Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in COPD Patients

Study Overview
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Brief Summary
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This study evaluates the effect of of a structured self-management intervention plan in patients with chronic obstructive pulmonary disease in primary care setting.Half of the participants will receive the self-management plan while the other half will receive usual care.

Detailed Description
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Chronic Obstructive Pulmonary Disease (COPD) is a great magnitude public health problem with an associated increased mortality and a high cost (consumption of health care resources and loss of health related quality of life (HRQoL)). The comprehensive approach to this complex disease, focusing self-care promotion, improves HRQoL and the patients clinical status, as shown by several studies, although further investigation is needed to confirm these results in the field of Primary Care (PC) and to formulate clear recommendations on the more effective type of intervention. Hypothesis: In (moderate-severe) COPD patients, a structured self-management intervention plan in the setting of primary care, is more effective than usual treatment on the main outcomes associated with the disease: HRQoL, lung function, exacerbations and hospital admissions, at 6, 12 and 24 months of follow-up. Objectives: To evaluate the impact of a comprehensive intervention plan to promote self-care and improve HRQoL in people with COPD in PC. Methods: Multicenter randomized controlled trial, conducted at PC centers in Barcelona. Determinations: Specific standardized and validated questionnaires, as the St George's Respiratory for the HRQoL. Statistical analysis: Intention to treat analysis. Descriptive statistics of the variables of the intervention and the control group to assess their homogeneity at the beginning of the study. An analysis of variance (ANOVA) will be used to assess differences among intervention groups. Expected results: A significant improvement in HRQoL attributable to the intervention performed in patients with COPD Applicability and Relevance: To implement the intervention plan in clinical practice and to standardize its content.

Official Title
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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.

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: COPD structured self-management plan.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with at least one visit at the primary care physician during the past year Patients with a diagnosis of moderate (FEV1 50% - 80%) or severe (FEV1 30% - 50%) COPD Patients treated with inhaled bronchodilators and accepting to participate in the study. Exclusion Criteria: Patients unable to come to the primary care centre Patients with cognitive impairment and/or a severe mental condition. Patients with a diagnosis of asthma, tuberculosis or other chronic respiratory disease. Patients needing chronic oxygen therapy. Patients with any terminal disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COPD structured self-management plan<br>Participants will receive usual care for COPD and in addition, a structured self-management education plan. | Behavioral: COPD structured self-management plan.<br>* Education plan , including knowledge of the disease, healthy life habits, correct use of inhalers, skills to control symptoms and strategies to face the disease and exacerbations<br>|
| No Intervention: Usual care<br>COPD participants receiving only usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life St. George´s Respiratory Questionnaire (SGRQ) | St. George´s Respiratory Questionnaire (SGRQ).Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Number of items: 50 items Number of domains & categories : 2 parts (3 components). Part 1 : Symptoms component (frequency & severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall. Scaling of items Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale). Scores range from 0 to 100, with higher scores indicating more limitations. | Change from baseline at 6 ,12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of symptoms related to COPD | COPD Assessment Test (CAT) : It consists of 8 questions with 5 possible answers valued from 0 to 5 (values close to 0: better health status) | Change from baseline at 6 ,12 and 24 months | 
| Dyspnea score severity | Dyspnea severity assessed by the modified scale of the Medical Research Council (mMRC). Range 0-4 (none to maximum) | Change from baseline at 6 ,12 and 24 months | 
| Changes in the Body mass index, Obstruction, Dyspnea, Exacerbations Index (BODEx index ) | Index including BMI (Body mass index), Obstruction, Dyspnea, Exacerbations. with possible answers from 0-3, each item. Range: 0-9. Mild: 0-2 Moderate: 3-4 Severe ≥5 | Change from baseline at 6 ,12 and 24 months | 
| Number of COPD exacerbations | Number of COPD exacerbations requiring a visit to primary care physician | at 6 ,12 and 24 months from baseline | 
| Number of hospital admissions due to COPD exacerbation | Number of hospital admissions due to COPD exacerbation | at 6 ,12 and 24 months from baseline | 
| Changes in Anxiety and depression scales | Goldberg's anxiety-depression scale (GADS): is an 18-item self-report symptom inventory that was developed by Goldberg and colleagues from 36 items in the Psychiatric Assessment Schedule. The GADS score is based on responses of 'yes' or 'no' to nine depression and nine anxiety items, asking how respondents have been feeling in the past month. Goldberg et al. (1988) considered patients with anxiety scores of 5 or more or with depression scores of 2 or more as having a 50% chance of a clinically important disturbance | Change from baseline at 6 ,12 and 24 months | 
| Changes in forced vital capacity (FVC) | Value of FVC measured with forced spirometry | Change from baseline at 6 ,12 and 24 months | 
| Changes in forced expiratory volume at the first second (FEV1) | Value of FEV1 measured with forced spirometry | Change from baseline at 6 ,12 and 24 months | 
| Results of the Test of Adherence to Inhalers (TAI test) | TAI test. Includes 10 questions self-completed by patient. Range of each questions; 1worse compliance and 5 best compliance. The total score of the 10 items gives a total from 1-50. | Change from baseline at 6 ,12 and 24 months | 
| Use of long-acting beta-adrenergic bronchodilator in monotherapy | Use of long-acting beta-adrenergic bronchodilator in monotherapy (yes or no) | At baseline and at 6 ,12 and 24 months | 
| Use of long-acting anticholinergic bronchodilator in monotherapy | Use of long-acting anticholinergic bronchodilator in monotherapy (yes or no) | At baseline and at 6 ,12 and 24 months | 
| Use of a double therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator | Use of a double therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator (yes or no) | At baseline and at 6 ,12 and 24 months | 
| Use of a double therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator | Use of a double therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator (yes or no) | At baseline and at 6 ,12 and 24 months | 
| Use of a triple therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator plus inhaled steroids | Use of a triple therapy of long-acting beta-adrenergic bronchodilator plus long-acting anticholinergic bronchodilator plus inhaled steroids (yes or no) | At baseline and at 6 ,12 and 24 months | 
| Use of a triple therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator plus inhaled steroids | Use of a triple therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator plus inhaled steroids (yes or no) | At baseline and at 6 ,12 and 24 months | 
| Use of Roflumilast | Use of Roflumilast (yes or no) | At baseline and at 6 ,12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, self-management,, structured plan, COPD