Evaluation of a Combined Strategy Addressed to Practitioners and Chronic Obstructive Pulmonary Disease (COPD) Patients to Improve Clinical Control and Quality of Life
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Implementation of Clinical Practice Guidelines (GPC) and Health Education Program
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease, Quality of life, Primary health care
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.
Sites / Locations
- Institut Català de la Salut
Outcomes
Primary Outcome Measures
Quality of life (Saint George's Respiratory Questionnaire (SGRQ)
Secondary Outcome Measures
Dyspnea, exacerbations and hospital admissions
Full Information
NCT ID
NCT00922545
First Posted
June 16, 2009
Last Updated
October 8, 2009
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Unitat de Suport a la Recerca de la Direcció d'Atenció Primària de Costa de Ponent, Catalan Society of Family Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00922545
Brief Title
Evaluation of a Combined Strategy Addressed to Practitioners and Chronic Obstructive Pulmonary Disease (COPD) Patients to Improve Clinical Control and Quality of Life
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2007 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Unitat de Suport a la Recerca de la Direcció d'Atenció Primària de Costa de Ponent, Catalan Society of Family Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease, Quality of life, Primary health care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
801 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Implementation of Clinical Practice Guidelines (GPC) and Health Education Program
Intervention Description
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).
Primary Outcome Measure Information:
Title
Quality of life (Saint George's Respiratory Questionnaire (SGRQ)
Time Frame
Beginning of the intervention and at the end (12 months after)
Secondary Outcome Measure Information:
Title
Dyspnea, exacerbations and hospital admissions
Time Frame
Beginning of the intervention and at the end (12 months after)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Institut Català de la Salut
City
Cornellà de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
20128887
Citation
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.
Results Reference
derived
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Evaluation of a Combined Strategy Addressed to Practitioners and Chronic Obstructive Pulmonary Disease (COPD) Patients to Improve Clinical Control and Quality of Life
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