Educational Intervention for Managing Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Patients
Effectiveness of an Educational Intervention for Managing Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Patients in Primary Care: A Randomized Clinical Trial
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Region De Murcia
-
Murcia, Region De Murcia, Španělsko, 30003
- Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: without health education
the normal practices without specific intervention
|
|
|
Experimentální: individual health education
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
|
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. |
|
Experimentální: health education group
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.).
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
To analyze if there is an improvement in the Score of BODE test
Časové okno: 15 days, 30 days, 6 months
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Six minute walking test
Časové okno: 15 days, 30 days, 6 months
|
15 days, 30 days, 6 months
|
|
Medical Research Council Scale (MRC) to measure the level of dyspnea (Bestall y col).
Časové okno: 15 days, 30 days, 6 months
|
15 days, 30 days, 6 months
|
|
Number of recurrences
Časové okno: 15 days, 30 days, 6 months
|
15 days, 30 days, 6 months
|
|
Number of hospitalisations
Časové okno: 15 days, 30 days, 6 months
|
15 days, 30 days, 6 months
|
|
Visual assessment scales of the use of inhalers
Časové okno: 15 days, 30 days, 6 months
|
15 days, 30 days, 6 months
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: A Lopez-santiago, MD, Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.
Publikace a užitečné odkazy
Obecné publikace
- Peces-Barba G, Barbera JA, Agusti A, Casanova C, Casas A, Izquierdo JL, Jardim J, Lopez Varela V, Monso E, Montemayor T, Viejo JL. [Diagnosis and management of chronic obstructive pulmonary disease: joint guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Latin American Thoracic Society (ALAT)]. Arch Bronconeumol. 2008 May;44(5):271-81. No abstract available. Spanish.
- Annesi- Maesano I. Epidemiology of chronic obstructive pulmonary disease. In: Siafakas NM, ed. Management of Chronic Obstructive Pulmonary Disease. 2006.
- Sobradillo V, Miravitlles M, Jimenez CA, Gabriel R, Viejo JL, Masa JF, Fernandez-Fau L, Villasante C. [Epidemiological study of chronic obstructive pulmonary disease in Spain (IBERPOC): prevalence of chronic respiratory symptoms and airflow limitation]. Arch Bronconeumol. 1999 Apr;35(4):159-66. doi: 10.1016/s0300-2896(15)30272-6. Spanish.
- Miravitlles M, Soriano JB, Garcia-Rio F, Munoz L, Duran-Tauleria E, Sanchez G, Sobradillo V, Ancochea J. Prevalence of COPD in Spain: impact of undiagnosed COPD on quality of life and daily life activities. Thorax. 2009 Oct;64(10):863-8. doi: 10.1136/thx.2009.115725. Epub 2009 Jun 23.
- Masa JF, Sobradillo V, Villasante C, Jimenez-Ruiz CA, Fernandez-Fau L, Viejo JL, Miravitlles M. [Costs of chronic obstructive pulmonary disease in Spain. Estimation from a population-based study]. Arch Bronconeumol. 2004 Feb;40(2):72-9. doi: 10.1016/s1579-2129(06)60198-5. Spanish.
- Instituto Nacional de Estadística INE. Encuesta Nacional de Salud 2006.
- Haupt D, Krigsman K, Nilsson JL. Medication persistence among patients with asthma/COPD drugs. Pharm World Sci. 2008 Oct;30(5):509-14. doi: 10.1007/s11096-008-9197-4. Epub 2008 Feb 5.
- Jung E, Pickard AS, Salmon JW, Bartle B, Lee TA. Medication adherence and persistence in the last year of life in COPD patients. Respir Med. 2009 Apr;103(4):525-34. doi: 10.1016/j.rmed.2008.11.004. Epub 2009 Jan 12.
- Burgos F. [Inhalation therapy without instruction: failure foreseen]. Arch Bronconeumol. 2002 Jul;38(7):297-9. doi: 10.1016/s0300-2896(02)75221-6. No abstract available. Spanish.
- Flor Escriche X, Rodriguez Mas M, Gallego Alvarez L, Alvarez Luque I, Juvanteny Gorgals J, Fraga Martinez MM, Sanchez Pinacho L. [Do our asthma patients still use inhalers incorrectly?]. Aten Primaria. 2003 Sep 30;32(5):269-74. doi: 10.1016/s0212-6567(03)79273-7. Spanish.
- Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.
- Worth H. Self management in COPD: one step beyond? Patient Educ Couns. 1997 Dec;32(1 Suppl):S105-9. doi: 10.1016/s0738-3991(97)00102-x.
- Effing T, Monninkhof EM, van der Valk PD, van der Palen J, van Herwaarden CL, Partidge MR, Walters EH, Zielhuis GA. Self-management education for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD002990. doi: 10.1002/14651858.CD002990.pub2.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BRISA II. EPOC-Inhaladores
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na education intervention
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI); 3-C Institute for Social...Zápis na pozvánku
-
US Department of Veterans AffairsIndiana University School of MedicineDokončeno
-
Aveiro UniversityNeznámýBolest krkuPortugalsko
-
Selcuk UniversityDokončenoPraxe založená na důkazechKrocan
-
University of South FloridaNational Cancer Institute (NCI)StaženoDětská rakovinaSpojené státy
-
Scripps Whittier Diabetes InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); San... a další spolupracovníciDokončenoCukrovka typu 2Spojené státy
-
National Healthcare Group, SingaporeTan Tock Seng HospitalDokončenoDiabetičtí pacienti, gamifikace, diabetická výchovaSingapur
-
University of NottinghamDokončenoDiabetes mellitus, typ 2 | Zdravotní chováníJordán
-
Medical College of WisconsinAktivní, ne náborCukrovka typu 2Spojené státy
-
VA Office of Research and DevelopmentDokončeno