Effect of a Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in People With Chronic Obstructive Pulmonary Disease(COPD). A Randomised Clinical Trial.
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

 
Title of the project:  
 
Effectiveness of a structured comprehensive intervention to favour self-management and to 
improve health-related quality in patients with chronic obstructive pulmonary disease (COPD) in 
primary care. A randomized controlled study 
 
Date: 29/3/2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
ABSTRACT 
Background: Chronic Obstructive Pulmonary Disease (COPD) is a problem of public health of great magnitude, 
increasing morbidity and mortality and of high cost both in health resource consumption and in loss of quality of life 
related to health (HRQL). The "comprehensive approach to this complex illness, promoting self-care, improves 
HRQL and the clinical situation of patients, as shown by several studies, but more studies are needed to corroborate 
these results in the" Primary Care Area " (PC), and to make clear recommendations about the most effective type of 
intervention. 
Hypothesis: In patients with moderate to severe COPD, a self-care structured intervention is more effective than the 
usual intervention on the main variables associated with the disease: HRQL, pulmonary function, exacerbations, 
hospital admissions, in the setting of PC in a follow-up of 6, 12 and 24 months 
Objectives: To evaluate the impact of a comprehensive intervention to promote self-care and improve HRQL in 
people with COPD in PC. 
Methods: Randomized clinical trial multicentre with and control group, carried out at PC centers of Barcelona. 
Determinations: specific questionnaires, standardized and validated, such as the St George's Respiratory for HRQL. 
fferences 
between groups and variance of repeated measures (ANOVA) will be used to evaluate the effect of the intervention. 
Expected results: Significant improvement in HRQL in patients with COPD attributable to the intervention 
performed. 
Applicability and Relevance: The intervention could be incorporated into regular clinical practice with standardized 
contents. 
STUDY PROTOCOL 
1. BACKGROUND 
Chronic Obstructive Pulmonary Disease (COPD) is characterized by a chronic progressive air flow limitation which 
is not reversible and mainly associated with tobacco smoke. It is an illness that can be prevented and treated, with 
systemic involvement and usually accompanied by comorbidity.(1-7) 
In recent years, COPD has been defined not only as a pulmonary obstructive disease but also as a disease with 
systemic repercussion, and phenotypes have been recognized depending on the clinical presentation. (1-9) 
COPD is a public health problem of great magnitude, with high morbidity and mortality and a high health cost. The 
condition is under-diagnosed and its prevalence is expected to continue to increase. (8-9) 
The study of global burden of the disease (Global Burden of Disease Study-GBD-) targeted globally,has detected an 
increase of people with COPD compared to 1990 of almost 120 million.(10) 

