Condition category
Respiratory
Date applied
23/03/2010
Date assigned
28/04/2010
Last edited
19/05/2011
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 Francisca Leiva Fernández

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
+34 951 29 03 10
francisca.leiva.sspa@juntadeandalucia.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI-0492/09 and EC10-193

Study information

Scientific title

Efficacy of two educational interventions about inhalation technique in patients with chronic obstructive pulmonary disease (COPD): a preference study

Acronym

TECEPOC

Study hypothesis

The application of two educational interventions in patients with chronic obstructive pulmonary disease (COPD) with inhaled therapy is going to improve in at least 25% the patients who perform a correct inhalation technique.

Please note, as of 19/05/2011 a continuation of this trial has been implemented. The modifications to the trial can be found under the date of update in the relevant sections below. The anticipated end date has therefore been extended from 31/12/2011 to 30/06/2013.

Ethics approval

1. Ethical Committee of Distrito Sanitario Málaga approved on the 1st March 2007
2. Ethical Committee of Distrito Sanitario Axarquía approved on the 13th May 2008

Study design

Multicentre patients' preference trial or comprehensive cohort design

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 (COPD)

Intervention

Current interventions (as of 19/05/2011)
The study is divided into two groups and five arms. The two groups are:
1. The patients' preferences group (two arms)
2. The randomised group (three arms)

In the preferences group, the two arms correspond to the two educational interventions designed for this study. In the randomised group, the three arms are as follows:

Intervention A: Written information -
We will give written information about inhalation technique to the patient. We will design a leaflet about the correct inhalation technique, containing the main devices the patients use in our area.

Intervention B: Written information about inhalation technique and instructor training -
We will give written information about inhalation technique to the patient (leaflet described above) and we are going to train the patient about correct inhalation technique.

Control group:
Treatment as usual.

The appointments are approximately 20 - 30 minutes, depending on the arm of study. When the participant been located in an intervention arm the visit will be more detailed. 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 1 month 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: I will take place 3 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.
Visit 3: 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 4: 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 1 month after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured.
Visit 2: I will take place 3 months after the intervention. All the study data will be recorded.
Visit 3: It will take place 6 month after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured.
Visit 4: I will take place 12 months after the intervention. All the study data will be recorded.

Previous interventions:
The study is divided into two groups and five arms. The two groups are:
1. The patients' preferences group (two arms)
2. The randomised group (three arms)

In the preferences group, the two arms correspond to the two educational interventions designed for this study. In the randomised group, the three arms are as follows:

Intervention A: Written information -
We will give written information about inhalation technique to the patient. We will design a leaflet about the correct inhalation technique, containing the main devices the patients use in our area.

Intervention B: Written information about inhalation technique and instructor training -
We will give written information about inhalation technique to the patient (leaflet described above) and we are going to train the patient about correct inhalation technique.

Control group:
Treatment as usual.

The appointments are approximately 20 - 30 minutes, depending on the arm of study. When the participant been located in an intervention arm the visit will be more detailed. The follow-up is the same for all arms and will be for 3 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 1 month 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: I will take place 3 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 1 month after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured.
Visit 2: I will take place 3 months after the intervention. All the study data will be recorded.

Secondary Sponsor Details:
Dirección General de Farmacia y Productos Sanitarios de Ministerio de Sanidad, Política Social e Igualdad. (Spain)
Paseo del Prado 18-20
Madrid
28014
Spain
+34 915961000
+34 915964480
oiac@mspsi.es
http://www.msps.es

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Performance of correct inhalation technique. The correct inhalation technique will be measured by an investigator following SEPAR guidelines. Measured at all visits

Secondary outcome measures

Current secondary outcomes measures (as of 19/05/2011):

1. Pick flow, measured at all visits
2. Dyspnoea (Baseline Dyspnoea 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, measured with the Spanish version of the St George's Respiratory Questionnaire and the specifically created SeguiEPOC Questionnaire, measured at visit of inclusion, visit 2 and visit 4.

Previous secondary outcome measures:

1. Pick flow, measured at all visits
2. Dyspnoea (Baseline Dyspnoea Index [IDB] and Modified Medical Research Council [MMRC] questionnaires), measured at all visits
3. Functional status (spirometry), measured at visit of inclusion and visit 2
4. Quality of life, measured with the Spanish version of the St George's Respiratory Questionnaire and the specifically created SeguiEPOC Questionnaire, measured at visit of inclusion and visit 2

Overall trial start date

15/03/2010

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed COPD diagnose by spirometry (Spanish Society of Pulmonology and Thoracic Surgery [SEPAR] guidelines)
2. Belonging to the selected Primary Care Centres in Malaga area
3. Use of inhalatory therapy
4. Accepted to participate in the study and gives informed consent
5. Aged greater than or equal to 18 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

495

Participant exclusion criteria

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

Recruitment start date

15/03/2010

Recruitment end date

30/06/2013

Locations

Countries of recruitment

Spain

Trial participating centre

Unidad Docente Medicina Familiar y Comunitaria
Málaga
29009
Spain

Sponsor information

Organisation

Council of Andalusian Health Services (Consejería de Salud, Junta de Andalucia) (Spain)

Sponsor details

Avd de la Innovación s/n. Edificio Arena 1
Sevilla
41020
Spain
+34 955 00 63 00
fundacion.progreso.salud@juntadeandalucia.es

Sponsor type

Government

Website

http://www.juntadeandalucia.es/index.html

Funders

Funder type

Government

Funder name

Council of Andalusian Health Services (Consejería 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

Publication citations

Additional files

Editorial Notes