Evaluation of a Combined Strategy Addressed to Practitioners and Chronic Obstructive Pulmonary Disease (COPD) Patients to Improve Clinical Control and Quality of Life

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Evaluation of a Combined Strategy Addressed to Practitioners and COPD Patients: Information Feed-back and Health Education, to Improve Clinical Control and Quality of Life

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00922545
• Other study ID #: 550.62
• Status: Active, not recruiting
• Phase: N/A
• First received: June 16, 2009
• Last updated: October 8, 2009
• Start date: April 2004
• Est. completion date: December 2010

Study information

• Verified date: October 2009
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

Main objective:

Evaluate the effectiveness of a combined strategy addressed to health care workers and patients, in relation to improving clinical control and patient's quality of life.It includes a feed-back about the health status of the patients, an education plan addressed to practitioners based in a CPG and in health education

Description:

Method/design:

Design: Multicenter intervention study(before-after), quasi-experimental, prospective, with a control group and 12 month's follow-up

Setting: 21 primary Health Care Centres in Barcelona (Spain)

Sample: 801 patients (≥ 40 years old) with a register of COPD diagnostic,with one visit motivated by COPD during 2003 and that accept to participate at the study, after having read and signed the informed consent.

Intervention: The program includes giving clinical results to the health care workers(doctor and nurse), from the medical records and interview. A training course (20h)that deals with aspects related to GPC, motivational interview and health education (tobacco, inhalers, alimentation, exercise and physiotherapy).

Main variables: socio-demographic characteristics, quality of life, dyspnea, pharmacological treatment, exacerbations and hospital admissions, evaluation of inhalers technique, tobacco consumption, lifestyles and health resources used.

Measures: quality of life was evaluated with the Saint george's Respiratory Questionnaire (SGRQ) and dyspnea with the modified scale of the Medical Research Council (MRC). The variables are obtained at the beginning of the intervention and at the end (12 months after). Information about possible changes in lifestyle is gathered during the follow-up visits.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 801
• Est. completion date: December 2010
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients of both genders aged =40 years of age, recorded as having COPD, receiving attention in the PCC or at home, who have had at least one clinical visit for COPD management, and who provide written informed consent to participation in the study.

Exclusion Criteria:

• Patients who have any psychiatric disturbances, severe visual or auditory impairment that would impede compliance with the study protocol.

• Patients with asthma, tuberculosis or other chronic respiratory pathologies, or any end-stage disease, or not having access to a telephone.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Other:
• Implementation of Clinical Practice Guidelines (GPC) and Health Education Program
Intervention: The program includes giving clinical results to the health care workers(doctor and nurse), from the medical records and interview. A training course (20h)that deals with aspects related to GPC, motivational interview and health education (tobacco, inhalers, alimentation, exercise and physiotherapy).

Locations

Country	Name	City	State
Spain	Institut Català de la Salut	Cornellà de Llobregat	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Catalan Society of Family Medicine, Unitat de Suport a la Recerca de la Direcció d'Atenció Primària de Costa de Ponent

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (Saint George's Respiratory Questionnaire (SGRQ)		Beginning of the intervention and at the end (12 months after)	No
Secondary	Dyspnea, exacerbations and hospital admissions		Beginning of the intervention and at the end (12 months after)	No