Browsing by Subject "Randomised controlled trial"

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    A food-based dietary strategy lowers blood pressure in a low socio-economic setting: a randomised study in South Africa
    (2008) Charlton, Karen E; Steyn, Krisela; Levitt, Naomi S; Peer, Nasheeta; Jonathan, Deborah; Gogela, Theresa; Rossouw, Katja; Gwebushe, Nomonde; Lombard, Carl J
    OBJECTIVE: To assess the impact of a food-based intervention on blood pressure (BP) in free-living South African men and women aged 50-75 years, with drug-treated mild-to-moderate hypertension. METHODS: A double-blind controlled trial was undertaken in eighty drug-treated mild-to-moderate hypertensive subjects randomised to an intervention (n 40) or control (n 40) arm. The intervention was 8-week provision of six food items with a modified cation content (salt replacement (SOLO ), bread, margarine, stock cubes, soup mix and a flavour enhancer) and 500 ml of maas (fermented milk)/d. The control diet provided the same quantities of the targeted foods but of standard commercial composition and 500 ml/d of artificially sweetened cooldrink. FINDINGS: The intervention effect estimated as the contrast of the within-diet group changes in BP from baseline to post-intervention was a significant reduction of 6.2 mmHg (95 % CI 0.9, 11.4) for systolic BP. The largest intervention effect in 24 h BP was for wake systolic BP with a reduction of 5.1 mmHg (95 % CI 0.4, 9.9). For wake diastolic BP the reduction was 2.7 mmHg (95 % CI -0.2, 5.6). CONCLUSIONS: Modification of the cation content of a limited number of commonly consumed foods lowers BP by a clinically significant magnitude in treated South African hypertensive patients of low socio-economic status. The magnitude of BP reduction provides motivation for a public health strategy that could be adopted through lobbying of the food industry by consumer and health agencies.
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    AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter
    (2021-07-26) Griffiths, Gareth O; FitzGerald, Richard; Jaki, Thomas; Corkhill, Andrea; Reynolds, Helen; Ewings, Sean; Condie, Susannah; Tilt, Emma; Johnson, Lucy; Radford, Mike; Simpson, Catherine; Saunders, Geoffrey; Yeats, Sara; Mozgunov, Pavel; Tansley-Hancock, Olana; Martin, Karen; Downs, Nichola; Eberhart, Izabela; Martin, Jonathan W B; Goncalves, Cristiana; Song, Anna; Fletcher, Tom; Byrne, Kelly; Lalloo, David G; Owen, Andrew; Jacobs, Michael; Walker, Lauren; Lyon, Rebecca; Woods, Christie; Gibney, Jennifer; Chiong, Justin; Chandiwana, Nomathemba; Jacob, Shevin; Lamorde, Mohammed; Orrell, Catherine; Pirmohamed, Munir; Khoo, Saye
    Background There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. A number of COVID-19 late phase trial platforms have been developed to investigate (often repurposed) drugs both in the UK and globally (e.g. RECOVERY led by the University of Oxford and SOLIDARITY led by WHO). There is a pressing need to investigate novel candidates within early phase trial platforms, from which promising candidates can feed into established later phase platforms. AGILE grew from a UK-wide collaboration to undertake early stage clinical evaluation of candidates for SARS-CoV-2 infection to accelerate national and global healthcare interventions. Methods/design AGILE is a seamless phase I/IIa platform study to establish the optimum dose, determine the activity and safety of each candidate and recommend whether it should be evaluated further. Each candidate is evaluated in its own trial, either as an open label single arm healthy volunteer study or in patients, randomising between candidate and control usually in a 2:1 allocation in favour of the candidate. Each dose is assessed sequentially for safety usually in cohorts of 6 patients. Once a phase II dose has been identified, efficacy is assessed by seamlessly expanding into a larger cohort. AGILE is completely flexible in that the core design in the master protocol can be adapted for each candidate based on prior knowledge of the candidate (i.e. population, primary endpoint and sample size can be amended). This information is detailed in each candidate specific trial protocol of the master protocol. Discussion Few approved treatments for COVID-19 are available such as dexamethasone, remdesivir and tocilizumab in hospitalised patients. The AGILE platform aims to rapidly identify new efficacious and safe treatments to help end the current global COVID-19 pandemic. We currently have three candidate specific trials within this platform study that are open to recruitment. Trial registration EudraCT Number: 2020-001860-27 14 March 2020 ClinicalTrials.gov Identifier: NCT04746183  19 February 2021 ISRCTN reference: 27106947
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    Comparison of an interactive with a didactic educational intervention for improving the evidence-based practice knowledge of occupational therapists in the public health sector in South Africa: a randomised controlled trial
