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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Jordi Gol i Gurina Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Unitat de Suport a la Recerca de la Direcció d'Atenció Primària de Costa de Ponent
Catalan Society of Family Medicine
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT00922545
First received: June 16, 2009
Last updated: October 8, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: Implementation of Clinical Practice Guidelines (GPC) and Health Education Program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Quality of life (Saint George's Respiratory Questionnaire (SGRQ) [ Time Frame: Beginning of the intervention and at the end (12 months after) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dyspnea, exacerbations and hospital admissions [ Time Frame: Beginning of the intervention and at the end (12 months after) ] [ Designated as safety issue: No ]

Enrollment: 801
Study Start Date: April 2004
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922545

Locations
Spain
Institut Català de la Salut
Cornellà de Llobregat, Barcelona, Spain, 08950
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Unitat de Suport a la Recerca de la Direcció d'Atenció Primària de Costa de Ponent
Catalan Society of Family Medicine
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carles Valero, Servei d'Atenció Primària Dreta.Institut Català de la Salut
ClinicalTrials.gov Identifier: NCT00922545     History of Changes
Other Study ID Numbers: 550.62
Study First Received: June 16, 2009
Last Updated: October 8, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Jordi Gol i Gurina Foundation:
Chronic obstructive pulmonary disease
Quality of life
Primary health care

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014