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Childhood Asthma Management in Primary Care: Implementation Of Exhaled Nitric Oxide and Spirometry Testing
trial in Asthma in 613 participants. Completed in 1 September 2017.
| Lead sponsor | University of Leicester |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 613 |
| Start date | 1 June 2016 |
| Primary completion | 1 September 2017 |
| Estimated completion | 1 September 2017 |
| Sites | 2 locations across United Kingdom |
University of Leicester
Adults 5 to 16, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time (minutes) to perform both spirometry and eNO test in children
| Group | Value | 95% CI |
|---|---|---|
| Study Cohort | 4.3 | ± 1.3 |
| Group | Value | 95% CI |
|---|---|---|
| Study Cohort | 3.1 | ± 1.0 |
| Group | Value | 95% CI |
|---|---|---|
| Study Cohort | 2.4 | ± 1.0 |
Number of children (out of 612) able to perform objective tests
| Group | Value | 95% CI |
|---|---|---|
| Study Cohort | 575 |
Number of children in whom an asthma diagnosis could be confirmed on objective testing
| Group | Value | 95% CI |
|---|---|---|
| Study Cohort | 13 |
Timepoints - Assessed at enrolment and at 3-6 months post enrolment Purpose: The Paediatric Asthma Quality of Life Questionnaire (PAQLQ) was developed to measure the functional problems (physical, emotional and social) that are most troublesome to children with asthma. Format: The PAQLQ can be administered by an interviewer or self-administered by the child Content: The PAQLQ contains 23 questions that cover three domains: activity limitation, symptoms, and emotional function Scoring: Children are asked to think about how they have been during the previous week and to respond to each of the 3
| Group | Value | 95% CI |
|---|---|---|
| Study Cohort | 5.92 | ± 1.06 |
| Group | Value | 95% CI |
|---|---|---|
| Study Cohort | 6.02 | ± 1.04 |
Timepoints - measured at enrolment and at 3-6 months post-enrolment Purpose: The CHU9D is a paediatric generic preference based measure of health related quality of life. It consists of a descriptive system and a set of preference weights, giving utility values for each health state described by the descriptive system, allowing the calculation of quality adjusted life years (QALYs) for use in cost utility analysis. Format: Consists of nine dimensions of health-related quality of life, including worry, sadness, pain, tiredness, annoyance, school, sleep, daily routine, and activities. The child
| Group | Value | 95% CI |
|---|---|---|
| Study Cohort | 0.88 | ± 0.16 |
| Group | Value | 95% CI |
|---|---|---|
| Study Cohort | 0.85 | ± 0.18 |
Based on responses to a questionnaire administered at the end of their training using pre-determined responses along a 5-point likert scale.
| Group | Value | 95% CI |
|---|---|---|
| Primary Care Healthcare Professionals | 23 |
Based on responses to a questionnaire administered at the end of their asthma review using pre-determined responses along a 5-point likert scale.
| Group | Value | 95% CI |
|---|---|---|
| Study Cohort | 537 |
What are the capacity and training needs in general practice to implement routine spirometry and eNO testing in children aged 5-16 years? Asthma is the commonest long-term disease of childhood in the United Kingdom (UK). Under-diagnosis and under-treatment of childhood asthma in general practice (GP) have been reported from several European countries including the UK. This can result in poor symptom control and increased risk of asthma related deaths. It has been suggested that both under- and over- diagnosis of childhood asthma in general practice could be improved by routinely using objective lung function testing for diagnosis and monitoring. The proposed objective lung function tests (spirometry and exhaled nitric oxide measurements - eNO) are already used routinely in UK hospitals, but are not usually available in general practice where most children are cared for. Why is it important? - Availability of these tests will help health professionals in general practice to look after children with asthma better, and hopefully improve asthma control. What will this study achieve? - Though it is believed that providing spirometry and eNO in general practice would be beneficial, there is little data on how this can be achieved. This study will employ both qualitative and quantitative measures in order to evaluate the resources required to implement routine spirometry and eNO testing for children in primary care; and to investigate the impact this would have on diagnosis in children with suspected asthma. How? - The investigators will work with general practices in and around Leicestershire, UK. Firstly, to identify what the barriers are to implementing these tests, and secondly to train the practices to perform and interpret spirometry and eNO independently in children. Children with suspected or previously diagnosed asthma will be invited for review and lung function testing. The investigators will record the time it takes to train general practices to perform and interpret spirometry and eNO independently, and the additional clinic capacity required to provide these tests.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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