    (2014-06-10) Buchanan, Helen; Siegfried, Nandi; Jelsma, Jennifer; Lombard, Carl
    Background: Despite efforts to identify effective interventions to implement evidence-based practice (EBP), uncertainty remains. Few existing studies involve occupational therapists or resource-constrained contexts. This study aimed to determine whether an interactive educational intervention (IE) was more effective than a didactic educational intervention (DE) in improving EBP knowledge, attitudes and behaviour at 12 weeks. Methods: A matched pairs design, randomised controlled trial was conducted in the Western Cape of South Africa. Occupational therapists employed by the Department of Health were randomised using matched-pair stratification by type (clinician or manager) and knowledge score. Allocation to an IE or a DE was by coin-tossing. A self-report questionnaire (measuring objective knowledge and subjective attitudes) and audit checklist (measuring objective behaviour) were completed at baseline and 12 weeks. The primary outcome was EBP knowledge at 12 weeks while secondary outcomes were attitudes and behaviour at 12 weeks. Data collection occurred at participants’ places of employment. Audit raters were blinded, but participants and the provider could not be blinded. Results: Twenty-one of 28 pairs reported outcomes, but due to incomplete data for two participants, 19 pairs were included in the analysis. There was a median increase of 1.0 points (95% CI = -4.0, 1.0) in the IE for the primary outcome (knowledge) compared with the DE, but this difference was not significant (P = 0.098). There were no significant differences on any of the attitude subscale scores. The median 12-week audit score was 8.6 points higher in the IE (95% CI = -7.7, 27.0) but this was not significant (P = 0.196). Within-group analyses showed significant increases in knowledge in both groups (IE: T = 4.0, P <0.001; DE: T = 12.0, P = 0.002) but no significant differences in attitudes or behaviour. Conclusions: The results suggest that the interventions had similar outcomes at 12 weeks and that the interactive component had little additional effect.
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    Comparison of an interactive with a didactic educational intervention for improving the evidence-based practice knowledge of occupational therapists in the public health sector in South Africa: a randomised controlled trial
    (2014-06-10) Buchanan, Helen; Siegfried, Nandi; Jelsma, Jennifer; Lombard, Carl
    Abstract Background Despite efforts to identify effective interventions to implement evidence-based practice (EBP), uncertainty remains. Few existing studies involve occupational therapists or resource-constrained contexts. This study aimed to determine whether an interactive educational intervention (IE) was more effective than a didactic educational intervention (DE) in improving EBP knowledge, attitudes and behaviour at 12 weeks. Methods A matched pairs design, randomised controlled trial was conducted in the Western Cape of South Africa. Occupational therapists employed by the Department of Health were randomised using matched-pair stratification by type (clinician or manager) and knowledge score. Allocation to an IE or a DE was by coin-tossing. A self-report questionnaire (measuring objective knowledge and subjective attitudes) and audit checklist (measuring objective behaviour) were completed at baseline and 12 weeks. The primary outcome was EBP knowledge at 12 weeks while secondary outcomes were attitudes and behaviour at 12 weeks. Data collection occurred at participants’ places of employment. Audit raters were blinded, but participants and the provider could not be blinded. Results Twenty-one of 28 pairs reported outcomes, but due to incomplete data for two participants, 19 pairs were included in the analysis. There was a median increase of 1.0 points (95% CI = -4.0, 1.0) in the IE for the primary outcome (knowledge) compared with the DE, but this difference was not significant (P = 0.098). There were no significant differences on any of the attitude subscale scores. The median 12-week audit score was 8.6 points higher in the IE (95% CI = -7.7, 27.0) but this was not significant (P = 0.196). Within-group analyses showed significant increases in knowledge in both groups (IE: T = 4.0, P <0.001; DE: T = 12.0, P = 0.002) but no significant differences in attitudes or behaviour. Conclusions The results suggest that the interventions had similar outcomes at 12 weeks and that the interactive component had little additional effect. Trial registration Pan African Controlled Trials Register PACTR201201000346141 , registered 31 January 2012. Clinical Trials NCT01512823 , registered 1 February 2012. South African National Clinical Trial Register DOH2710093067 , registered 27 October 2009. The first participants were randomly assigned on 16 July 2008.
