Condition category
Respiratory
Date applied
06/07/2011
Date assigned
04/08/2011
Last edited
11/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
An inhaler is a device holding a medicine that you take by breathing in (inhaling). The delivery of drugs through inhalers has revolutionized the treatment of patients with respiratory (lung) diseases. The effectiveness of inhaled drugs can be influenced by many factors including age, sex, educational level, duration of the disease, type of inhaler, a correct technique or the use of multiple devices. Misuse of inhalers is a significant problem both for asthma and chronic obstructive pulmonary disease (COPD) because the consequence is a decrease in the effect of the drugs, causing a worse control of symptoms and therefore no effective control of the disease. The aim of this study is to evaluate the effectiveness of two educational interventions to improve the technique of drug inhalation in patients with COPD.

Who can participate?
Patients aged over 18 diagnosed with COPD who use inhaled therapy.

What does the study involve?
Participants are randomly allocated into three groups. The first group receives a leaflet about the correct inhalation technique. The second group receives the same leaflet and also instructor training about the correct inhalation technique. The third group receives treatment as usual. All participants attend follow-up appointments 3, 6 and 12 months later. The appointments are about 20 - 30 minutes long, depending on the group.

What are the possible benefits and risks of participating?
There are no risks for the participants

Where is the study run from?
Primary care centres in Málaga (Spain)

When is the study starting and how long is it expected to run for?
March 2011 to December 2013

Who is funding the study?
Instituto de Salud Carlos III (Ministerio de Ciencia e Innovación, Gobierno de España) (Spain)

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr José Leiva Fernandez

ORCID ID

Contact details

Unidad Docente Medicina Familiar y Comunitaria
Distrito Sanitario Málaga
Plaza Hospital Civil s/n Pabellón 6 2ª planta
Málaga
29009
Spain
+34 (0)951 290 310
mariap.barnestein.exts@juntadeandalucia.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI10/02384

Study information

Scientific title

Efficacy of two educational interventions about inhalation technique in patients with Chronic Obstructive Pulmonary Disease (COPD) - a randomized controlled trial

Acronym

TIEPOC

Study hypothesis

The application of two educational interventions in patients with COPD who use inhaled therapy will increase the number of patients who perform a correct inhalation technique by at least 25%

Ethics approval

1. Ethical Committees of Distrito Sanitario Málaga, 21/12/2010
2. Área Sanitaria Málaga Este-Axarquía, 16/02/2010
3. Autonomic Clinical Assays Committee, 25/01/2011

Study design

Multicenter randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Chronic obstructive pulmonary disease

Intervention

The study is divided into three arms by block randomization: control, intervention A and intervention B:
1. Intervention A: written information
1.1. We will give written information about inhalation technique to the patient
1.2. We will design a leaflet about the correct inhalation technique, containing the main devices that patients use in our area
2. Intervention B: written information about inhalation technique and instructor training
2.1. We will give written information about inhalation technique to the patient (leaflet described above) and we are going to train the patient about the correct inhalation technique
3. Control group: treatment as usual
4. The appointments are approximately 20 - 30 minutes, depending on the arm of study
5. When the participant been located in an intervention arm the visit will be more detailed
6. The follow-up is the same for all arms and will be for 12 months

Visit schedule:
Intervention Group A and B:
Visit of inclusion: all the study data will be recorded and the inhalator technique will be tested
Visit 1: It will take place 3 months after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured and encouraging work about inhalers techniques and motivational aspects related with this will be individually applied.
Visit 2: It will take place 6 months after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured and encouraging work about inhalers techniques and motivational aspects related with this will be individually applied.
Visit 3: I will take place 12 months after the intervention. All the study data will be recorded and encouraging work about inhalers techniques and motivational aspects related with this will be individually applied.
Control Group:
Visit of inclusion: all the study data will be recorded and the inhalator technique will be tested.
Visit 1: It will take place 3 months after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured.
Visit 2: It will take place 6 months after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured.
Visit 3: I will take place 12 months after the intervention. All the study data will be recorded.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Performance of correct inhalation technique
2. The correct inhalation technique will be measured by an investigator following SEPAR guidelines

Secondary outcome measures

1. Pick flow measured at all visits
2. Dyspnea (Baseline dyspnea index (IDB) and Modified Medical Research Council (MMRC) questionnaires), measured at all visits
3. Functional status (spirometry), measured at visit of inclusion, visit 2 and visit 4.
4. Quality of life (St George and SeguiEPOC questionnaires), measured at visit of inclusion, visit 2 and visit 4

Overall trial start date

15/03/2011

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed COPD diagnosis by spirometry (SEPAR guidelines)
2. Belonging to the selected Primary Care Centers in Malaga area
3. Use of inhaled therapy
4. Accepted to participate in the study and given informed consent
5. Aged over 18 years
6. Male or female participants

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

296

Participant exclusion criteria

1. Diagnosis of other respiratory conditions which are not included in the COPD definition
2. Cognitive impairment problems

Recruitment start date

15/09/2011

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Spain

Trial participating centre

Unidad Docente Medicina Familiar y Comunitaria
Málaga
29009
Spain

Sponsor information

Organisation

Instituto de Salud (Instituto de Salud Carlos III, MInisterio de Ciencia e Innovación) (Spain)

Sponsor details

Sinesio Delgado nº 6
Madrid
28029
Spain
+34 (0)918 222 100
oficina.informacion@isciii.es

Sponsor type

Government

Website

http://www.isciii.es

Funders

Funder type

Government

Funder name

Instituto de Salud (Instituto de Salud Carlos III, MInisterio de Ciencia e Innovación) (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

Publication citations

Additional files

Editorial Notes

11/02/2016: Plain English summary added.