In Spain, the IBERPOC study reported a prevalence of COPD of 9.1% among the population aged 40-69 years, with 
a high level of underdiagnosis: 78.2%. The "EPI-SCAN study" estimates the prevalence in the population of 
between 40 and 79 years in 10.2% with a 73% underdiagnosis .(11) 
The mortality rate of COPD, according to the GBD of the WHO, went from the fourth place in 1990 to the third 
place in 2010.(10) In Spain, according to data from the Carlos III Health Institute, COPD is the fifth cause of 
mortality.(12) In Catalonia, according to data from the Department of Health 2009 COPD 
is the third cause of death.(13) 
COPD is associated with a high cost in both health resource consumption and a loss of quality of life related to 
health (HRQL).In Spain, according to the Ministry of Health and Consumption-2009, "the estimated direct, indirect 
and intangible costs of COPD are estimated at 750-1000 million euros / year. The average direct cost per patient is 
1,712-3,238 euros / year distributed between 40-45% hospital costs, 35-40% in drugs and 15-25% in diagnostic 
tests. (14) 
In Catalonia, according to the Catalan Health Service-2004, direct costs are estimated at 238.82 million euros / year. 
It originates 10-12% of the consultations in primary care, 10% of visits to pneumology and is the third cause of 
hospitalization (more than 12% of patients require patients a hospital admission every year and almost 25% of them 
an annual consultation. (15). 
Given the complexity of the disease, a multidimensional approach allowing an integrated approach to control 
symptoms, slow down progression and reduce the number of exacerbations, is needed , with the aim of improving 
the prognosis and quality of life of people affected Comprehensive care includes health education, rehabilitation, the 
promotion of self-care and the involvement of the patient in decision-making. (15) 
Comprehensive care, according to the Terminology of Chronicity (TC), involves the complete interpretation of the 
human being and incorporates the promotion, prevention, recovery and rehabilitation to guarantee the global 
management of the person's needs, taking into account the multidimensional assessment (physical, emotional, 
cognitive, functional, social, ecological, spiritual and ethical aspects). (16) 
Self-care is a term applied to educational programs aimed at acquiring the necessary skills to perform the specific 
therapeutic regime for the disease, guide the healthy behavioural change and provide emotional support to patients 
for the control of their illness and for living a functional life (17.18) 
According to the Cochrane (RS) systematic review on "Self-care education for patients with COPD" (08/2007): "In 
COPD the value of self-care education is still unclear / .../ data is not enough to make clear recommendations about 
the form and contents of the self-care education programs for patients with COPD. " (19) 
A new systematic Cochrane review (2014) concluded that interventions where self-care is promoted are associated 
with a better HRQL, a reduction in hospital admissions and an improvement in dyspnea scale, without finding 
significant differences in other parameters. However, the heterogeneity of the studies makes it difficult to make clear 
recommendations about the types of intervention in the self-care of COPD, and a review of the studies included 
demonstrates that there is little evidence within the scope of primary care. 
There is an obvious need to carry out more large randomized clinical trials with long-term follow-up, before more 
conclusions can be made. ( 20) 
The Catalonia Health Plan 2010-2015 already contemplated the need to implement structured clinical processes for 
COPD with guides and defined care routes, and reinforced the role of Primary Care in chronic care. It also 
emphasized the importance of strengthening patients’ self-responsibility: "especially from Primary Care, measures 
should be provided to raise awareness of patients and caregivers, taking into account self-care opportunities ". 
The new Health Plan of Catalonia 2016-2020 gives continuity to the previous one, emphasizing also the self-
responsibility and self-care of people to achieve greater autonomy, a higher degree of compliance and facilitate 
shared decision-making. One of the 11 goals and priorities of health, emphasizes the personalization of care in 

respiratory diseases: “By 2020 a model of personalized medicine for COPD will be implemented in Catalonia. (21) 

2. HYPOTHESIS AND OBJECTIVES 
Hypothesis: In patients with moderate to severe COPD, structured intervention in self-care is more effective than 
usual intervention in the main variables associated with the disease: quality of life, pulmonary function, 
exacerbations, hospital admissions, and primary care visits in a follow-up of 6, 12 and 24 months. 
Overall objectives: To evaluate the impact of a comprehensive intervention to promote self-care and to improve the 
quality of life in people with Chronic Obstructive Pulmonary Disease (COPD) in Primary Care (PC). 
Specific objectives: 1.- To describe the profile of patients with COPD in our area through the main 
sociodemographic characteristics (sex, age, level of studies), risk factors, COPD phenotypes, respiratory function, 
prognosis, pharmacological treatment, technique inhalation, exacerbations and hospital admissions, comorbidities, 
and quality of life. 
2.-To assess using a clinical trial the effectiveness of a self-care program on different dimensions of clinical 
importance in COPD (degree of dyspnoea, prognosis, number of exacerbations, number of hospital admissions, 
degree of anxiety and depression). 
3. METHODOLOGY 
Design: Multicentre randomized clinical trial 
Reference population: Patients with a diagnosis of moderate-severe COPD treated with inhaled bronchodilators. 
Study population: Patients with a diagnosis of moderate and / or severe COPD , with bronchodilator treatment in PC 
Centers, that meet the criteria for inclusion in the study. 
Inclusion criteria: Patients who have been visited at least once last year at the center with diagnosis of COPD (J44), 
with a moderate airflow limitation (FEV1 between 50% - 80%) or severe airflow limitation(FEV1 between 30 % - 
50%), treated with bronchodilators, and who accept to participate in the study. 
Exclusion criteria 
- Patients only receiving home attention (Z74) 
- Patients with mental disorders and / or severe mental disorders that do not allow following the sessions 
- Patients diagnosed with asthma, tuberculosis or other chronic respiratory diseases 
- Patients receiving chronic home oxygen therapy (OCD). 
- Patients with terminal disease. 
Sample size and sample procedure: Accepting an alpha risk of 0.05 and a beta risk lower than 0.2 in a bilateral 
contrast, 182 subjects in the first group and 182 in the second are need to detect a difference equal to or greater than 
3.51 Units in the St George's Respiratory Questionnaire. It is assumed that the common standard deviation is 11.33. 
A follow-up loss of 10% has been estimated. Patients will be contacted by phone, via sms, internet or at office 
consultation (according to the authorization given to the e-CAP) by offering participation in the study and a visit 
will be scheduled to explain the study and to obtain the signed informed consent and the collection of data. 
The random distribution to the groups will be carried out centrally, through a computer program that generates the 
random numbers managed by a remote investigator to recruiters. The allocation of each patient will be hidden in an 
envelope that will be opened when the professional has confirmed that he complies with the selection criteria and 
the patient has signed the informed consent. 
Variables 
-Quality related to Health (QVRS) will be measured with specific and standardized self-administered 
questionnaires, validated by our environment: 

