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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03762330
• Other study ID #: P17/055
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2019
• Est. completion date: January 2021

Study information

• Verified date: July 2020
• Source: Jordi Gol i Gurina Foundation
• Contact: Maite Lopez Luque
• Phone: 93 326 89 01
• Email: tlopezl[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• COPD structured self-management plan.
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

Locations

Country	Name	City	State
Spain	EAP Montcada i Reixac	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Institut Catala de Salut

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of COPD exacerbations	Number of COPD exacerbations requiring a visit to primary care physician	at 6 ,12 and 24 months from baseline
Secondary	Number of hospital admissions due to COPD exacerbation	Number of hospital admissions due to COPD exacerbation	at 6 ,12 and 24 months from baseline
Secondary	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
Secondary	Changes in forced vital capacity (FVC)	Value of FVC measured with forced spirometry	Change from baseline at 6 ,12 and 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Use of Roflumilast	Use of Roflumilast (yes or no)	At baseline and at 6 ,12 and 24 months