status (84.3% vs. 73.6% at Day 14), earlier clearance of SARS-CoV-2 (76.4% vs. 57.4% at Day 7), and mechanical ventilation-free survival (85.7% vs. 80.6% through Day 28), and there were fewer fatal events in DFV890 group (8.6% vs. 11.1% through Day 28). DFV890 was well tolerated with no unexpected safety signals. INTERPRETATION: DFV890 did not meet statistical significance for superiority vs. SoC in primary endpoint of combined APACHE II score at Day 14. However, early SARS-CoV-2 clearance, improved clinical status and in-hospital outcomes, and fewer fatal events occurred with DFV890 vs. SoC, and it may be considered as a protective therapy for CARDS. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04382053.

9.
Trop Med Int Health ; 27(9): 795-802, 2022 09.
Article in English | MEDLINE | ID: covidwho-2019636

ABSTRACT

OBJECTIVE: The government of the Democratic Republic of Congo (DRC) responded to COVID-19 with policy measures, such as business and school closures and distribution of vaccines, which rely on citizen compliance. In other settings, prior experience with effective government programmes has increased compliance with public health measures. We study the effect of a national water, sanitation, and hygiene programme on compliance with COVID-19 policies. METHODS: Prior to the COVID-19 pandemic, 332 communities were randomly assigned to the Villages et Écoles Assainis (VEA) programme or control. After COVID-19 reached DRC, individuals who owned phones (590/1312; 45%) were interviewed by phone three times between May 2020 and August 2021. Primary outcomes were COVID symptoms, non-COVID illness symptoms, child health, psychological well-being, and vaccine acceptance. Secondary outcomes included COVID-19 preventive behaviour and knowledge, and perceptions of governmental performance, including COVID response. All outcomes were self-reported. Outcomes were compared between treatment and control villages using linear models. RESULTS: The VEA programme did not affect respondents' COVID symptoms (-0.11, 95% CI -0.55 to 0.33), non-COVID illnesses (-0.01, 95% CI -0.05 to 0.03), child health (0.07, 95% CI -0.19 to 0.33), psychological well-being (-0.05, 95% CI -0.35 to 0.24), or vaccine acceptance (-0.04, 95% CI -0.19 to 0.10). There was no effect on village-level COVID-19 preventive behaviour (0.03, 95% CI -0.23 to 0.29), COVID-19 knowledge (0.16, 95% CI -0.08 to 0.39), or trust in institutions. CONCLUSIONS: Although the VEA programme increased access to improved water and sanitation, we found no evidence that it increased trust in government or compliance with COVID policies, or reduced illness.


Subject(s)
COVID-19 , Vaccines , COVID-19/epidemiology , COVID-19/prevention & control , Child , Democratic Republic of the Congo/epidemiology , Humans , Hygiene , Pandemics , Sanitation , Water
10.
Br J Psychiatry ; : 1-9, 2022 Aug 30.
Article in English | MEDLINE | ID: covidwho-2009512

ABSTRACT

BACKGROUND: Healthcare workers (HCWs) have faced considerable pressures during the COVID-19 pandemic. For some, this has resulted in mental health distress and disorder. Although interventions have sought to support HCWs, few have been evaluated. AIMS: We aimed to determine the effectiveness of the 'Foundations' application (app) on general (non-psychotic) psychiatric morbidity. METHOD: We conducted a multicentre randomised controlled trial of HCWs at 16 NHS trusts (trial registration number: EudraCT: 2021-001279-18). Participants were randomly assigned to the app or wait-list control group. Measures were assessed at baseline, after 4 and 8 weeks. The primary outcome was general psychiatric morbidity (using the General Health Questionnaire). Secondary outcomes included: well-being; presenteeism; anxiety; depression and insomnia. The primary analysis used mixed-effects multivariable regression, presented as adjusted mean differences (aMD). RESULTS: Between 22 March and 3 June 2021, 1002 participants were randomised (500:502), and 894 (89.2%) followed-up. The sample was predominately women (754/894, 84.3%), with a mean age of 44⋅3 years (interquartile range (IQR) 34-53). Participants randomised to the app had a reduction in psychiatric morbidity symptoms (aMD = -1.39, 95% CI -2.05 to -0.74), improvement in well-being (aMD = 0⋅54, 95% CI 0⋅20 to 0⋅89) and reduction in insomnia (adjusted odds ratio (aOR) = 0⋅36, 95% CI 0⋅21 to 0⋅60). No other significant findings were found, or adverse events reported. CONCLUSIONS: The app had an effect in reducing psychiatric morbidity symptoms in a sample of HCWs. Given it is scalable with no adverse effects, the app may be used as part of an organisation's tiered staff support package. Further evidence is needed on long-term effectiveness and cost-effectiveness.

