NCT00922545

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
801

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 9, 2009

Status Verified

October 1, 2009

Enrollment Period

3.7 years

First QC Date

June 16, 2009

Last Update Submit

October 8, 2009

Conditions

Keywords

Chronic obstructive pulmonary diseaseQuality of lifePrimary health care

Outcome Measures

Primary Outcomes (1)

  • Quality of life (Saint George's Respiratory Questionnaire (SGRQ)

    Beginning of the intervention and at the end (12 months after)

Secondary Outcomes (1)

  • Dyspnea, exacerbations and hospital admissions

    Beginning of the intervention and at the end (12 months after)

Interventions

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).

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Català de la Salut

Cornellà de Llobregat, Barcelona, 08950, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycophorins

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SialoglycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesGlycopeptidesPeptidesAmino Acids, Peptides, and ProteinsProteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 17, 2009

Study Start

April 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2010

Last Updated

October 9, 2009

Record last verified: 2009-10

Locations