Pulmonary Disease, Chronic ObstructiveNCT02689492

SATisfaction and Adherence to COPD Treatment

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 20 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 40 to 99 years
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
How many people: 401 participants
Where: 20 sitesItaly
Study dates: 11 Dec 2015to 15 Sep 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: COPD pts

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

Italy20 sites

Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
I.N.R.C.A. - I.R.C.C.S Ospedale Geriatrico Ugo Sestili
Ancona, 60127
Ospedale Reg Umberto Parini
Aosta, 11100
A. O. Giuseppe Moscati
Avellino, 83100
Ospedale Civile di Battipaglia
Battipaglia Salerno, 84091
IRCCS - Istituto Scientifico di Cassano delle Murge
Cassano Murge Bari, 70020
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
CONA (FE), 44124
Policlinico San Martino
Genova, 16132
Az. Unità Loc. Socio-Sanitaria 21 -
Legnago, 37045
Spedali Riuniti di Livorno
Livorno, 57100
Fondazione Salvatore Maugeri
Milan, 20138
Asst Santi Paolo E Carlo
Milan, 20142
Osp. dei Colli Monaldi-Cotugno
Naples, 80131
Azienda Sanitaria Ospedale S. Luigi Gonzaga
Orbassano, 10043
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, 90146
Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100
Azienda Unità Sanitaria Locale di Reggio Emilia
Reggio Emilia, 42123
Pol. Universitario Tor Vergata
Roma, 00133
Ospedale Civile Mazzini
Teramo, 64100
ASL 4 di Terni
Terni, 05100

Other trials in Italy

About this study

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

Conditions: Pulmonary Disease, Chronic Obstructive
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Patient's disease perception was evaluated by Brief Illness Perception Questionnaire (B-IPQ) consist 8 questionnaires rated 1 - 10 response scale. Mean total score ranges from 8-80, where a greater score indicated a more threatening view of COPD.
Adherence was measured using Morisky Medication Adherence Scale, 4 items (MMAS-4) questionnaire which consists of 4 questions. Items are summed to give an adherence score ranging from 0 to 4, where a higher score indicated a greater adherence grade.
Patients' health status was measured using the COPD Assessment Test (CAT) questionnaire that consists of 8-items in which patients can choose a score from 0 to 5. The total score ranges from 0 to 40, where a higher score indicated a worst impact of symptoms on the patient's daily activities.
Dyspnea was measured using Modified Medical Research Council Dyspnea Scale (MMRC) with a 0-to-4 grading system. It had 0-to-4 grading system, with higher score indicating a higher level of dyspnea.
Measured: 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.
A regression model was estimated, where the dependent variable was the effectiveness domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables.
Mean is actually estimate of beta values. Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months.
Measured: 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.
A regression model was estimated, where the dependent variable was the convenience domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables.
Mean is actually estimate of beta values. Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months.
Measured: 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.
A regression model was estimated, where the dependent variable was the global satisfaction domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables.
Mean is actually estimate of beta values.Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months.
Measured: Up to 12 months
The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period
Health care resources consumption related to COPD, COPD exacerbations and COPD-drug-related adverse events was computed during observational period in terms of number of (inward and day-hospital) hospitalizations, number of emergency room accesses, number of General Practitioner (GP) visits, specialist visits and laboratory tests or examinations.
Hospitalization (Number Analyzed) - Number of hospitalizations not in ICU during observation period per patient, Emergency room accesses (Number Analyzed) - Number of Emergency room accesses during observation period per patient, Specialist Outpatient Visits (Number Analyzed) - Number of specialist outpatient visits per patient during observation period, GP Visits (Number Analyzed) - Number of general practitioner visits per patient during observation period, Laboratory Tests (Number Analyzed) - Number of tests per patient during observation period.
Measured: Up to 12 months
Correlation Between Patients' Satisfaction and Resource Utilization
Correlation indexes were calculated between treatment satisfaction domain scores of TSQM-9 and healthcare resource consumption at 12-month follow-up visit.
Hospitalization - Number of hospitalizations not in ICU during observation period per patient, Specialist Outpatient - Number of specialist outpatient visits per patient during observation period, E = Effectiveness at 12 months and C = Convenience at 12 months
Measured: 12-month follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Dec 201515 Sep 2017

First posted24 Feb 2016 (estimated)
Study start11 Dec 2015
Primary completion15 Sep 2017
Study completion15 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 401 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02689492
Sponsor's protocol ID: 1237.51
Status last verified: Jul 2019
First submitted: 17 Nov 2015
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 31760881
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.
PubMed 31174106
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.
PubMed 30587957

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SATisfaction and Adherence to COPD Treatment
ClinicalTrials.gov ID: NCT02689492
Acronym / sponsor ID: 1237.51
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 401 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 11 Dec 2015 (actual)
Primary completion: 15 Sep 2017 (actual)
Study completion: 15 Sep 2017 (actual)
First posted: 24 Feb 2016 (estimated)
Results: Posted 28 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 40 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: COPD pts

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period
Time frame: At enrollment visit, 6-month follow-up visit and 12-month follow-up visit.
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.

6 secondary outcomes

Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months
The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period
Time frame: Up to 12 months
Correlation Between Patients' Satisfaction and Resource Utilization
Time frame: 12-month follow-up visit

Results and safety

Results posted to the registry on 28 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total COPD Patients	401	315

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

Time frame: At enrollment visit, 6-month follow-up visit and 12-month follow-up visit.. Mean (Standard Deviation). Unit: Unit on Scale

Measure	Enrollment Visit n = 401	6-month Follow-up n = 360	12-month Follow-up n = 308
Effectiveness (0-100)	64.2 (17.2)	66.2 (16.3)	67.1 (15.1)
Convenience (0-100)	75.8 (15.9)	75.7 (15.8)	76.1 (14.0)
Global satisfaction (0-100)	65.7 (17.1)	67.5 (16.9)	67.3 (15.4)

Population analysed: Full Analysis Set (FAS): FAS includes all enrolled patients evaluable for baseline data analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total COPD Patients	12 of 401 (3%)	0 of 401 (0%)	9 of 401

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31760881Contoli 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.
Derived from this study: PubMed 31174106Corsico 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.
Derived from this study: PubMed 30587957Baiardini 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.
Related InfoLink provided by the sponsor.

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
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Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
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Enrolling by invitationObservational study
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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 20 sites in Italy.

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 6 inclusion and 3 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: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Italy. 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?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period (time frame: At enrollment visit, 6-month follow-up visit and 12-month follow-up visit.). 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 NCT02689492, which also lists 3 linked publications.

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 28 Aug 2019; AzTrials last refreshed its copy on 29 Oct 2026.