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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list