SATisfaction and Adherence to COPD Treatment

NCT ID: NCT02689492

Last Updated: 2019-08-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

401 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-11

Study Completion Date

2017-09-15

Brief Summary

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The present study will explore the patients satisfaction to COPD medical treatment (i.e. pharmacological and not pharmacological treatment) in a clinical real-world setting and how the satisfaction for medical treatment is related to clinical parameters, quality of life, illness perception and treatment adherence evolution.

Moreover health care resource consumption will be observed during the observation period.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Patients aged equal or more than 40 years
2. Patients must have a documented diagnosis of chronic obstructive pulmonary disease (COPD)
3. Patients with no exacerbations in the last 3 months
4. Patients requiring regular treatment according to GOLD guidelines, i.e.: undergoing stable pharmacological treatment for COPD since at least 3 months
5. Written informed consent to both participation in the study and privacy form
6. Patients capable of discernment and able to read or write in Italian language.

Exclusion Criteria

1. Patients who are currently participating in a clinical trial on experimental drugs.
2. Patients naïve to pharmacological treatment for COPD
3. Diagnosis of Asthma COPD Overlap Syndrome (ACOS)
Minimum Eligible Age

40 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

Alessandria, , Italy

Site Status

I.N.R.C.A. - I.R.C.C.S Ospedale Geriatrico Ugo Sestili

Ancona, , Italy

Site Status

Ospedale Reg Umberto Parini

Aosta, , Italy

Site Status

A. O. Giuseppe Moscati

Avellino, , Italy

Site Status

Ospedale Civile di Battipaglia

Battipaglia Salerno, , Italy

Site Status

IRCCS - Istituto Scientifico di Cassano delle Murge

Cassano Murge Bari, , Italy

Site Status

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

CONA (FE), , Italy

Site Status

Policlinico San Martino

Genova, , Italy

Site Status

Az. Unità Loc. Socio-Sanitaria 21 -

Legnago, , Italy

Site Status

Spedali Riuniti di Livorno

Livorno, , Italy

Site Status

Fondazione Salvatore Maugeri

Milan, , Italy

Site Status

Asst Santi Paolo E Carlo

Milan, , Italy

Site Status

Osp. dei Colli Monaldi-Cotugno

Napoli, , Italy

Site Status

Azienda Sanitaria Ospedale S. Luigi Gonzaga

Orbassano, , Italy

Site Status

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

Palermo, , Italy

Site Status

Fondazione IRCCS Policlinico S. Matteo

Pavia, , Italy

Site Status

Azienda Unità Sanitaria Locale di Reggio Emilia

Reggio Emilia, , Italy

Site Status

Pol. Universitario Tor Vergata

Roma, , Italy

Site Status

Ospedale Civile Mazzini

Teramo, , Italy

Site Status

ASL 4 di Terni

Terni, , Italy

Site Status

Countries

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Italy

References

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Contoli M, Rogliani P, Di Marco F, Braido F, Corsico AG, Amici CA, Piro R, Sarzani R, Lessi P, Scognamillo C, Scichilone N, Santus P; SAT Study Group. Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study. Ther Adv Respir Dis. 2019 Jan-Dec;13:1753466619888128. doi: 10.1177/1753466619888128.

Reference Type DERIVED
PMID: 31760881 (View on PubMed)

Corsico AG, Braido F, Contoli M, Di Marco F, Rogliani P, Scognamillo C, Olivi I, Santus P, Scichilone N, Lazzaro C. Healthcare costs of the SATisfaction and adherence to COPD treatment (SAT) study follow-up. Respir Med. 2019 Jul;153:68-75. doi: 10.1016/j.rmed.2019.05.017. Epub 2019 May 29.

Reference Type DERIVED
PMID: 31174106 (View on PubMed)

Baiardini I, Rogliani P, Santus P, Corsico AG, Contoli M, Scichilone N, Di Marco F, Lessi P, Scognamillo C, Molinengo G, Ferri F, Patella V, Fiorentino G, Carone M, Braido F. Disease awareness in patients with COPD: measurement and extent. Int J Chron Obstruct Pulmon Dis. 2018 Dec 17;14:1-11. doi: 10.2147/COPD.S179784. eCollection 2019.

Reference Type DERIVED
PMID: 30587957 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1237.51

Identifier Type: -

Identifier Source: org_study_id

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