Educational Intervention for Managing Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
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Brief Summary
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Given the importance of the correct use of inhalers by patients with Chronic Obstructive Pulmonary Disease (COPD) for the appropriate treatment of the disease, the self-care programme which will be assessed will consist of an educational intervention on the correct use of inhalers. For this aim, we have designed this study to assess the influence of both individualized and collective self care programmes about the correct use of inhalers improves the functional state of patients with COPD compared to when there is no educational intervention.

Detailed Description
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One of the key aspects for treating COPD is therapy with inhalation devices. Regarding the correct use of these devices, the international evidence showing that inhalers are not properly used, and in Spain, to the point that the inhaled therapy will fail if it is not accompanied by health education. More recent studies touch upon the importance of nurses, physicians and other medical staff teaching the correct use of the inhaler. Apart from education, other factors play an important role when it comes to using the inhaler correctly: sex, age, level of education, polymedicated patients who use several kinds of devices, patients who are not aware of their disease and, finally, what is called therapeutic non-fulfillment. The first report of the effectiveness of a self care programme aimed at the acquisition of self care abilities and behavior change was by Worth. Unfortunately this pilot study was not controlled and only studied a small sample of patients with COPD. There were impressive reductions in the frequency of irritations and house visits by the GP, but no changes in pulmonary function were found. Several clinical trials have been carried out to evaluate the effectiveness of education programmes and self care in COPD. In the Cochrane revision (up-date 2007), no conclusions could be drawn about the effectiveness of self-control due to the great diversity of variables measured in the few studies published. Based on the antecedents presented, it is evident that COPD is a disease which is difficult to control in daily clinical practice, and that this inadequate control has a significant impact not only on the health of the patient who has this disease, but also on society and the economy. To improve the control of COPD, the Primary Care physician needs simple and fast intervention to allow him or her to objectively improve the level of control of the disease that these patients have. The objective of self care is to teach patients the necessary aptitudes to carry out specific medical regimes for the treatment of COPD, to guide patients in how to have healthy habits and to lend emotional support to patients to help control their disease

Official Title
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Effectiveness of an Educational Intervention for Managing Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Patients in Primary Care: A Randomized Clinical Trial

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: education intervention


Participation Criteria
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Eligibility Criteria
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The inclusion criteria: A patient diagnosed with COPD undergoing chronic treatment with at least one inhaler in the last year. The criteria of having been prescribed at least 10 prescriptions for an inhaler in the year will be used. Age between 40 to 75 years. And exclusion criteria: Asthma diagnosis, Serious or terminal illnesses, Limiting osteoarticular disease, Walking disability, Serious mental illnesses: Psychosis, Major depressive disorder, Neurosis, Addictions to drugs/alcohol, Displaced patients (not habitual residents), Pregnancy.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: without health education<br>the normal practices without specific intervention | |
| Experimental: individual health education<br>The study intervention is an individual education in the correct use of inhalers and it will be carried out in so-called inhalation workshops. The room in which the inhalation workshop will be located has to meet the necessary comfort conditions for the patient to feel relaxed and be able to carry out learning. The lesson included inhalation devices, explanatory leaflets | Behavioral: education intervention<br>* Individual or collective education interventions about the correct use of inhalers. session in the management of inhalers in the collective or individual programmed. Session individual: 2 session. 15 min for session. Session collective: 2 session. 30-40 min for session. Maximum 4 persons.<br>|
| Experimental: health education group<br>The study intervention is education in group in the correct use of inhalers and it will be carried out in so-called inhalation workshops. The room in which the inhalation workshop will be located has to meet the necessary comfort conditions for the patient to feel relaxed and be able to carry out learning. In addition to the necessary furniture and teaching material that will be required (slide projector, over-head-projector, projection screen, video, etc.), the physical space given over to this purpose should consist of an area in which material can be left which will be used to complete the teaching and patient information (inhalation devices, explanatory leaflets, small monographs, slides, etc.). | Behavioral: education intervention<br>* Individual or collective education interventions about the correct use of inhalers. session in the management of inhalers in the collective or individual programmed. Session individual: 2 session. 15 min for session. Session collective: 2 session. 30-40 min for session. Maximum 4 persons.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyze if there is an improvement in the Score of BODE test | The score is obtained by adding the points together (0-3) for each of the following four variables: distance covered in the 6 minute walking test, forced expiratory volume in the first second in the forced spirometry test, score on the MRC dyspnea test and body mass index | 15 days, 30 days, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walking test |  | 15 days, 30 days, 6 months | 
| Medical Research Council Scale (MRC) to measure the level of dyspnea (Bestall y col). |  | 15 days, 30 days, 6 months | 
| Number of recurrences |  | 15 days, 30 days, 6 months | 
| Number of hospitalisations |  | 15 days, 30 days, 6 months | 
| Visual assessment scales of the use of inhalers |  | 15 days, 30 days, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inhalators, Education, Primary care