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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Implementation of Clinical Practice Guidelines (GPC) and Health Education Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (Saint George's Respiratory Questionnaire (SGRQ) |  | Beginning of the intervention and at the end (12 months after) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea, exacerbations and hospital admissions |  | Beginning of the intervention and at the end (12 months after) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease, Quality of life, Primary health care