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Clinical Trials/NCT00922545
NCT00922545
Unknown
Not Applicable

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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina1 site in 1 country801 target enrollmentApril 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Enrollment
801
Locations
1
Primary Endpoint
Quality of life (Saint George's Respiratory Questionnaire (SGRQ)
Last Updated
16 years ago

Overview

Brief 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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 2004
End Date
December 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Eligibility Criteria

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.

Outcomes

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(Beginning of the intervention and at the end (12 months after))

Study Sites (1)

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