Chronic Obstructive Pulmonary DiseaseNCT00922545
Evaluation of a Combined Strategy Addressed to Practitioners and Chronic Obstructive Pulmonary Disease (COPD) Patients to Improve Clinical Control and Quality of Life
A study testing Implementation of Clinical Practice Guidelines (GPC) and Health Education Program in people with Chronic Obstructive Pulmonary Disease, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Implementation of Clinical Practice Guidelines (GPC) and Health Education Program
- How many people
- 801 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2004to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Implementation of Clinical Practice Guidelines (GPC) and Health Education Program
- Keywords
- Chronic obstructive pulmonary disease, Quality of life, Primary health care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of Clinical Practice Guidelines (GPC) and Health Education ProgramOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (Saint George's Respiratory Questionnaire (SGRQ)
Measured: Beginning of the intervention and at the end (12 months after)
Secondary outcomes (1)
Dyspnea, exacerbations and hospital admissions
Measured: Beginning of the intervention and at the end (12 months after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startApr 2004
- Primary completionDec 2007 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Unitat de Suport a la Recerca de la Direcció d'Atenció Primària de Costa de Ponent, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922545
- Sponsor's protocol ID
- 550.62
- Status last verified
- Oct 2009
- First submitted
- 16 Jun 2009
- Last updated
- 9 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20128887
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00922545
- Acronym / sponsor ID
- 550.62
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Quality of life, Primary health care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 801 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Unitat de Suport a la Recerca de la Direcció d'Atenció Primària de Costa de Ponent, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Study start
- Apr 2004
- Primary completion
- Dec 2007 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of Clinical Practice Guidelines (GPC) and Health Education ProgramIntervention: 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). | Other | – |
Primary outcome
Quality of life (Saint George's Respiratory Questionnaire (SGRQ)
Time frame: Beginning of the intervention and at the end (12 months after)
1 secondary outcome
Dyspnea, exacerbations and hospital admissions
Time frame: Beginning of the intervention and at the end (12 months after)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2009.
- Derived from this study: PubMed 20128887Valero 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.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of Clinical Practice Guidelines (GPC) and Health Education Program in people with Chronic Obstructive Pulmonary Disease, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (Saint George's Respiratory Questionnaire (SGRQ) (time frame: Beginning of the intervention and at the end (12 months after)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00922545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2009.