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

NCT ID: NCT00922545

Last Updated: 2009-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

801 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2010-12-31

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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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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).

Intervention Type OTHER

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unitat de Suport a la Recerca de la Direcció d'Atenció Primària de Costa de Ponent

UNKNOWN

Sponsor Role collaborator

Catalan Society of Family Medicine

OTHER

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

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Servei d'Atenció Primària Dreta.Institut Català de la Salut

Locations

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Institut Català de la Salut

Cornellà de Llobregat, Barcelona, Spain

Site Status

Countries

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Spain

References

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Valero C, Monteagudo M, Llagostera M, Bayona X, Granollers S, Acedo M, Ferro JJ, Rodriguez-Latre L, Almeda J, Munoz L; COPD Group of SAP Baix LLobregat Centre. Evaluation of a combined strategy directed towards health-care professionals and patients with chronic obstructive pulmonary disease (COPD): information and health education feedback for improving clinical monitoring and quality-of-life. BMC Public Health. 2009 Dec 1;9:442. doi: 10.1186/1471-2458-9-442.

Reference Type DERIVED
PMID: 20128887 (View on PubMed)

Other Identifiers

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550.62

Identifier Type: -

Identifier Source: org_study_id

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