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
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