Evaluation of a Combined Strategy Addressed to Practitioners and Chronic Obstructive Pulmonary Disease (COPD) Patients to Improve Clinical Control and Quality of Life
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|ClinicalTrials.gov Identifier: NCT00922545|
Recruitment Status : Unknown
Verified October 2009 by Jordi Gol i Gurina Foundation.
Recruitment status was: Active, not recruiting
First Posted : June 17, 2009
Last Update Posted : October 9, 2009
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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: Implementation of Clinical Practice Guidelines (GPC) and Health Education Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||801 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2004|
|Estimated Primary Completion Date :||December 2007|
|Estimated Study Completion Date :||December 2010|
Other: Implementation of Clinical Practice Guidelines (GPC) and Health Education Program
- Quality of life (Saint George's Respiratory Questionnaire (SGRQ) [ Time Frame: Beginning of the intervention and at the end (12 months after) ]
- Dyspnea, exacerbations and hospital admissions [ Time Frame: Beginning of the intervention and at the end (12 months after) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922545
|Institut Català de la Salut|
|Cornellà de Llobregat, Barcelona, Spain, 08950|