• St. George's Respiratory Questionnaire (SGRQ) 22. It is divided into three subscales: symptoms (eight items), 
activity (16 items), and impacts (26 items). For each subscale and for the general questionnaire, the scores range 
from 0 (without deterioration) to 100 (maximum deterioration). 
• COPD Assessment Test (CAT) 23. It consists of 8 questions with 5 possible answers valued from 0 to 5 (values 
close to 0: better health status) 
-Pulmonary function: it will be measured with forced spirometry with a bronchodilatation test. According to a FEV1 
/ FVC ratio <70% and the FEV1 post bronchodilatation, patients will be classified in COPD: MILD FEV1> 80%; 
MODERATE: 50% - 80%; SEVERE: 30% -50%; VERY SEVERE: <30% 24. 
-Dyspnea: Quantified by the modified scale of the Medical Research Council (mMRC) 25. It is part of the BODEx 
index (26). 
-Pronostic: BODEx index (26). This index that can be scored from 1 to 3, depending on the variables: body mass 
index, FEV1, dyspnea (mMRC25 scale) and severe exacerbations of COPD. 
-Anxiety and depression: they will be measured with the Goldberg's anxiety-depression scale (27). 
-Hospital admissions in the last year (computerized medical history review). 
Independent and confusing variables: 
- Socio-demographic variables: age (date of birth), gender and level of studies. 
-Date of diagnosis of COPD. 
-Phenotype: non exacerbator; asthma- COPD; exacerbator with emphysema; exacerbator with chronic bronchitis (1). 
Pharmacological treatment: 
-Type of treatment: LABA, LAMA, LAMA + LABA, CI, SABA, SAMA, roflumilast. 
-Pharmacological compliance: Assessed by the Morisky-Green test (28) that provides information about the causes 
of non-compliance. It consists of 4 questions with dichotomous response that must be introduced to the normal 
conversation with the patient. 
Inhalation technique: practical test evaluating step by step the technique according to SEPAR and SEMFYC (29) 
Comorbidities: hypertension, diabetes mellitus II, dyslipidaemia, depression and anxiety, joint disorders, 
cardiovascular disease, cardiovascular risk. 
Tobacco: Not Smoker / Smoker / former smokers. Yes smoker or ex-smoker: no packages / year. If you smoke 
number of cigarettes / day. Nicotine dependence (Fargeström) (30), Motivation for change (Richmond) (31) and 
Phase of change (Prochaska and DiClemente) (32). 
Alcohol: BU/week 
Working exposure 
Environmental exposure ambiental (contamination, tobacco...) 
-Other variables: 
-Degree of participation in the intervention: 1 session/ 2 sessions/ 3 sessions/ ≥ 4 sessions 
All the variables studied will be collected at baseline, prior to the intervention, and at 6, 12 and 24 months later, both 
in the intervention and in the control groups. 
The control group will follow the usual treatment and follow-up and a visit will be scheduled to obtain the same 
variables as the intervention group, on a first visit, and at 6 ,12 and 24months. 
Collection of data and sources of information: 