11.
Pilot Feasibility Stud ; 8(1): 56, 2022 Mar 08.
Article in English | MEDLINE | ID: covidwho-2009484

ABSTRACT

BACKGROUND: The D1 Now intervention is designed to improve outcomes in young adults living with type 1 diabetes. It consists of three components: an agenda-setting tool, an interactive messaging system and a support worker. The aim of the D1 Now pilot cluster randomised controlled trial (RCT) was to gather and analyse acceptability and feasibility data to allow (1) further refinement of the D1 Now intervention, and (2) determination of the feasibility of evaluating the D1 Now intervention in a future definitive RCT. METHODS: A pilot cluster RCT with two intervention arms and a control arm was conducted over 12 months. Quantitative data collection was based on a core outcome set and took place at baseline and 12 months. Semi-structured interviews with participants took place at 6, 9 and 12 months. Fidelity and health economic costings were also assessed. RESULTS: Four diabetes centres and 57 young adults living with type 1 diabetes took part. 50% of eligible young adults were recruited and total loss to follow-up was 12%. Fidelity, as measured on a study delivery checklist, was good but there were three minor processes that were not delivered as intended in the protocol. Overall, the qualitative data demonstrated that the intervention was considered acceptable and feasible, though this differed across intervention components. The agenda-setting tool and support worker intervention components were acceptable to both young adults and staff, but views on the interactive messaging system were mixed. CONCLUSIONS: Some modifications are required to the D1 Now intervention components and research processes but with these in place progression to a definitive RCT is considered feasible. TRIAL REGISTRATION: ISRCTN (ref: ISRCTN74114336 ).

12.
Trials ; 23(1): 737, 2022 Sep 02.
Article in English | MEDLINE | ID: covidwho-2009446

ABSTRACT

BACKGROUND: Despite the intense global research endeavour to improve the treatment of patients with COVID-19, the current therapy remains insufficient, resulting in persisting high mortality. Severe cases are characterised by a systemic inflammatory reaction driven by the release of pro-inflammatory cytokines such as IL-6 and tumour-necrosis-factor alpha (TNF-α). TNF-α-blocking therapies have proved beneficial in patients with chronic inflammatory diseases and could therefore pose a new treatment option in COVID-19. Hitherto, no results from randomised controlled trials assessing the effectiveness and safety of infliximab-a monoclonal antibody targeting TNF-α-in the treatment of COVID-19 have been published. METHODS: In this phase-2 clinical trial, patients with COVID-19 and clinical and laboratory signs of hyperinflammation will be randomised to receive either one dose of infliximab (5 mg/kg body weight) in addition to the standard of care or the standard of care alone. The primary endpoint is the difference in 28-day mortality. Further assessments concern the safety of infliximab therapy in COVID-19 and the influence of infliximab on morbidity and the course of the disease. For the supplementary scientific programme, blood and urine samples are collected to assess concomitant molecular changes. The Ethics Committee of the Friedrich Schiller University Jena (2021-2236-AMG-ff) and the Paul-Ehrlich-Institute (4513/01) approved the study. DISCUSSION: The results of this study could influence the therapy of patients with COVID-19 and affect the course of the disease worldwide, as infliximab is globally available and approved by several international drug agencies. TRIAL REGISTRATION: The trial was registered at clinicaltrials.gov ( NCT04922827 , 11 June 2021) and at EudraCT ( 2021-002098-25 , 19 May 2021).