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    Efficacy of an alcohol-focused intervention for improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes – a randomised controlled trial protocol
    (2014-09-12) Parry, Charles D; Morojele, Neo K; Myers, Bronwyn J; Kekwaletswe, Connie T; Manda, Samuel O; Sorsdahl, Katherine; Ramjee, Gita; Hahn, Judith A; Rehm, Jürgen; Shuper, Paul A
    Abstract Background Little research has examined whether alcohol reduction interventions improve antiretroviral therapy (ART) adherence and HIV treatment outcomes. This study assesses the efficacy of an intervention for reducing alcohol use among HIV patients on ART who are hazardous/harmful drinkers. Specific aims include adapting a blended Motivational Interviewing (MI) and Problem Solving Therapy (PST) intervention for use with HIV patients; evaluating the efficacy of the intervention for reducing alcohol consumption; and assessing counsellors’ and participants’ perceptions of the intervention. Methods/Design A randomised controlled trial will evaluate the intervention among ART patients in public hospital-based HIV clinics in Tshwane, South Africa. We will recruit patients who are HIV-positive, on ART for at least 3 months, and classified as harmful/hazardous drinkers using the AUDIT-3. Eligible patients will be randomly assigned to one of three conditions. Patients in the experimental group will receive the MI-PST intervention to reduce harmful/hazardous alcohol use. Patients in the equal-attention wellness intervention group will receive an intervention focused on addressing health risk behaviours. Patients in the control condition will receive treatment as usual. Participants will complete an interviewer-administered questionnaire at baseline and 3, 6 and 12 months post-randomisation to assess alcohol consumption, ART adherence, physical and mental health. We will also collect biological specimens to test for recent alcohol consumption, CD4 counts and HIV RNA viral loads. The primary outcome will be reduction in the volume of alcohol consumed. Secondary outcomes include reduction in harmful/hazardous use of alcohol, reduction in biological markers of drinking, increase in adherence rates, reductions in viral loads, and increases in CD4 T-cell counts. A process evaluation will ascertain counsellors’ and participants’ perceptions of the acceptability and effectiveness of the interventions. Discussion We have obtained ethical approval and approval from the study sites and regional and provincial health departments. The study has implications for clinicians, researchers and policy makers as it will provide efficacy data on how to reduce harmful/hazardous alcohol consumption among HIV patients and will shed light on whether reducing alcohol consumption impacts on HIV treatment adherence and other outcomes. Trial registration Pan African Clinical Trials Register Number: PACTR201405000815100 .
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    Escitalopram in the prevention of posttraumatic stress disorder: a pilot randomized controlled trial
    (BioMed Central, 2015-02-19) Suliman, Sharain; Seedat, Soraya; Pingo, Janine; Sutherland, Taryn; Zohar, Joseph; Stein, Dan J
    Background: A small literature suggests that pharmacotherapy may be useful in the prophylaxis of posttraumatic stress disorder in patients presenting with major trauma. There is relatively little data, however, on the use of selective serotonin reuptake inhibitors (SSRIs) in this context. Methods: 24 week, double-blind placebo controlled study. 31 participants presenting immediately after trauma, and meeting diagnostic criteria for full or partial acute stress disorder were randomized to treatment with 10–20 mg of escitalopram or placebo daily for 24 weeks. 2 participants were excluded from the analysis due to early drop out, leaving 29 participants (escitalopram = 12, placebo = 17) for inclusion in an intent- to- treat analysis. Participants were followed up until 56 weeks, and assessed with the Clinician Administered PTSD Scale (CAPS). A mixed model repeated measures analysis of variance (RMANOVA) was undertaken to determine the efficacy of the intervention on the CAPS score. Results: There was a significant reduction in CAPS score over the course of treatment (F(7, 142) = 41. 58, p < 0.001) in both the escitalopram and placebo groups, with a greater reduction in CAPS score in the placebo group F(7, 142) = 2.12, p = 0.045. There were improvements on all secondary measures, including the Clinical Global Impressions scale, and scales assessing depression, anxiety and disability. Only functional disability outcomes (F(7, 141) = 2.13, p = .04), were significantly different between treatment and placebo groups. In the sample as a whole, improvement in scores were maintained at the 52 week follow-up. Side effects were comparable between the groups. Conclusions: These data are consistent with other recent work indicating that the SSRIs may not be efficacious in the prevention of PTSD. Nevertheless, the small sample size and baseline differences between groups limit the explanatory power of the study. Although a consideration of the possibility of medication prophylaxis in PTSD remains important, both from conceptual and clinical perspectives, caution is needed with regards to the use of SSRIs until their efficacy can be proven. Trial registration: Clinical Trials NCT00300313