The Use of a Forecasting System for Predicting Exacerbations of COPD

Study Overview
=================
Brief Summary
-----------------
People with Chronic Obstructive Pulmonary Disease (COPD) often have periods during the year when their symptoms become worse. These are often due to an infection and are called exacerbations by doctors. Exacerbations are more common in the winter and also seem to be related to particular types of weather. As well as forecasting the weather the UK Met Office has developed a system to try to predict when exacerbations are likely to occur. The main purpose of this research study is to find out whether the Met Office forecasting service can predict when exacerbations are more likely to occur and whether the advice given during the predicted higher risk periods leads to fewer patients having an exacerbation or if it reduces the impact of the exacerbation. The study will also assess if there is a link between viral or bacterial infection and breathing problems that occur during the study period. The study will also collect information about possible causes of the breathing problems and what happens to the person afterwards. The results of this study will help us learn more about breathing problems which may lead to new research studies that would aim to improve the care of people with COPD.

Official Title
-----------------
The Use of a Forecasting System for Predicting Exacerbations of COPD: Effect on Symptoms and Hospitalisation and Relevance of Viral Infections

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Behavioral: COPD self care advice
* Behavioral: Poor weather forecast warning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current or former smokers with a diagnosis of COPD Having impaired lung function as measured by spirometry Exclusion Criteria: History of asthma or nasal symptoms caused by hayfever No telephone Inability to record symptoms in an electronic diary (PDA)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Forecast<br>COPD patients receiving advice and poor weather warning | Behavioral: COPD self care advice<br>* Information leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room<br>Behavioral: Poor weather forecast warning<br>* Interactive automated telephone service to contact patients prior to anticipated periods of poor weather<br>|
| Experimental: No Forecast<br>COPD patients receiving advice and poor weather warning | Behavioral: COPD self care advice<br>* Information leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room<br>|
| No Intervention: Control<br>Age matched non - COPD subjects | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and frequency of COPD exacerbations in each of the intervention groups |  | December 2008 to March 2009 inclusive | 
| Electronic diary symptoms using the EXACT instrument |  | Daily recording | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication usage and hospital admissions |  | Acutely | 
| Changes in the St Georges Respiratory questionaire |  | Start and end of study period | 
| Severity and duration of exacerbations assessed using the EXACT instrument |  | Daily recording | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking, COPD, Chronic Obstructive Lung Disease, COPD Exacerbations, Viruses and Bacteria associated with COPD exacerbations