Trial Outcomes & Findings for SATisfaction and Adherence to COPD Treatment (NCT NCT02689492)
NCT ID: NCT02689492
Last Updated: 2019-08-28
Results Overview
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.
COMPLETED
401 participants
At enrollment visit, 6-month follow-up visit and 12-month follow-up visit.
2019-08-28
Participant Flow
This was a multi-center, non-interventional (observational), prospective cohort study based mainly on newly-collected data for Chronic obstructive pulmonary disease (COPD) patients. No treatments were administered to the patients on the protocol basis, since this was a non-interventional study. The total number of enrolled patients was 401.
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
Total COPD Patients
Patients were enrolled (enrollment phase was 10 months) in the SAT (SATisfaction and adherence to COPD treatment) study and they were evaluable for the analyses and follow-up visits were scheduled at 6 and 12 months. All patients had a baseline Treatment Satisfaction Questionnaire- 9 items (TSQM-9) usable for the baseline data analysis and were included in the Full Analysis Set (FAS).
|
|---|---|
|
Overall Study
STARTED
|
401
|
|
Overall Study
COMPLETED
|
315
|
|
Overall Study
NOT COMPLETED
|
86
|
Reasons for withdrawal
| Measure |
Total COPD Patients
Patients were enrolled (enrollment phase was 10 months) in the SAT (SATisfaction and adherence to COPD treatment) study and they were evaluable for the analyses and follow-up visits were scheduled at 6 and 12 months. All patients had a baseline Treatment Satisfaction Questionnaire- 9 items (TSQM-9) usable for the baseline data analysis and were included in the Full Analysis Set (FAS).
|
|---|---|
|
Overall Study
Lost to Follow-up
|
61
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Death
|
9
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal/Loss To Follow-Up
|
1
|
|
Overall Study
Withdrawal/ Physician's Decision
|
1
|
|
Overall Study
Other than listed
|
1
|
Baseline Characteristics
SATisfaction and Adherence to COPD Treatment
Baseline characteristics by cohort
| Measure |
Total COPD Patients
n=401 Participants
Patients were enrolled (enrollment phase was 10 months) in the SAT (SATisfaction and adherence to COPD treatment) study and they were evaluable for the analyses and follow-up visits were scheduled at 6 and 12 months. All patients had a baseline Treatment Satisfaction Questionnaire- 9 items (TSQM-9) usable for the baseline data analysis and were included in the Full Analysis Set (FAS).
|
|---|---|
|
Age, Continuous
|
71.7 Years
STANDARD_DEVIATION 7.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
299 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
400 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: At enrollment visit, 6-month follow-up visit and 12-month follow-up visit.Population: Full Analysis Set (FAS): FAS includes all enrolled patients evaluable for baseline data analysis.
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.
Outcome measures
| Measure |
Enrollment Visit
n=401 Participants
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment) at the enrollment visit. (FAS patients)
|
6-month Follow-up
n=360 Participants
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 6 months.
|
12-month Follow-up
n=308 Participants
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 12 months.
|
|---|---|---|---|
|
The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period
Effectiveness (0-100)
|
64.2 Unit on Scale
Standard Deviation 17.2
|
66.2 Unit on Scale
Standard Deviation 16.3
|
67.1 Unit on Scale
Standard Deviation 15.1
|
|
The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period
Convenience (0-100)
|
75.8 Unit on Scale
Standard Deviation 15.9
|
75.7 Unit on Scale
Standard Deviation 15.8
|
76.1 Unit on Scale
Standard Deviation 14.0
|
|
The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period
Global satisfaction (0-100)
|
65.7 Unit on Scale
Standard Deviation 17.1
|
67.5 Unit on Scale
Standard Deviation 16.9
|
67.3 Unit on Scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: At enrollment visit, 6-month follow-up visit and 12-month follow-up visitPopulation: FAS
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.
