Dataset Information

Protocol for the adolescent hayfever trial: cluster randomised controlled trial of an educational intervention for healthcare professionals for the management of school-age children with hayfever.

ABSTRACT: BACKGROUND:Seasonal allergic rhinitis (hayfever) is common and can contribute to a considerable reduction in the quality of life of adolescents. This study aims to examine the effectiveness of standardised allergy training for healthcare professionals in improving disease-specific quality of life in adolescents with hayfever. METHODS/DESIGN:Adolescents with a history of hayfever registered in general practices in Scotland and England were invited to participate in a cluster randomised controlled trial. The unit of randomisation is general practices.The educational intervention for healthcare professionals consists of a short standardised educational course, which focuses on the management of allergic rhinitis. Patients in the intervention arm of this cluster randomised controlled trial will have a clinic appointment with their healthcare professional who has attended the training course. Patients in the control arm will have a clinic appointment with their healthcare professional and will receive usual care. The primary outcome measure is the change in the Rhinoconjunctivitis Quality of Life Questionnaire with Standardised Activities (RQLQ(S)) score between baseline and six weeks post-intervention in the patient intervention and control groups. Secondary outcome measures relate to healthcare professionals' understanding and confidence in managing allergic rhinitis, changes in clinical practice, numbers of consultations for hayfever and adolescent exam performance.A minimum of 11 practices in each arm of the trial (10 patients per cluster) will provide at least 80% power to demonstrate a minimal clinically important difference of 0.5 in RQLQ(S) score at a significance level of 5% based on an Intraclass Correlation Coefficient (ICC) of 0.02. DISCUSSION:At the time of submission, 24 general practices have been recruited (12 in each arm of the trial) and the interventions have been delivered. Follow-up data collection is complete. 230 children consented to take part in the trial; however complete primary outcome data are only available for 160. Further recruitment of general practices and patients will therefore take place in the summer of 2010. TRIAL REGISTRATION:Current Controlled Trials ISRCTN95538067.

SUBMITTER: Hammersley VS

PROVIDER: S-EPMC2922085 | biostudies-literature | 2010 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Protocol for the adolescent hayfever trial: cluster randomised controlled trial of an educational intervention for healthcare professionals for the management of school-age children with hayfever.

Hammersley Victoria S VS Walker Samantha S Elton Rob R Sheikh Aziz A

Trials 20100805

<h4>Background</h4>Seasonal allergic rhinitis (hayfever) is common and can contribute to a considerable reduction in the quality of life of adolescents. This study aims to examine the effectiveness of standardised allergy training for healthcare professionals in improving disease-specific quality of life in adolescents with hayfever.<h4>Methods/design</h4>Adolescents with a history of hayfever registered in general practices in Scotland and England were invited to participate in a cluster random ...[more]

PMID: 20687917

Similar Datasets

Project description:INTRODUCTION:Childhood vaccination programmes have been established in all Organisation for Economic Co-operation and Development (OECD) countries; however, measles, mumps and rubella (MMR) as well as diphtheria, tetanus, pertussis and polio (Tdap-IPV) vaccination rates are not optimal in adolescents. Education in combination with easy access vaccination may be a promising approach to improve vaccination rates. We aim at improving MMR and Tdap-IPV rates in a school setting in the context of a planned cluster randomised controlled trial (cRCT), the present paper describes the detailed protocol of this trial. METHODS AND ANALYSIS:We will conduct a school-based cRCT, where schools will be randomised to either an educational condition addressing knowledge, risk communication and enhancing self-efficacy regarding vaccination or a low-intensity information condition. In both conditions, a bus equipped with medical staff and materials, will be delivering MMR and Tdap-IPV vaccine directly after the intervention. Schools in the city centre of Berlin, Germany, will be stratified by percentage of migration and type of school. Primary outcome is the number of students who receive vaccination in the bus. Secondary outcomes are knowledge and self-efficacy. An estimated sample size of 355 school classes with approximately 25 students per class is required. The planned analyses will take the nested structure of students, classes and schools into account. ETHICS AND DISSEMINATION:The study will be performed according to the principles of Good Clinical Practice and the Declaration of Helsinki. Approval was obtained by the local ethics committee. Parents of all students will be informed in advance. Their written consent will be obtained, in case students are underage. For dissemination, we will engage with governmental organisations to create potential of our educational unit to be included in future public health prevention schemes. TRIAL REGISTRATION NUMBER:ISRCTN18026662;Pre-results.

