Evaluation of a Combined Strategy Addressed to Practitioners and Chronic Obstructive Pulmonary Disease (COPD) Patients to Improve Clinical Control and Quality of Life
Recruitment status was Active, not recruiting
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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 |
- 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 ]
- 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) |
-
Other: Implementation of Clinical Practice Guidelines (GPC) and Health Education Program
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 |
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| Spain | |
| Institut Català de la Salut | |
| Cornellà de Llobregat, Barcelona, Spain, 08950 | |
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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013