Outcome measures
| Measure |
Enrollment Visit
n=401 Participants
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment) at the enrollment visit. (FAS patients)
|
6-month Follow-up
n=360 Participants
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 6 months.
|
12-month Follow-up
n=308 Participants
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 12 months.
|
|---|---|---|---|
|
Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period.
B-IPQ (8-80)
|
41.8 Unit on Scale
Standard Deviation 11.3
|
42.0 Unit on Scale
Standard Deviation 10.0
|
42.6 Unit on Scale
Standard Deviation 10.5
|
|
Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period.
MMAS-4 (0-4)
|
3.4 Unit on Scale
Standard Deviation 0.9
|
3.5 Unit on Scale
Standard Deviation 0.9
|
3.5 Unit on Scale
Standard Deviation 0.9
|
|
Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period.
CAT score (0-40)
|
15.7 Unit on Scale
Standard Deviation 7.8
|
15.9 Unit on Scale
Standard Deviation 7.6
|
15.1 Unit on Scale
Standard Deviation 7.5
|
|
Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period.
Patients' dyspnea (MMRC)
|
1.6 Unit on Scale
Standard Deviation 1.1
|
1.8 Unit on Scale
Standard Deviation 1.1
|
1.7 Unit on Scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: FAS
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.
Outcome measures
| Measure |
Enrollment Visit
n=401 Participants
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment) at the enrollment visit. (FAS patients)
|
6-month Follow-up
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 6 months.
|
12-month Follow-up
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 12 months.
|
|---|---|---|---|
|
The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Visit 2 vs Visit 1
|
0.9639 Beta coefficient estimate
Standard Error 1.1450
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Visit 3 vs Visit 1
|
1.8419 Beta coefficient estimate
Standard Error 1.2970
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Age
|
-0.0566 Beta coefficient estimate
Standard Error 0.1015
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Gender (Female vs Male)
|
0.6152 Beta coefficient estimate
Standard Error 1.8658
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Number of exacerbations in the year before Visit 1
|
0.1913 Beta coefficient estimate
Standard Error 1.0683
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
FEV1 predicted (%) at enrollment
|
0.0924 Beta coefficient estimate
Standard Error 0.0387
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
MMAS-4 score class at Visit 1 (Score = 2 vs 4)
|
-1.7866 Beta coefficient estimate
Standard Error 2.1787
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
MMAS-4 score class at Visit 1 (Score = 3 vs 4)
|
-1.3991 Beta coefficient estimate
Standard Error 2.0051
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
CAT score at Visit 1
|
-0.2645 Beta coefficient estimate
Standard Error 0.1137
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: FAS
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.
Outcome measures
| Measure |
Enrollment Visit
n=401 Participants
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment) at the enrollment visit. (FAS patients)
|
6-month Follow-up
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 6 months.
|
12-month Follow-up
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 12 months.
|
|---|---|---|---|
|
The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Visit 2 vs Visit 1
|
-0.1907 Beta coefficient estimate
Standard Error 1.0026
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Visit 3 vs Visit 1
|
0.1130 Beta coefficient estimate
Standard Error 0.9902
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Age
|
-0.2438 Beta coefficient estimate
Standard Error 0.0858
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Gender (Female vs Male)
|
0.1682 Beta coefficient estimate
Standard Error 1.5588
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Number of exacerbations in the year before Visit 1
|
-1.0434 Beta coefficient estimate
Standard Error 0.9070
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
FEV1 predicted (%) at enrollment
|
0.0348 Beta coefficient estimate
Standard Error 0.0329
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
MMAS-4 score class at Visit 1 (Score = 2 vs 4)
|
-5.4461 Beta coefficient estimate
Standard Error 1.8328
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
MMAS-4 score class at Visit 1 (Score = 3 vs 4)
|
-4.2513 Beta coefficient estimate
Standard Error 1.6786
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
CAT score at Visit 1
|
-0.0782 Beta coefficient estimate
Standard Error 0.0949
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: FAS
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.
