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The Use of a Forecasting System for Predicting Exacerbations of COPD

NCT ID: NCT00788645

Last Updated: 2010-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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Smoking COPD Chronic Obstructive Lung Disease COPD Exacerbations Viruses and Bacteria associated with COPD exacerbations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Forecast

COPD patients receiving advice and poor weather warning

Group Type EXPERIMENTAL

COPD self care advice

Intervention Type BEHAVIORAL

Information leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room

Poor weather forecast warning

Intervention Type BEHAVIORAL

Interactive automated telephone service to contact patients prior to anticipated periods of poor weather

No Forecast

COPD patients receiving advice and poor weather warning

Group Type EXPERIMENTAL

COPD self care advice

Intervention Type BEHAVIORAL

Information leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room

Control

Age matched non - COPD subjects

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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COPD self care advice

Information leaflets on COPD and thermometers to monitor the ambient temperature in the bedroom and living room

Intervention Type BEHAVIORAL

Poor weather forecast warning

Interactive automated telephone service to contact patients prior to anticipated periods of poor weather

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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David Halpin, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Devon and Exeter Hospital, Exeter, Devon, UK

Locations

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Research Site

Exeter, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Halpin DM, Laing-Morton T, Spedding S, Levy ML, Coyle P, Lewis J, Newbold P, Marno P. A randomised controlled trial of the effect of automated interactive calling combined with a health risk forecast on frequency and severity of exacerbations of COPD assessed clinically and using EXACT PRO. Prim Care Respir J. 2011 Sep;20(3):324-31, 2 p following 331. doi: 10.4104/pcrj.2011.00057.

Reference Type DERIVED
PMID: 21687919 (View on PubMed)

Other Identifiers

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D6256M00017

Identifier Type: -

Identifier Source: org_study_id