SATisfaction and Adherence to COPD Treatment

NCT02689492 | Completed Results

• 1 other identifier: 1237.51
• Study Type: observational
• Target: 401
• Locations: 1 country
• Sites: 20

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period

  Patient's self-reported satisfaction or dissatisfaction with pharmacological treatments was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4, a validated instrument. The TSQM has total 9 items (TSMQ-9) with responses to nearly all items rated on a 5-point or 7-point rating scale that provide scores on 3 scales: effectiveness (items #1 #2 #3), convenience (items #4 #5 #6) and global satisfaction (items #7 #8 #9). The TSQM-9 domain scores were calculated as recommended by the instrument authors. (i) Effectiveness = \[(item1 + item2 + item3) - 3\]/18\*100, (ii) Convenience = \[(item4 + item5 + item6) - 3\]/18\*100 and (iii) Global satisfaction = \[(item7 + item8 + item9) - 3\]/14\*100. Each domain score can be calculated only if all the three items considered in the calculation of that score are not missing. The TSQM-9 domain scores range from 0 to 100, with higher scores representing higher satisfaction on that domain.

  At enrollment visit, 6-month follow-up visit and 12-month follow-up visit.

Secondary Outcomes (6)

• Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period.

  At enrollment visit, 6-month follow-up visit and 12-month follow-up visit

• The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.

  Up to 12 months

• The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.

  Up to 12 months

• The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.

  Up to 12 months

• The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period

  Up to 12 months

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD pts

You may qualify if:

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

You may not qualify if:

• Patients who are currently participating in a clinical trial on experimental drugs.
• Patients naïve to pharmacological treatment for COPD
• Diagnosis of Asthma COPD Overlap Syndrome (ACOS)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (20)

Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

Location

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

Ancona, 60127, Italy

Location

Ospedale Reg Umberto Parini

Aosta, 11100, Italy

Location

A. O. Giuseppe Moscati

Avellino, 83100, Italy

Location

Ospedale Civile di Battipaglia

Battipaglia Salerno, 84091, Italy

Location

IRCCS - Istituto Scientifico di Cassano delle Murge

Cassano Murge Bari, 70020, Italy

Location

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

CONA (FE), 44124, Italy

Location

Policlinico San Martino

Genova, 16132, Italy

Location

Az. Unità Loc. Socio-Sanitaria 21 -

Legnago, 37045, Italy

Location

Spedali Riuniti di Livorno

Livorno, 57100, Italy

Location

Fondazione Salvatore Maugeri

Milan, 20138, Italy

Location

Asst Santi Paolo E Carlo

Milan, 20142, Italy

Location

Osp. dei Colli Monaldi-Cotugno

Napoli, 80131, Italy

Location

Azienda Sanitaria Ospedale S. Luigi Gonzaga

Orbassano, 10043, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

Palermo, 90146, Italy

Location

Fondazione IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

Azienda Unità Sanitaria Locale di Reggio Emilia

Reggio Emilia, 42123, Italy

Location

Pol. Universitario Tor Vergata

Roma, 00133, Italy

Location

Ospedale Civile Mazzini

Teramo, 64100, Italy

Location

ASL 4 di Terni

Terni, 05100, Italy

Location

Related Publications (3)

• 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.

  PMID: 31760881 DERIVED

• 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.

  PMID: 31174106 DERIVED

• 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.

  PMID: 30587957 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Neither study was designed to prove the existence clinical factors of any causal relationship nor foreseen a selection method for balanced groups. Neither treatment satisfaction was assessed nor validated to identify patients' satisfaction.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: February 24, 2016
• Study Start: December 11, 2015
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-07

Locations

IT (20)