Subject(s)
COVID-19 , COVID-19/drug therapy , Clinical Trials, Phase II as Topic , Humans , Infliximab/adverse effects , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , SARS-CoV-2 , Treatment Outcome , Tumor Necrosis Factor-alpha
13.
Pilot Feasibility Stud ; 8(1): 179, 2022 Aug 12.
Article in English | MEDLINE | ID: covidwho-2002242

ABSTRACT

BACKGROUND: Evidence from observational studies have shown that moderate intensity physical activity can reduce risk of progression and cancer-specific mortality in participants with prostate cancer. Epidemiological studies have also shown participants taking metformin to have a reduced risk of prostate cancer. However, data from randomised controlled trials supporting the use of these interventions are limited. The Prostate cancer-Exercise and Metformin Trial examines that feasibility of randomising participants diagnosed with localised or locally advanced prostate cancer to interventions that modify physical activity and blood glucose levels. The primary outcomes are randomisation rates and adherence to the interventions over 6 months. The secondary outcomes include intervention tolerability and retention rates, measures of insulin-like growth factor I, prostate-specific antigen, physical activity, symptom-reporting, and quality of life. METHODS: Participants are randomised in a 2 × 2 factorial design to both a physical activity (brisk walking or control) and a pharmacological (metformin or control) intervention. Participants perform the interventions for 6 months with final measures collected at 12 months follow-up. DISCUSSION: Our trial will determine whether participants diagnosed with localised or locally advanced prostate cancer, who are scheduled for radical treatments or being monitored for signs of cancer progression, can be randomised to a 6 months physical activity and metformin intervention. The findings from our trial will inform a larger trial powered to examine the clinical benefits of these interventions. TRIAL REGISTRATION: Prostate Cancer Exercise and Metformin Trial (Pre-EMpT) is registered on the ISRCTN registry, reference number ISRCTN13543667 . Date of registration 2nd August 2018-retrospectively registered. First participant was recruited on 11th September 2018.

14.
Trials ; 23(1): 660, 2022 Aug 15.
Article in English | MEDLINE | ID: covidwho-1993377

ABSTRACT

BACKGROUND: Coronavirus disease-19 (COVID-19) infection causes persistent health problems such as breathlessness, chest pain and fatigue, and therapies for the prevention and early treatment of post-COVID-19 syndromes are needed. Accordingly, we are investigating the effect of a resistance exercise intervention on exercise capacity and health status following COVID-19 infection. METHODS: A two-arm randomised, controlled clinical trial including 220 adults with a diagnosis of COVID-19 in the preceding 6 months. Participants will be classified according to clinical presentation: Group A, not hospitalised due to COVID but persisting symptoms for at least 4 weeks leading to medical review; Group B, discharged after an admission for COVID and with persistent symptoms for at least 4 weeks; or Group C, convalescing in hospital after an admission for COVID. Participants will be randomised to usual care or usual care plus a personalised and pragmatic resistance exercise intervention for 12 weeks. The primary outcome is the incremental shuttle walks test (ISWT) 3 months after randomisation with secondary outcomes including spirometry, grip strength, short performance physical battery (SPPB), frailty status, contacts with healthcare professionals, hospitalisation and questionnaires assessing health-related quality of life, physical activity, fatigue and dyspnoea. DISCUSSION: Ethical approval has been granted by the National Health Service (NHS) West of Scotland Research Ethics Committee (REC) (reference: GN20CA537) and recruitment is ongoing. Trial findings will be disseminated through patient and public forums, scientific conferences and journals. TRIAL REGISTRATION: ClinicialTrials.gov NCT04900961 . Prospectively registered on 25 May 2021.


