Condition category
Respiratory
Date applied
08/07/2014
Date assigned
18/08/2014
Last edited
21/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Many patients with asthma or chronic obstructive pulmonary disease (COPD) do not use their inhalers correctly. This is of significant concern as it can lead to poorer control of symptoms and worsening of the condition. Health care professionals also often don’t know the correct technique and are therefore unable to teach their patients how to use their inhalers properly. The aim of this study is to see whether showing health care professionals the correct way to use an inhaler (via an educational intervention) results in their patients doing the same.

Who can participate?
Health care professionals from one of the Basic Health Care Units (BHU) taking part in the trial and with at least 30 COPD patients being treated with inhalers.

What does the study involve?
Each health care professional is randomly allocated into one of two groups. Those in group 1 (experimental group) are shown to use an inhaler by a researcher using a training protocol. They then teach their patients the technique they have been taught. Those in group 2 (the control group) are not shown how to use an inhaler by a researcher but instead treat their COPD patients as usual. The inhalation technique of each patient in both groups is then tested. The health care professionals are tested on their knowledge about COPD patients and their treatment, age, sex and their education.

What are the possible benefits and risks of participating?
We are testing an educational and non-invasive intervention that does not pose a risk to the participants. The patients in the experimental group may benefit from learning to use their inhaler properly.

Where is the study run from?
The study is run from a total of 20 BHU’s at 8 primary care centres in Málaga (Spain)

When is the study starting and how long is it expected to run for?
January 2014 to December 2016

Who is funding the study?
Ministry of Health and Social Welfare of the Government of Andalusia [Consejeria de Salud, Junta de Andalucia] (Spain)

Who is the main contact?
Dr Jose Leiva-Fernández
mariap.barnestein.exts@juntadeandalucia.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose Leiva-Fernández

ORCID ID

Contact details

Calle del Doctor Fernando Vivar 0
Vélez Málaga (Málaga)
29700
Spain
-
mariap.barnestein.exts@juntadeandalucia.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI-0170/13

Study information

Scientific title

A pragmatic cluster randomized controlled trial: PROF-EPOC Study. Efficacy of an educational intervention about inhalation techniques in health-care professionals.

Acronym

PROF-EPOC Study

Study hypothesis

The application of an educational intervention on health-care professionals in Primary Attention will increase in at least 25% the performance of a correct inhalation technique in COPD patients in regards of a control cohort.

Ethics approval

Ethical Committees of Málaga (CEI provincial de Málaga), 12/12/2013.

Study design

Pragmatic cluster randomized controlled trial.

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

COPD

Intervention

The cluster design (intervention) is based on two levels:
1. The higher or second level is represented by the BHU which have a health-care professional as the chief of the unit (over whom the educational intervention is conducted)
2. The lower or first level represented by the BHU patients which have accepted to participate and are going to receive the educational intervention from their general practitioner (GP). Each block will be form by 4 BHU among which the 2 study cohorts will be uniformly distributed.

Control group:
Cluster that complies with selection criteria but where the intervention is not applied.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Performance of correct inhalation technique by improving the knowledge of the health-care professionals. The correct inhalation technique will be measured by a researcher following the SEPAR guidelines.

Secondary outcome measures

1. Functional status (measured by forced spirometry)
2. Dyspnea index (measured by the basal dyspnea index (BDI))
3. Health-related quality of life (measured by the St. George Respiratory Questionnaire)

Timepoints for all outcome measures:
Study data will be recorded at initial visit and 1 year later, with the exception of the educational intervention for the first level intervention group, where the correct inhalation technique and a reminder of this occurs 3 and 6 months after initial intervention

Overall trial start date

01/01/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. For health-care professionals: having an allocated BHU during the period of the trial, with at least 30 patients included in the COPD Andalusian Health Service Guidelines (COPD PAI) with inhaled therapy and sign the informed consent
2. For patients: COPD diagnosis, being treated in Primary Care Centres included in the trial, having inhaled therapy prescribed and accepting to participate in the trial with a signed informed consent

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

267

Participant exclusion criteria

1. For health-care professionals: the negativity of health-care professionals’ chiefs to participate in the trial or that they have to leave the BHU during the trial.
2. For patients: having another respiratory process not included in the COPD definition and cognitive impairments which prevent them from responding in an adequate way the trials questionnaires and the educational intervention assimilation.

Recruitment start date

01/01/2014

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Spain

Trial participating centre

Calle del Doctor Fernando Vivar 0
Vélez Málaga (Málaga)
29700
Spain

Sponsor information

Organisation

Ministry of Health and Social Welfare of the Government of Andalusia [Consejeria de Salud, Junta de Andalucia] (Spain)

Sponsor details

Avenida de Hytasa nº 14
Sevilla
41071
Spain
+34 955006300
informacion@juntadeandalucia.es

Sponsor type

Government

Website

http://www.juntadeandalucia.es/salud/sites/csalud/portal/index.jsp

Funders

Funder type

Government

Funder name

Ministry of Health and Social Welfare of the Government of Andalusia [Consejeria de Salud, Junta de Andalucia] (Spain)

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

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26988095

Publication citations

Additional files

Editorial Notes

21/03/2016: Publication reference added.