Data analysis: Analysis will be carried out by intention to treat basis. All patients who signed their informed consent 
and who have completed the initial evaluation will be included in the analysis. The descriptive statistics of 
dependent, confusing and general variables will be calculated, both for the intervention group and for the control 
group and the homogeneity of the two groups for these variables will be checked at the beginning of the study. In all 
cases, a bilateral alpha error of 0.05 will be considered and the confidence intervals will be calculated at 95%. A 
variable will be calculated for each 

measurement time (baseline, 6 months post-intervention and 12 and 24 months), which is the difference between the 
result of SGRQ and the other dependent variables of interest in each cut and the initial value, for each individual. 
Differences between groups and the confidence intervals of the difference to 95% will be calculated. An analysis of 
the variance of repeated measures (ANOVA) will be performed to evaluate the differences in time of dependent 
variables attributable to the effect of the intervention. It will adjust for the possible confusers, comorbidity, other 
interventions carried out, among others. 
Difficulties and limitations of the study: This is a clinical trial in which health professionals who usually see the 
subject of study can know the group to which the patient belongs. They will "try to preserve masking in some 
important stages of the study:random allocation, evaluation of the main measures, statistical analysis of the data. On 
the other hand, the duration of the study can lead to long term loss to follow-up . To ensure the patient's adherence 
telephone location will be performed (at least three attempts per appointment, if the patient has not indicated that he 
does not want to participate) when missing the intervention sessions and a quarterly reminder telephone contact. 
Ethical considerations and Confidentiality of the data 
This study will follow strictly the current regulations and national regulations related to the ethics committees and 
data protection rules. 
All recruited patients will be informed verbally and in writing of the objectives, methodology, tests and 
interventions they will receive if they participate in the study, and asked to sign informed consent. This document 
will be written in a language understood by the patient. The information will be treated anonymously. No user 
identification data will be computerized, and the whole study will be developed in accordance with the rules of good 
research practices. The study will be submitted to the CEIC of the IDIAP Jordi Gol. 
The processing, communication and assignment of personal data will be in accordance with the provisions of 
Organic Law 15/1999, of December 13, on the protection of personal data. According to what is established by law, 
the participant may exercise their right of access, modification, opposition and cancellation of data. 
Additional procedures derived from the study 
Group intervention: 4 to 6 visits will be scheduled withthe reference nurse, 20 "in duration and separated 15 days. 
Contents: Knowledge of the disease. Healthy lifestyle habits. Correct technique for the use of inhalers. Symptom 
control skills. Strategies for confronting the disease. 
Specific contents: Behavioral change techniques, knowledge about COPD, adherence to the therapeutic plan 
(pharmacological and non-pharmacological), abandonment of the tobacco habit, alcoholic beverages, avoidance of 
environmental and working exposures, recommended vaccinations, inhalation techniques, knowledge about drugs 
used, basic respiratory exercises, energy saving techniques, relaxation techniques, recognition and performance of 
exacerbations, physical exercise enhancement, correct nutrition, sexuality. 
The visits will be customized according to the clinical profile of the patient, the phenotype, the specific needs, their 
preferences and the stage of the change process in which he is found to be. All the sessions will be monitored by 
means of a specific track record where all activities / interventions will be collected, and the data collected (stage of 
the process of change, life habits: tobacco, diet, exercise, respiratory physiotherapy, inhalers ...). It will advise and 
facilitate attendance at the sessions of possible caregivers. 
The behavioral components common to all the sessions will be: the setting of objectives, the motivational interview, 
providing feedback and behavioral cognitive therapy. 
All learning will be based on educational material that will be provided to the patient: audiovisual, written 
educational material, links to web pages with useful and proven information (for example papsf ("Primary Health 
Care"), "the virtual nurse" or "caregiver" ) and, above all, the tutored practice of skills. 

4. APLICABILITY AND PRACTICAL UTILITY OF THE RESULTS OF THE STUDY 
Clinical Impact: The empowerment of the patient with COPD by facilitating his autonomy and self- responsibility 
will result in improved self-control of the disease and improvement in clinical outcomes. The application of 
knowledge from this research: structuring and standardizing the methods and contents of the nurse intervention in 
the COPD patient and their follow-up will also result in positive clinical outcomes. 
Practical utility of the results: Adapting to our population interventions that have been shown to improve the quality 
of life and the clinical parameters of patients with COPD. 
Scientific and socioeconomic relevance: This study will provide scientific evidence on the type of self- care 
intervention in patients with COPD in Primary Care that proves to be effective and will allow to formulate clear 
recommendations on ow to carry out this intervention by the nurse. On the other hand, the expected improvement in 
the quality of life and in the clinical parameters of the patients with COPD will contribute to reduce the expenses 
attributable to this disease, both in health and social resources (maintenance of functional life that will minimize the 
loss of working days , for example) 
Bibliometric impact: We believe that this study could generate a minimum of 3 communications in scientific 
meetings and 2 publications. 
Plan for the dissemination of results: The results of the study that provide relevant information, will be presented at 
conferences and will be published in national and international journals of nursing and medicine with great 
bibliometric impact. 
Innovation and transfer plan: The design of nursing training in order to carry out the intervention in our study, in an 
online format, can be spread to all the nursing staff in our surroundings in a fast way, to apply the methods and 
contents that have been proven effective in the usual care practise. The majority of the tests used in the data 
collection of the project, which are useful at the time of the intervention as they complement the patient's 
assessment, allows us to offer a more personalized attention and are perfectly implementable in the clinical practise 
(e-CAP). The use of new technologies is contemplated as they are part of our day to day practise and most patients 
use them, as a reinforcement of personal attention to the query. 
5.References 
1.Grupo de Trabajo de GesEPOC. Guía de Práctica Clínica para el Diagnóstico y Tratamiento de Pacientes con 
Enfermedad Pulmonar Obstructiva Crónica (EPOC). Guía Española de la EPOC (GesEPOC).Arch 
Bronconeumol.2012;48(supl 1):2-58. 
2.Chatila WM, Thomashow BM,Minai OA, Criner GJ,Make BJ. Comorbidities in chronic pulmonary obstructive 
disease.Proc Am Torac Soc [Internet].2008May 1[cited 2014 Nov 23];5(4)549-55. Available from: 
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2645334&tool=pmcentrez&rendert ype=abstract 
3.Cavaillès A, Brinchault-Rabin G, Dixmier A,Goupil F,Gut-Gobert C, Marchand-Adam S, et al. Comorbidities of 
COPD. Eur Respir Rev[Internet].2013 Dec[cited 2014 Dec 17];22(130):454-75. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/24293462 
4.Crisafulli E,Costi S, Luppi F,Cirelli G,Cilione C,Coletti O, et al.Role of comorbidities in a cohort of patients with 
COPD undergoing pulmonary rehabilitation. Thorax[Internet].2008 Jun 1[cited 2014 Dec 17];63(6):487-92. 
Available from: 
http://thorax.bmj.com/content/63/6/487.abstract?ijkey=b5c0371496b47f1663997109a75049ef 
3d8acb35&keytype2=tfipsecsha 
5.Barnes P CB, Systemic manifestations and comorbidities in COPD. Eur Resp J.2009;33:1165-85. 
6.Soriano JB SJC 12. How the COPD patient should be assesed for co-morbidities. En Rennard I, al , eds Clin 
Manag chronic Obstr lung Dis 2nd ed Bost Inf Healthc;2007. 

