Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
10/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marion Drietelaar

ORCID ID

Contact details

Onderzoeksinstituut Caphri
Universiteit van Maastricht
Postbus 616
Maastricht
6200 MD
Netherlands
+31 (0)43 388 2272
Marion.Drietelaar@HAG.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Internal budget number 30.95.01.04.b

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Asthma, chronic obstructive pulmonary disease (COPD)

Intervention

The intervention in the trial was the diagnostic and therapeutic advice offered to the general practitioners by the Asthma/COPD-service in Eindhoven. These advices are a new but already introduced facility for general practitioners and their patients. This facility is in the process of implementation. General practitioners in the research project who, after randomisation, are eligible to first use the facility are considered to be the intervention group (N=17). General practitioners who don’t get the full support of the Asthma/COPD-service yet (N=17) are considered to be the control group.

Each general practice participates in the research project for two years. In this period the patients of the intervention group receive two yearly follow-up consultations at the Asthma/COPD service, on request of their general practitioner. Medical history and spirometry is performed. A lung specialist assesses by protocol the written results of these measurements and sends a structured report to the general practitioner. This report includes a diagnosis or an advice for further diagnostic examinations, and advices for treatment.

In the control group the general practitioners can have spirometry performed for their patients in the way they are used to. However, they don’t get the full report of the Asthma/COPD-service, only the description of the lung function.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Do general practitioners assess better diagnoses, according tot the NHG-standards, in Asthma/COPD-patients: do more patients have a correct diagnosis, do less patients have a wrong or incomplete diagnosis or no diagnosis at all?
2. Do general practitioners give their patients a better treatment, according to the NHG-standards: do more patients get the right medication, do less patients get wrong or unnecessary medication. Do patients receive more information about their disease and about self management?
3. Do patients have a better compliance, do they better follow the advices about stop smoking, exercise, do they have fewer complaints and a better quality of life?

Secondary outcome measures

1. Validity and reliability of the assessment and the reports of the Asthma/COPD-service
2. Epidemiological data about the prevalence of Asthma/COPD in general practices, the (incorrect) use of medication of in general practice
3. Costs of a support as given by the Asthma/COPD-service, related to the diagnostic and therapeutic gain in patient care

Overall trial start date

01/01/2003

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All general practices in and around the city of Eindhoven could be included as long as they used the facilities of the Diagnostic Centre, which the Asthma/COPD-service is a part of. Although they should not have any experience with the support of the Asthma/COPD-service. They were also excluded in case they had employed a "praktijkondersteuner" (specialised nurse or assistant) for the Asthma/COPD disease management.

In the intervention as well as in the control practices, all patients 12 years and older that have airway complaints could participate as long as they were not treated by a lung specialist.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

1000

Participant exclusion criteria

See inclusion criteria.

Recruitment start date

01/01/2003

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Onderzoeksinstituut Caphri
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

Care and Public Health Research Institute (CAPHRI) (The Netherlands)

Sponsor details

University Maastricht
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 388 2446
e.habets@caphri.unimaas.nl

Sponsor type

Research organisation

Website

http://www.caphri.nl/

Funders

Funder type

Research organisation

Funder name

Partners in Care Solutions (PICASSO) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes