Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT04705233
Brief Summary:
The primary objective of this study is to determine if a sputum colour chart can aid patient self-management of COPD exacerbations, such that use of the chart is non-inferior to usual care with respect to hospital admissions. There are also a range of other secondary objectives as detailed in the secondary outcomes section. An integral pilot phase, economic evaluation and process evaluation are also included.
Detailed Description:
This study is a pragmatic, individually randomized trial, set in primary care, comparing usual care to the use of a sputum colour chart in patients at risk of hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD), with the hypothesis that use of a colour chart will be non-inferior to usual care with respect to hospital admission rate after 12 months of follow-up, this being the primary outcome measure. Use of a chart might reduce antibiotic use, and thus might also change patterns of antibiotic resistance long term, such that these are important secondary outcomes. There is an internal pilot phase, a detailed process evaluation and a cost-effectiveness study.
The trial protocol also includes three sub-studies: 1) using a daily electronic symptom diary capable of picking up symptom defined (but potentially unreported) AECOPD, since these are an important prognostic marker (section 3); 2) collecting sputum samples from patients to assess patterns of antibiotic resistance and 3) a qualitative study which will include staff (for example, healthcare staff delivering the intervention) and patients.
This trial uses a sputum colour chart as part of a self-management intervention that enables patients with COPD to determine whether they have an exacerbation, and whether this requires antibiotic treatment. The 5 point sputum colour chart, adapted from Bronkotest® is being used.
Study:
NCT04705233
Study Brief:
Protocol Section:
NCT04705233