Project description:BackgroundStrengthening Evidence base on scHool-based intErventions for pRomoting adolescent health (SEHER) is a multicomponent, whole-school health promotion intervention delivered by a lay counsellor or a teacher in government-run secondary schools in Bihar, India. The objective of this study is to examine the effects of the intervention after two years of follow-up and to evaluate the consistency of the findings observed over time.Methods and findingsWe conducted a cluster randomised trial in which 75 schools were randomised (1:1:1) to receive the SEHER intervention delivered by a lay counsellor (SEHER Mitra [SM]) or a teacher (Teacher as SEHER Mitra [TSM]), respectively, alongside a standardised, classroom-based life skills Adolescence Education Program (AEP), compared to AEP alone (control group). The trial design was a repeat cross-sectional study. Students enrolled in grade 9 (aged 13-15 years) in the 2015-2016 academic year were exposed to the intervention for two years and the outcome assessment was conducted at three time points─at baseline in June 2015; 8-months follow-up in March 2016, when the students were still in grade 9; and endpoint at 17-months follow-up in December 2016 (when the students were in grade 10), the results of which are presented in this paper. The primary outcome, school climate, was measured with the Beyond Blue School Climate Questionnaire (BBSCQ). Intervention effects were estimated using mixed-effects linear or logistic regression, including a random effect to adjust for within-school clustering, minimisation variables, baseline cluster-level score of the outcome, and sociodemographic characteristics. In total, 15,232 students participated in the 17-month survey. Compared with the control group, the participants in the SM intervention group reported improvements in school climate (adjusted mean difference [aMD] = 7.33; 95% CI: 6.60-8.06; p < 0.001) and most secondary outcomes (depression: aMD = -4.64; 95% CI: -5.83-3.45; p < 0.001; attitude towards gender equity: aMD = 1.02; 95% CI: 0.65-1.40; p < 0.001; frequency of bullying: aMD = -2.77; 95% CI: -3.40 to -2.14; p < 0.001; violence victimisation: odds ratio [OR] = 0.08; 95% CI: 0.04-0.14; p < 0.001; and violence perpetration: OR = 0.16; 95% CI: 0.09-0.29; p < 0.001). There was no evidence of an intervention effect in the TSM group compared with control group. The effects of the lay counsellor-delivered intervention were larger for most outcomes at 17-months follow-up compared with those at 8 months: school climate (effect size [ES; 95% CI] = 2.23 [1.97-2.50] versus 1.88 [1.44-2.32], p < 0.001); depression (ES [95% CI] = -1.19 [-1.56 to -0.82] versus -0.27 [-0.44 to -0.11], p < 0.001); attitude towards gender equity (ES [95% CI] = 0.53 [0.27-0.79] versus 0.23 [0.10-0.36], p < 0.001); bullying (ES [95% CI] = -2.22 [-2.84 to -1.60] versus -0.47 [-0.61 to -0.33], p < 0.001); violence victimisation (OR [95% CI] = 0.08 [0.04-0.14] versus 0.62 [0.46-0.84], p < 0.001); and violence perpetration (OR [95% CI] = 0.16 [0.09-0.29] versus 0.68 [0.48-0.96], p < 0.001), suggesting incremental benefits with an extended intervention. A limitation of the study is that 27% of baseline participants did not complete the 17-month outcome assessment.ConclusionsThe trial showed that the second-year outcomes were similar to the first-year outcomes, with no effect of the teacher-led intervention and larger benefits on school climate and adolescent health accruing from extending lay counsellor-delivered intervention.Trial registrationClinicalTrials.gov NCT02907125.

Project description:ObjectivesInterventions addressing the individual and environmental protective factors of adolescents are suggested to have potential for reducing adolescent substance use. While universally delivered school-based substance use prevention interventions are common, previous studies have suggested variable effectiveness by subgroups of students. An exploratory study was undertaken to examine the differential effectiveness of a universal school-based resilience intervention on adolescent substance use and protective factors according to their sociodemographic and previous substance use.DesignSecondary analysis of data from a cluster-randomised controlled trial.Setting32 Australian secondary schools.ParticipantsCohort of grade 7 students (n=3155) followed up in grade 10 (aged 15-16 years; 2014; n=2105).InterventionThree-year universal school-based intervention implemented by school staff that targeted a range of student resilience protective factors (2012-2014).MeasurementsPrimary outcomes included: tobacco (recent, number of cigarettes) and alcohol (recent, 'risk' and number of drinks) use, and secondary outcomes included: marijuana (recent) and other illicit substance (recent) use, and aggregate individual and environmental protective factor scores. Generalised and linear mixed models examined interactions between treatment and student subgroups (gender; socioeconomic disadvantage (low/high); geographic location (major city/inner regional/outer regional-remote); and previous substance use (non-user/user)) at follow-up (36 models).ResultsAnalysis of student follow-up data showed no differential intervention effect for any substance use or protective factor outcome for any subgroup, with the exception of one differential effect found by socioeconomic status for the outcome of mean number of cigarettes smoked by recent smokers (p=0.003). There was no evidence of an intervention effect within the low (mean difference (MD) -12.89, 95% CI -26.00 to 0.23) or high (MD 16.36, 95% CI -1.03 to 33.76) socioeconomic subgroups.ConclusionsNo evidence of an intervention effect on substance use and protective factors was found according to student subgroups defined by sociodemographic characteristics or previous substance use.Trial registration numberACTRN12611000606987.

Project description:BackgroundSecondary education and delayed marriage provide long-term socio-economic and health benefits to adolescent girls. We tested whether a structural and norms-based intervention, which worked with adolescent girls, their families, communities, and secondary schools to address poverty, schooling quality and gender norms, could reduce secondary school drop-out and child marriage among scheduled-caste/scheduled-tribe (SC/ST) adolescent girls in rural settings of southern India.Methods80 of 121 villages in Vijayapura and Bagalkote districts, Karnataka State, were randomly selected (control = 40; intervention = 40). All 12-13 year-old SC/ST girls in final year of primary school (standard 7th) were enrolled and followed for 3 years (2014-2017) until the end of secondary school (standard 10th). Primary trial outcomes were proportion of girls who completed secondary school and were married, by trial end-line (15-16 years). Analyses were intention-to-treat and used individual-level girl data.Results92.6% (2275/2457) girls at baseline and 72.8% (1788/2457) at end-line were interviewed. At end-line, one-fourth had not completed secondary school (control = 24.9%; intervention = 25.4%), and one in ten reported being married (control = 9.6%; intervention = 10.1%). These were lower than expected based on district-level data available before the trial, with no difference between these, or other schooling or sexual and reproductive outcomes, by trial arm. There was a small but significant increase in secondary school entry (adjusted odds ratio AOR = 3.58, 95% confidence interval CI = 1.36-9.44) and completion (AOR=1.54, 95%CI = 1.02-2.34) in Vijayapura district. The sensitivity and attrition analyses did not impact the overall result indicating that attrition of girls at end-line was random without much bearing on overall result.ConclusionsSamata intervention had no overall impact, however, it added value in one of the two implementation districts- increasing secondary school entry and completion. Lower than expected school drop-out and child marriage rates at end-line reflect strong secular changes, likely due to large-scale government initiatives to keep girls in school and delay marriage. Although government programmes may be sufficient to reach most girls in these settings, a substantial proportion of SC/ST girls remain at-risk of early marriage and school drop-out, and require targeted programming. Addressing multiple forms of clustered disadvantage among hardest to reach will be key to ensuring India "leaves no-one behind" and achieves its gender, health and education Sustainable Development Goal aspirations.Trial registrationClinicalTrials.gov registration number NCT01996241.

Project description:Background The control of hypertension is low in low- and middle-income countries like India. We evaluated the effects of a nurse-facilitated educational intervention in improving the control rate of hypertension among school teachers in India. Methods and Results This was a cluster-randomized controlled trial involving 92 schools in Kerala, which were randomly assigned equally into a usual care group and an intervention group. Participants were 402 school teachers (mean age, 47 years; men, 29%) identified with hypertension. Participants in both study groups received a leaflet containing details of a healthy lifestyle and the importance of regular intake of antihypertensive medication. In addition, the intervention participants received a nurse-facilitated educational intervention on hypertension control for 3 months. The primary outcome was hypertension control. Key secondary outcomes included systolic blood pressure, diastolic blood pressure, and the proportion of participants taking antihypertensive medications. For the primary outcome, we used mixed-effects logistic regression models. Two months after a 3-month educational intervention, a greater proportion of intervention participants (49.0%) achieved hypertension control than the usual care participants (38.2%), with an odds ratio of 1.89 (95% CI, 1.06-3.35), after adjusting for baseline hypertension control. The odds of taking antihypertensive medications were 1.6 times higher in the intervention group compared with the usual care group (odds ratio, 1.62; 95% CI, 1.08-2.45). The reduction in mean systolic blood pressure was significantly greater in the intervention group by 4.2 mm Hg (95% CI, -7.2 to -1.1) than in the usual care group. Conclusions A nurse-facilitated educational intervention was effective in improving the control and treatment rates of hypertension as well as reducing systolic blood pressure among schoolteachers with hypertension. Registration URL: https://www.ctri.nic.in; Unique Identifier: CTRI/2018/01/011402.

Project description:BackgroundMost adolescent girls in the UK do not meet government physical activity recommendations and effective interventions are needed. This study reports the results of a feasibility trial of PLAN-A, a novel school-based peer-led physical activity intervention for adolescent girls.MethodsA two-arm cluster randomised controlled feasibility study was conducted in six English secondary schools (4 intervention & 2 control). Year 8 (age 12-13) girls were eligible and randomisation was at school-level. The intervention involved training Year 8 girls (out of school for two consecutive days, plus one top-up day 5 weeks later), who were identified by their peers as influential, to provide informal support to their friends to increase their physical activity. Feasibility of the intervention and the research was examined, including: recruitment, training attendance and data provision rates, evidence of promise of the intervention to affect weekday moderate-to-vigorous physical activity (MVPA), intervention cost and estimation of the sample size for a definitive trial. Accelerometer and questionnaire data were collected at the beginning of Year 8 (Time 0), the end of Year 8 (10-weeks after peer-supporter training) and the beginning of Year 9 (Time 2).ResultsFour hundred twenty-seven girls were recruited (95% recruitment rate). 55 girls consented to be a peer-supporter and 53 peer-supporters were trained (97% of those invited). Accelerometer return rates exceeded 85% at each time point and wear time criteria was met by 83%, 71% and 62% participants at Time 0, 1 and 2 respectively. Questionnaire data were provided by >91% of participants at each time point. Complete-case adjusted linear regression analysis showed evidence of a 6.09 minute (95% CI = 1.43, 10.76) between-arms difference in weekday MVPA at Time 2 in favour of the intervention arm. On average PLAN-A cost £2685 per school to deliver (£37 per Year 8 girl). There were no adverse events. A trial involving 20 schools would be adequately powered to detect a between-arms difference in weekday MVPA of at least six minutes.ConclusionsThe PLAN-A intervention adopts a novel peer-led approach, is feasible, and shows evidence of promise to positively affect girls' physical activity levels. A definitive trial is warranted.Trial registrationISCTRN, ISRCTN12543546, Registered on 28/7/2015, URL of registry record: http://www.isrctn.com/ISRCTN12543546.

Project description:IntroductionSecondary schools have the transformative potential to advance adolescent nutrition and provide a unique entry point for nutrition interventions to reach adolescents and their families and communities. Integrated school nutrition interventions offer promising pathways towards improving adolescent nutrition status, food security and building sustainable skill sets.Methods and analysisThe Meals, Education, and Gardens for In-School Adolescents (MEGA) project aims to implement and evaluate an integrated, school-based nutrition intervention package among secondary schools in the Chamwino District of Dodoma, Tanzania. MEGA is a cluster-randomised controlled trial, including six public secondary schools assigned to three different arms. Two schools will receive the full intervention package, including school meals, school gardens, nutrition education and community workshops. Two schools will receive the partial intervention package, including the school garden, nutrition education and community workshops. Two schools will serve as the controls and will not receive any intervention. The intervention will be implemented for one academic year. Baseline and end-line quantitative data collection will include 750 adolescents and 750 parents. The domains of outcomes for adolescents will include haemoglobin concentrations, anthropometry, educational outcomes and knowledge, attitudes and practices regarding nutrition, agriculture and health. The domains of outcomes for parents will include knowledge, attitudes and practices of nutrition, agriculture and health. End-line focus group discussions will be conducted among selected adolescents, parents and teachers to assess the facilitators and barriers associated with the intervention.Ethics and disseminationThis study was approved by the Institutional Review Board at Harvard T.H. Chan School of Public Health (approval number: IRB20-1623), the Institutional Research Review Committee at the University of Dodoma (approval number: MA.84/261/02) and the Tanzania National Institute for Medical Research (approval number: NIMR/HO/R.8a/Vol. IX/3801). A manuscript with the research findings will be developed for publication. Local dissemination meetings will be held with key stakeholders.Trial registration numberNCT04788303.; ClinicalTrials.gov Identifier.

Dataset Information

Protocol for the adolescent hayfever trial: cluster randomised controlled trial of an educational intervention for healthcare professionals for the management of school-age children with hayfever.

Publications

Protocol for the adolescent hayfever trial: cluster randomised controlled trial of an educational intervention for healthcare professionals for the management of school-age children with hayfever.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets