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Clustered randomised trial of an intervention to improve the management of asthma: Greenwich asthma study.

ABSTRACT: OBJECTIVES:To evaluate the effectiveness of an asthma resource centre in improving treatment and quality of life for asthmatic patients. DESIGN:Community based randomised controlled trial. SETTING:41 general practices in Greenwich with a practice nurse. SUBJECTS:All registered patients aged 15-50 years. INTERVENTION:Nurse specialists in asthma who educated and supported practice nurses, who in turn educated patients in the management of asthma according to the British Thoracic Society's guidelines. MAIN OUTCOME MEASURES:Quality of life of asthmatic patients, attendance at accident and emergency departments, admissions to local hospitals, and steroid prescribing by general practitioners. RESULTS:Of 24 400 patients randomly selected and surveyed in 1993, 12 238 replied; 1621 were asthmatic of whom 1291 were sent a repeat questionnaire in 1996 and 780 replied. Of 24 400 patients newly surveyed in 1996, 10 783 (1616 asthmatic) replied. No evidence was found for an improvement in asthma related quality of life among newly surveyed patients in intervention practices compared with control practices. Neither was there evidence of an improvement in other measures of the quality of asthma care. Weak evidence was found for an improvement in quality of life in intervention practices among asthmatics registered with study practices in 1993 and followed up in 1996. Neither attendances at accident and emergency departments nor admissions for asthma showed any tendency to diverge in intervention and control practices over the study period. Steroid prescribing rates rose steadily during the study period. The average annual increase in steroid prescribing was 3% per year higher in intervention than control practices (95% confidence interval -1% to 6%, P=0.10). CONCLUSIONS:This model of service delivery is not effective in improving the outcome of asthma in the community. Further development is required if cost effective management of asthma is to be introduced.

SUBMITTER: Premaratne UN

PROVIDER: S-EPMC27864 | biostudies-literature | 1999 May

REPOSITORIES: biostudies-literature

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Clustered randomised trial of an intervention to improve the management of asthma: Greenwich asthma study.

Premaratne U N UN Sterne J A JA Marks G B GB Webb J R JR Azima H H Burney P G PG

BMJ (Clinical research ed.) 19990501 7193

<h4>Objectives</h4>To evaluate the effectiveness of an asthma resource centre in improving treatment and quality of life for asthmatic patients.<h4>Design</h4>Community based randomised controlled trial.<h4>Setting</h4>41 general practices in Greenwich with a practice nurse.<h4>Subjects</h4>All registered patients aged 15-50 years.<h4>Intervention</h4>Nurse specialists in asthma who educated and supported practice nurses, who in turn educated patients in the management of asthma according to the ...[more]

PMID: 10231256

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Project description:To evaluate the feasibility of a phase 3 randomised controlled trial (RCT) of a website (Living Well with Asthma) to support self-management.Phase 2, parallel group, RCT, participants recruited from 20 general practices across Glasgow, UK. Randomisation through automated voice response, after baseline data collection, to website access for minimum 12 weeks or usual care.Adults (age≥16 years) with physician diagnosed, symptomatic asthma (Asthma Control Questionnaire (ACQ) score ≥1). People with unstable asthma or other lung disease were excluded.'Living Well with Asthma' is a desktop/laptop compatible interactive website designed with input from asthma/ behaviour change specialists, and adults with asthma. It aims to support optimal medication management, promote use of action plans, encourage attendance at asthma reviews and increase physical activity.Primary outcomes were recruitment/retention, website use, ACQ and mini-Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included patient activation, prescribing, adherence, spirometry, lung inflammation and health service contacts after 12 weeks. Blinding postrandomisation was not possible.Recruitment target met. 51 participants randomised (25 intervention group). Age range 16-78 years; 75% female; 28% from most deprived quintile. 45/51 (88%; 20 intervention group) followed up. 19 (76% of the intervention group) used the website, for a mean of 18 min (range 0-49). 17 went beyond the 2 'core' modules. Median number of logins was 1 (IQR 1-2, range 0-7). No significant difference in the prespecified primary efficacy measures of ACQ scores (-0.36; 95% CI -0.96 to 0.23; p=0.225), and mini-AQLQ scores (0.38; -0.13 to 0.89; p=0.136). No adverse events.Recruitment and retention confirmed feasibility; trends to improved outcomes suggest use of Living Well with Asthma may improve self-management in adults with asthma and merits further development followed by investigation in a phase 3 trial.ISRCTN78556552; Results.

Project description:IntroductionAsthma is the most common chronic disease among children worldwide, with 80% of asthma-related deaths occurring in low- and middle-income countries (LMICs). While evidence-based guidelines exist for asthma treatment and management, adoption of guideline-based practices is low in high-income country and LMIC settings alike. While asthma prevalence among children and adolescents in Lima, Peru is in the range of 13%-19.6%, our data suggest that < 5% of children in low-resource communities are currently taking guideline-based therapies. There is an urgent need for effective, locally tailored solutions to address the asthma treatment gap in low-income communities in Peru.MethodsThis study aims to develop and test a locally adapted intervention package to improve adoption of self-management practices and utilization of preventive health services for asthma among children in Lima Norte. The intervention package was designed using a systematic, theory-based framework (Capability, Opportunity, Motivation - Behavior Framework) and is rooted in a multi-phased formative research approach. The main study design is an individually randomized implementation-effectiveness hybrid trial enrolling 110 children aged 5-17 years with asthma and their caregivers. Families allocated to the treatment group receive the supported self-management intervention package, while families allocated to the control group receive the standard of care plus asthma education. We will follow participants monthly for six months and evaluate asthma control (Asthma Control Test), healthcare utilization, and medication adherence (Adherence to Refills and Medications Scale). Disease-specific quality of life for children (Pediatric Asthma Quality of Life Questionnaire) and caregivers (Pediatric Asthma Caregiver's Quality of Life Questionnaire) will be evaluated at baseline, 3 months, and 6 months. We will also evaluate acceptability, feasibility, and fidelity of the intervention using mixed methods approaches.DiscussionThe long-term goal of this study is to disseminate locally appropriate asthma management strategies in LMIC settings. This study will contribute to the body of knowledge surrounding approaches for developing and evaluating intervention strategies for asthma using systematic, theory-based approaches grounded in local context. Such strategies have the potential to inform the development and adaptation of appropriate and scalable solutions for asthma management in LMIC settings.Trial registrationClinicalTrials.gov, NCT03986177. Registered on 14 June 2019.

Project description:BackgroundWe know that parents require resources which can assist them to improve fever knowledge and management practices. The purpose of this study, using an RCT, was to examine the effectiveness of an information leaflet at increasing parental knowledge of fever, specifically temperature definition.MethodsA prospective, multi-centre, randomised, two-parallel arm, controlled trial with blinded outcome ascertainment was conducted. Parents presenting at purposively selected healthcare facilities who had a child aged ≤5 years of age were invited to participate. An information leaflet for use in the trial was designed based on previous studies with parents. Parents in the intervention arm read an information leaflet on fever and management of fever in children, completed a short questionnaire at Time 1 (T1) and again 2 weeks after randomisation at Time 2 (T2). Parents in the control arm did not receive the fever information leaflet but completed the same questionnaire as the intervention arm at T1 and againat T2. The primary outcome was the correct definition of fever (higher than ≥38 °C).ResultsA total of 100 parents participated in the study at T1. A greater proportion of the intervention group (76%) than the control group (28%) selected the correct temperature (≥38 °C) at T1. 76% of the intervention arm correctly identified "higher than ≥38°C" as the temperature at which a fever is said to be present compared to 28% of the control arm. After 2 weeks, there was an increase of 6% of parents in the intervention arm (increase to 82.4%) who gave the correct temperature compared to just a 2.8% increase in the control arm (increase to 30.8%). Univariate logistic regression showed that parents in the intervention arm were significantly more likely to give the correct answer at both time-points (T1: OR 8.1; CI 95% 3.3-19.9: p < 0.01; T2: OR 10.5; CI 95% 3.4-32.0: p < 0.01).ConclusionsOur RCT of this simple educational intervention has been shown to improve parental understanding of fever knowledge and correct management strategies. Education interventions providing simple, clear information is a key step to decreasing parental mismanagement of fever and febrile illness in children.Trial registrationClinicalTrials.gov NCT02903342, September 16, 2016, Retrospectively registered.

Project description:BackgroundType 2 diabetes mellitus (T2DM) has increased globally; with a disproportionate burden in South and Southeast Asian countries, including Nepal. There is an urgent need for clinically and cost-effective culturally adapted T2DM management programs. In this study, we aim to assess the effectiveness of community based culturally appropriate lifestyle intervention in improving the management and care of people with T2DM.MethodsWe will conduct a cluster randomized control trial to evaluate the effectiveness of community based culturally appropriate lifestyle intervention in improving T2DM outcomes. The trial will be conducted in 30 randomly selected healthcare facilities from two purposively selected districts (Kavrepalanchowk and Nuwakot districts) of Bagmati province, Nepal. The selected healthcare facilities are being randomized into 15 interventions (n = 15) and usual care (n = 15) groups. Those in the intervention will receive group-based 12 an hour-long fortnightly session delivered over 6 months period. The intervention package includes 12 planned modules related to diabetes care, ongoing support, supervision and monitoring, follow-up from the trained community health workers, and educational materials on diabetes self-management. The participants in the usual care groups will receive pictorial brochure on diabetes management and they will continue receiving the usual care available from the local health facilities. The primary outcome is HbA1c level, and the secondary outcomes include quality of life, health care utilization, and practice of self-care behaviour, depression, oral health quality of life, and economic assessment of the intervention. Two points measurements will be collected by the trained research assistants at baseline and at the end of the intervention.DiscussionThis study will provide tested approaches for culturally adapting T2DM interventions in the Nepalese context. The findings will also have practice and policy implications for T2DM prevention and management in Nepal.Trial registrationAustralia and New Zealand Clinical Trial Registry (ACTRN12621000531819). Registered on May 6, 2021.

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Clustered randomised trial of an intervention to improve the management of asthma: Greenwich asthma study.

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Clustered randomised trial of an intervention to improve the management of asthma: Greenwich asthma study.

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