Clinical trial NCT02689492: SATisfaction and Adherence to COPD Treatment
Official title: SATisfaction and Adherence to COPD Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-02-24
Enrollment: 401
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD pts

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period
timeFrame: At enrollment visit, 6-month follow-up visit and 12-month follow-up visit.
Secondary outcomes:
measure: Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period.
timeFrame: At enrollment visit, 6-month follow-up visit and 12-month follow-up visit
measure: The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
timeFrame: Up to 12 months
measure: The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
timeFrame: Up to 12 months
measure: The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
timeFrame: Up to 12 months
measure: The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period
timeFrame: Up to 12 months
measure: Correlation Between Patients' Satisfaction and Resource Utilization
timeFrame: 12-month follow-up visit
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: I.N.R.C.A. - I.R.C.C.S Ospedale Geriatrico Ugo Sestili
city: Aosta
country: Italy
facility: Ospedale Reg Umberto Parini
city: Avellino
country: Italy
facility: A. O. Giuseppe Moscati
city: Battipaglia Salerno
country: Italy
facility: Ospedale Civile di Battipaglia
city: Cassano Murge Bari
country: Italy
facility: IRCCS - Istituto Scientifico di Cassano delle Murge
city: Cona (fe)
country: Italy
facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
city: Genova
country: Italy
facility: Policlinico San Martino
city: Legnago
country: Italy
facility: Az. Unità Loc. Socio-Sanitaria 21 -
city: Livorno
country: Italy
facility: Spedali Riuniti di Livorno
city: Milano
country: Italy
facility: Fondazione Salvatore Maugeri
city: Milano
country: Italy
facility: Asst Santi Paolo E Carlo
city: Napoli
country: Italy
facility: Osp. dei Colli Monaldi-Cotugno
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S. Matteo
city: Reggio Emilia
country: Italy
facility: Azienda Unità Sanitaria Locale di Reggio Emilia
city: Roma
country: Italy
facility: Pol. Universitario Tor Vergata
city: Teramo
country: Italy
facility: Ospedale Civile Mazzini
city: Terni
country: Italy
facility: ASL 4 di Terni
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.