Outcome measures
| Measure |
Enrollment Visit
n=401 Participants
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment) at the enrollment visit. (FAS patients)
|
6-month Follow-up
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 6 months.
|
12-month Follow-up
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 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.
Visit 2 vs Visit 1
|
2.2165 Beta coefficient estimate
Standard Error 1.0757
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Visit 3 vs Visit 1
|
2.4258 Beta coefficient estimate
Standard Error 1.1032
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Age
|
-0.1139 Beta coefficient estimate
Standard Error 0.1005
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Gender (Female vs Male)
|
1.6246 Beta coefficient estimate
Standard Error 1.8334
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
Number of exacerbations in the year before Visit 1
|
-0.8055 Beta coefficient estimate
Standard Error 1.0599
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
FEV1 predicted (%) at enrollment
|
0.0748 Beta coefficient estimate
Standard Error 0.0385
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
MMAS-4 score class at Visit 1 (Score = 2 vs 4)
|
-2.2278 Beta coefficient estimate
Standard Error 2.1607
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
MMAS-4 score class at Visit 1 (Score = 3 vs 4)
|
-5.4749 Beta coefficient estimate
Standard Error 1.9726
|
—
|
—
|
|
The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
CAT score at Visit 1
|
-0.2445 Beta coefficient estimate
Standard Error 0.1117
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: FAS
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.
Outcome measures
| Measure |
Enrollment Visit
n=401 Participants
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment) at the enrollment visit. (FAS patients)
|
6-month Follow-up
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 6 months.
|
12-month Follow-up
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 12 months.
|
|---|---|---|---|
|
The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period
Hospitalization
|
0.1 Number of events
Standard Deviation 0.4
|
—
|
—
|
|
The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period
Emergency room accesses
|
0.1 Number of events
Standard Deviation 0.2
|
—
|
—
|
|
The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period
Specialist Outpatient Visits
|
0.2 Number of events
Standard Deviation 0.7
|
—
|
—
|
|
The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period
GP Visits
|
0.4 Number of events
Standard Deviation 0.9
|
—
|
—
|
|
The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period
Laboratory Tests
|
0.7 Number of events
Standard Deviation 3.1
|
—
|
—
|
SECONDARY outcome
Timeframe: 12-month follow-up visitPopulation: FAS
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
Outcome measures
| Measure |
Enrollment Visit
n=401 Participants
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment) at the enrollment visit. (FAS patients)
|
6-month Follow-up
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 6 months.
|
12-month Follow-up
Long-term data on the patients' satisfaction to COPD medical treatments (i.e. pharmacological and not pharmacological treatment)evaluable at 12 months.
|
|---|---|---|---|
|
Correlation Between Patients' Satisfaction and Resource Utilization
Specialist Outpatient_E
|
-0.14945 Spearman's correlation coefficients
|
—
|
—
|
|
Correlation Between Patients' Satisfaction and Resource Utilization
Hospitalization_C
|
-0.13233 Spearman's correlation coefficients
|
—
|
—
|
Adverse Events
Total COPD Patients
Serious adverse events
| Measure |
Total COPD Patients
n=401 participants at risk
Patients were enrolled (enrollment phase was 10 months) in the SAT (SATisfaction and adherence to COPD treatment) study and they were evaluable for the analyses and follow-up visits were scheduled at 6 and 12 months. All patients had a baseline Treatment Satisfaction Questionnaire- 9 items (TSQM-9) usable for the baseline data analysis and were included in the Full Analysis Set (FAS).
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.50%
2/401 • From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.25%
1/401 • From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).
|
|
General disorders
Death
|
0.50%
2/401 • From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.25%
1/401 • From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.25%
1/401 • From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.25%
1/401 • From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).
|
|
General disorders
Sudden cardiac death
|
0.25%
1/401 • From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.25%
1/401 • From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).
|
|
Cardiac disorders
Cardiac failure
|
0.50%
2/401 • From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.25%
1/401 • From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).
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Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER