Educational intervention to improve the inhalation technique in patients with chronic obstructive pulmonary disease
| ISRCTN | ISRCTN60147249 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60147249 |
| Secondary identifying numbers | PI10/02384 |
- Submission date
- 06/07/2011
- Registration date
- 04/08/2011
- Last edited
- 11/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
Unidad Docente Medicina Familiar y Comunitaria
Distrito Sanitario Málaga
Plaza Hospital Civil s/n Pabellón 6 2ª planta
Málaga
29009
Spain
| Phone | +34 (0)951 290 310 |
|---|---|
| mariap.barnestein.exts@juntadeandalucia.es |
Study information
| Study design | Multicenter randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy of two educational interventions about inhalation technique in patients with Chronic Obstructive Pulmonary Disease (COPD) - a randomized controlled trial |
| Study acronym | TIEPOC |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/03/2011 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 296 |
| Key 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 |
| Key exclusion criteria | 1. Diagnosis of other respiratory conditions which are not included in the COPD definition 2. Cognitive impairment problems |
| Date of first enrolment | 15/09/2011 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Spain
Study participating centre
29009
Spain
Sponsor information
Government
Sinesio Delgado nº 6
Madrid
28029
Spain
| Phone | +34 (0)918 222 100 |
|---|---|
| oficina.informacion@isciii.es | |
| Website | http://www.isciii.es |
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
11/02/2016: Plain English summary added.
