This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Treatment implementation of clinical practice guidelines (gpc) and health education program
Sponsor Jordi Gol i Gurina Foundation
Collaborator Unitat de Suport a la Recerca de la Direcció d'Atenció Primària de Costa de Ponent
Start date April 2004
End date December 2007
Trial size 801 participants
Trial identifier NCT00922545, 550.62


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Quality of life (Saint George's Respiratory Questionnaire (SGRQ)
time frame: Beginning of the intervention and at the end (12 months after)

Secondary Outcomes

Dyspnea, exacerbations and hospital admissions
time frame: Beginning of the intervention and at the end (12 months after)

Eligibility Criteria

Male or female participants at least 40 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by Jordi Gol i Gurina Foundation.