Subject(s)
COVID-19/complications , Resistance Training , SARS-CoV-2 , Adult , COVID-19/therapy , Chest Pain , Dyspnea , Fatigue , Humans , Quality of Life , Treatment Outcome
15.
BJPsych Advances ; : No Pagination Specified, 2022.
Article in English | APA PsycInfo | ID: covidwho-1962915

ABSTRACT

SUMMARY The COVID-19 pandemic has rapidly accelerated the use of online and remote mental healthcare provision. The immediate need to transform services has not allowed for thorough examination of the literature supporting remote delivery of psychiatric care. In this article we review the history of telepsychiatry, the rationale for continuing to offer services remotely and the limitations of psychiatry without in-person care. Focusing on randomised controlled trials we find that evidence for the efficacy of remotely delivered psychiatric care compared with in-person treatment is of low quality and limited scope but does not demonstrate clear superiority of one care delivery method over the other. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

16.
Trials ; 23(1): 583, 2022 Jul 22.
Article in English | MEDLINE | ID: covidwho-1957067

ABSTRACT

BACKGROUND: The 2020 pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global emergency. COVID-19 appears to be a disease with an early phase where the virus replicates, coinciding with the first presentation of symptoms, followed by a later 'inflammatory' phase which results in severe disease in some individuals. It is known from other rapidly progressive infections such as sepsis and influenza that early treatment with antimicrobials is associated with a better outcome. The hypothesis is that this holds for COVID-19 and that early antiviral treatment may prevent progression to the later phase of the disease. METHODS: Trial design: Phase IIA randomised, double-blind, 2 × 2 design, placebo-controlled, interventional trial. RANDOMISATION: Participants will be randomised 1:1 by stratification, with the following factors: gender, obesity, symptomatic or asymptomatic, current smoking status presence or absence of comorbidity, and if the participant has or has not been vaccinated. BLINDING: Participants and investigators will both be blinded to treatment allocation (double-blind). DISCUSSION: We propose to conduct a proof-of-principle placebo-controlled clinical trial of favipiravir plus or minus nitazoxanide in health workers, their household members and patients treated at the Mexican Social Security Institute (IMSS) facilities. Participants with or without symptomatic COVID-19 or who tested positive will be assigned to receive favipiravir plus nitazoxanide or favipiravir plus nitazoxanide placebo. The primary outcome will be the difference in the amount of virus ('viral load') in the upper respiratory tract after 5 days of therapy. Secondary outcomes will include hospitalization, major morbidity and mortality, pharmacokinetics, and impact of antiviral therapy on viral genetic mutation rate. If favipiravir with nitazoxanide demonstrates important antiviral effects without significant toxicity, there will be a strong case for a larger trial in people at high risk of hospitalization or intensive care admission, for example older patients and/or those with comorbidities and with early disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT04918927 . Registered on June 9, 2021.


Subject(s)
COVID-19 , Amides , Antiviral Agents/adverse effects , COVID-19/drug therapy , Humans , Nitro Compounds , Pyrazines , SARS-CoV-2 , Secondary Prevention , Thiazoles , Treatment Outcome
17.
Transpl Int ; 35: 10365, 2022.
Article in English | MEDLINE | ID: covidwho-1938663
18.
Int J Environ Res Public Health ; 19(13)2022 06 21.
Article in English | MEDLINE | ID: covidwho-1934023

ABSTRACT

BACKGROUND: Mindful parenting and the use of technology for parenting intervention have expanded separately from one another with promising results, but their relationship is underexplored. The current study protocol proposes a new universal intervention via app, MINd Us TOghether (MinUTo), based on mindful parenting for parents of typically developing children of 4-5 years of age. METHODS: The effect of the intervention is evaluated using a randomised controlled trial. Around 2000 parents are enrolled and randomised to the intervention and control groups. Data are collected in three different waves from parents at baseline and endline; APP usage data allow for the analysis of intervention adherence. The MinUTo app proposes contents and activities for five dimensions of mindful parenting. Each dimension is presented within a two-week distance, explaining its importance, providing information, and offering activities for parents and children. EXPECTED RESULTS: We hypothesise a positive effect of the intervention on primary outcomes (mindful parenting, parenting stress, parent behaviours and parental time investment), increasing parents' skills and promoting a positive parent-child relationship. We also test possible effects on secondary outcomes (parenting attitudes and beliefs) at an explorative level. CONCLUSIONS: The study will add new considerations about the psychological and economic impact of technologies in implementing parenting interventions in non-clinical populations.