7.Lenferink A,Frith P, van der Valk P, Buckman J, Sladek R, Cafarella P, et al. A self- management approach using 
self-initiated action plans for symptoms with ongoing nurse suport in patients with Chronic Obstructive Pulmonary 
Disease (COPD) and comorbidities: the COPD III study protocol. Contemo Clin Trials[Internet].2013 sep[cited 
2014 Dec 17];36(1):81-9. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/23770110 
8.Pauwels RA, Buist AS, Calverley PM, Jenkins CR, Hurd SS. Global strategy for the diagnosis, management and 
prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung 
Disease (GOLD) Workshop summary.Am J Respir Crit Care Med[Internet]. 2001;163:1256-76. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/11316667 
9.Parker DR, Eaton CB, Ahern DK, Roberts MB, Rafferty C, Goldmas RE, et al. The study design and rationale of 
the randomized controlled trial:translating COPD guidelines into primary care practice. BMC Fam PRACT 
[Internet]. 2013 Jan[cited 2014;14:56. Avalaible from: 
http://www.pubmedcentrel.nih.gov/articlerender.fcgi?artid=3651367&tool=pmcentrez&rendert ype=abstract 
10.Lozano R,Naghavi M, Foreman K, Lim S,et al. Global and regional mortality from 235 causes of death for 20 
age groups in 1990 and 2010: A systematic analysis for the Global Borden of Disease Study 
2010.Lancet.2012.;380(9859):2095-128. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/2324560404 
11.Soriano JB, Ancochea J, Miravitlles M, García-Río F, Duran-Tauleria E, Muñoz L, Jiménez-Ruiz CA, Masa JF, 
Viejo JL, Villasante C, Fernández-Fau L, Sánchez G, Sobradillo-Peña V. Recent trends in COPD prevalence in 
Spain: a repeated cross- sectional survey 1997-2007. Eur Respir J. 2010;36:758-65. 
12.Soriano JB, Miravitlles M. Datos epidemiológicos de EPOC en España. Arch Bronconeumol.2007;43(Supl1):2-9. 
13.IDESCAT. http://www.idescat.cat/pub/?id=aec&n=285 
14.Ministerio de Sanidad, Política Social e Igualdad. Plan de Calidad para el Sistema Nacional de Salud. Estrategia 
en EPOC del Sistema Nacional de Salud.[Internet]. Madrid. El Ministerio:2009. 
http://www.msssi.gob.es/organizacion/sns/planCalidadSNS/docs/EstrategiaEPOCSNS.pdf 
15.Guia MPOCfilmar Guia ICS_Gencat.cat 
https://www.gencat.cat/ics/.../guies/.../guia_mpoc.pdf 
16.TERMCAT.Terminología de la cronicitat. 
http://www.termcat.cat 
17. J. Bourbeau,M. Julien,F. Maltais,M. Rouleau,A. Beaupré,R. Bégin. Reduction of hospital utilization in patients 
with chronic obstructive pulmonary disease: a disease-specific self- management intervention. Arch Intern Med 
2003; 163: 585-591 
18. E. Monninkhof,P. Van der Valk,J. Van der Palen,C. Van Herwaarden, G. Zielhuis. Effects of a comprehensive 
self-management programme in patients with chronic obstructive pulmonary disease. Eur Respir J 2003; 22: 815-
820 
19.Disease-specific Health education for COPD: a systematic review of changes in Health 
outcomes.2007.(SYSREV-12007003344) 
20.Revisión Sistemática Cochrane 2014. Self-management following an acute exacerbation of COPD: a systematic 
review (ID:SYSREV-12014063527). 
21.Propostes per a l‟ elaboració del Pla de Salut de Catalunya 2016-2020.Pla de Salut. Quaderns. Número 1. Febrer 
2015. Generalitat de Catalunya. Departament de Salut 

22. Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-completed measure of health status for chronic 
airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 ;145:1321-7 

23. Jones P.W, Harding G, Berry, Wiklund I, Chen W-H, Kline Leidy . Development and first validation of the 
COPD assessment test. Eur Respir J, 2009;34: 648 654. 
24. Global Strategy for the Diagnosis, Management and Prevention of COPD 2013, Global Initiative for Chronic 
Obstructive Lung Disease (GOLD), www.goldcopd.org 
25. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with 
chronic obstructive pulmonary disease. J.C. Bestall,E.A. Paul,R. Garrod,R. Garnham,P.W. Jones,J. Wedzicha JA. 
Thorax 1999;54:581- 85 
26. Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The 
body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary 
disease. N Engl J Med. 2004;350:1005-12. 
27.Goldberg DP, Hillier VF. A scaled version of the General Health Questionnaire. Psychological Medicine 
1979;9:139-145 
28. Val Jiménez A, Amorós Ballestero G, Martínez Visa P, Fernández Ferré ML, León Sanromà M. Estudio 
descriptivo del cumplimiento del tratamiento farmacológico antihipertensivo y validación del test de Morisky y 
Green. Aten Primaria. 1992;10:767-70. 
29. Consensus for Inhaled Therapies. Área de asma de SEPAR, Área de enfermería de SEPAR, Departamento de 
asma ALAT. Arch Bronconeumol. 2013;49(Supl 1):2-14 
30. Fargeström T.F, Heatherton,L.T, Kozlowsky,R.C, Frecker,T, Baker,W, Whisler,K.O. The Fagerström test for 
nicotine dependence: A revision of the Fagerström tolerance questionnaire.Br J Addict 1991; 86 : 1119-1127 
31. Richmond RL, Kehoe LA, Webster IW. Multivariate models for predicting abstention following intervention to 
stop smoking by general practitioners. Addiction. 1993; 88: 1127- 1135 
32. Prochaska JO, Velicer WF, Prochaska JM, Johnson JL. Size, consistency, and stability of stage effects for 
smoking cessation. Addict Behav. 2004;29:207-13