Subject(s)
Mindfulness , Parenting , Child , Child Rearing , Child, Preschool , Humans , Parent-Child Relations , Parenting/psychology , Randomized Controlled Trials as Topic
19.
Epidemiol Psychiatr Sci ; 31: e39, 2022 Jun 08.
Article in English | MEDLINE | ID: covidwho-1931279

ABSTRACT

AIMS: As refugees and asylum seekers are at high risk of developing mental disorders, we assessed the effectiveness of Self-Help Plus (SH + ), a psychological intervention developed by the World Health Organization, in reducing the risk of developing any mental disorders at 12-month follow-up in refugees and asylum seekers resettled in Western Europe. METHODS: Refugees and asylum seekers with psychological distress (General Health Questionnaire-12 ⩾ 3) but without a mental disorder according to the Mini International Neuropsychiatric Interview (M.I.N.I.) were randomised to either SH + or enhanced treatment as usual (ETAU). The frequency of mental disorders at 12 months was measured with the M.I.N.I., while secondary outcomes included self-identified problems, psychological symptoms and other outcomes. RESULTS: Of 459 participants randomly assigned to SH + or ETAU, 246 accepted to be interviewed at 12 months. No difference in the frequency of any mental disorders was found (relative risk [RR] = 0.841; 95% confidence interval [CI] 0.389-1.819; p-value = 0.659). In the per protocol (PP) population, that is in participants attending at least three group-based sessions, SH + almost halved the frequency of mental disorders at 12 months compared to ETAU, however so few participants and events contributed to this analysis that it yielded a non-significant result (RR = 0.528; 95% CI 0.180-1.544; p-value = 0.230). SH + was associated with improvements at 12 months in psychological distress (p-value = 0.004), depressive symptoms (p-value = 0.011) and wellbeing (p-value = 0.001). CONCLUSIONS: The present study failed to show any long-term preventative effect of SH + in refugees and asylum seekers resettled in Western European countries. Analysis of the PP population and of secondary outcomes provided signals of a potential effect of SH + in the long-term, which would suggest the value of exploring the effects of booster sessions and strategies to increase SH + adherence.


Subject(s)
Mental Disorders , Psychological Distress , Refugees , Stress Disorders, Post-Traumatic , Europe , Health Behavior , Humans , Mental Disorders/epidemiology , Refugees/psychology , Stress Disorders, Post-Traumatic/psychology
20.
J Clin Med ; 11(14)2022 Jul 08.
Article in English | MEDLINE | ID: covidwho-1928590

ABSTRACT

The aim of the study was to explore the effects of Intentional Rounding, a regular-based proactive patient monitoring, on falls and pressure ulcers in internal medicine units. This is a cluster-randomised controlled study, where units were assigned (1:1) to Intentional Rounding (intervention group) or Standard of Care (control group). The primary outcome was the cumulative incidence of falls and new pressure ulcers. These events were considered separately as secondary endpoints, together with the number of bell calls and the evaluation of patient satisfaction. Primary analyses were carried out on the modified intention-to-treat population (hospitalisation of at least 10 days). Recruitment occurred between October 2019 and March 2020, at which time the study was prematurely closed due to the COVID-19 pandemic. Enrolment totalled 1822 patients at 26 sites; 779 patients were included in the modified intention-to-treat analysis. The intervention group had a lower risk of falls (adjusted incidence rate ratio 0.14; 95% confidence interval, 0.02-0.78; p = 0.03). There were no statistical differences in new pressure ulcers or the cumulative incidence of both adverse events. Mean bell calls for each patient were 15.4 ± 24.1 in the intervention group and 13.7 ± 20.5 in the control group (p = 0.38). Additionally, patient satisfaction in the intervention group was almost at the maximum level. Our study supports the usefulness of Intentional Rounding in a complex and vulnerable population such as that hospitalised in internal medicine units.

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