An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 20 sites in Italy. Open to participants aged 40 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Boehringer Ingelheim · Observational
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.
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This study's enrollment of 401 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
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COPD pts
Exclusion criteria:
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.
Time frame: At enrollment visit, 6-month follow-up visit and 12-month follow-up visit.
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.
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.
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.
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.
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.
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.
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.
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
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.
Time frame: 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
Time frame: 12-month follow-up visit
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.
| Milestone | Total COPD Patients |
|---|---|
| Started | 401 |
| Completed | 315 |
| Not completed | 86 |
| Withdrew: Lost to follow-up | 61 |
| Withdrew: Withdrawal by subject | 11 |
| Withdrew: Death | 9 |
| Withdrew: Physician decision | 2 |
| Withdrew: Withdrawal/loss to follow-up | 1 |
| Withdrew: Withdrawal/ physician's decision | 1 |
| Withdrew: Other than listed | 1 |
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.
| Unit on Scale | Enrollment Visit | 6-month Follow-up | 12-month Follow-up |
|---|---|---|---|
| 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 |
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.
| Unit on Scale | Enrollment Visit | 6-month Follow-up | 12-month Follow-up |
|---|---|---|---|
| B-IPQ (8-80) | 41.8 ± 11.3 | 42.0 ± 10.0 | 42.6 ± 10.5 |
| MMAS-4 (0-4) | 3.4 ± 0.9 | 3.5 ± 0.9 | 3.5 ± 0.9 |
| CAT score (0-40) | 15.7 ± 7.8 | 15.9 ± 7.6 | 15.1 ± 7.5 |
| Patients' dyspnea (MMRC) | 1.6 ± 1.1 | 1.8 ± 1.1 | 1.7 ± 1.1 |
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.
| Beta coefficient estimate | Total COPD Patients |
|---|---|
| Visit 2 vs Visit 1 | 0.9639 ± 1.1450 |
| Visit 3 vs Visit 1 | 1.8419 ± 1.2970 |
| Age | -0.0566 ± 0.1015 |
| Gender (Female vs Male) | 0.6152 ± 1.8658 |
| Number of exacerbations in the year before Visit 1 | 0.1913 ± 1.0683 |
| FEV1 predicted (%) at enrollment | 0.0924 ± 0.0387 |
| MMAS-4 score class at Visit 1 (Score = 2 vs 4) | -1.7866 ± 2.1787 |
| MMAS-4 score class at Visit 1 (Score = 3 vs 4) | -1.3991 ± 2.0051 |
| CAT score at Visit 1 | -0.2645 ± 0.1137 |
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.
| Beta coefficient estimate | Total COPD Patients |
|---|---|
| Visit 2 vs Visit 1 | -0.1907 ± 1.0026 |
| Visit 3 vs Visit 1 | 0.1130 ± 0.9902 |
| Age | -0.2438 ± 0.0858 |
| Gender (Female vs Male) | 0.1682 ± 1.5588 |
| Number of exacerbations in the year before Visit 1 | -1.0434 ± 0.9070 |
| FEV1 predicted (%) at enrollment | 0.0348 ± 0.0329 |
| MMAS-4 score class at Visit 1 (Score = 2 vs 4) | -5.4461 ± 1.8328 |
| MMAS-4 score class at Visit 1 (Score = 3 vs 4) | -4.2513 ± 1.6786 |
| CAT score at Visit 1 | -0.0782 ± 0.0949 |
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.
| Beta coefficient estimate | Total COPD Patients |
|---|---|
| Visit 2 vs Visit 1 | 2.2165 ± 1.0757 |
| Visit 3 vs Visit 1 | 2.4258 ± 1.1032 |
| Age | -0.1139 ± 0.1005 |
| Gender (Female vs Male) | 1.6246 ± 1.8334 |
| Number of exacerbations in the year before Visit 1 | -0.8055 ± 1.0599 |
| FEV1 predicted (%) at enrollment | 0.0748 ± 0.0385 |
| MMAS-4 score class at Visit 1 (Score = 2 vs 4) | -2.2278 ± 2.1607 |
| MMAS-4 score class at Visit 1 (Score = 3 vs 4) | -5.4749 ± 1.9726 |
| CAT score at Visit 1 | -0.2445 ± 0.1117 |
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.
| Number of events | Total COPD Patients |
|---|---|
| Hospitalization | 0.1 ± 0.4 |
| Emergency room accesses | 0.1 ± 0.2 |
| Specialist Outpatient Visits | 0.2 ± 0.7 |
| GP Visits | 0.4 ± 0.9 |
| Laboratory Tests | 0.7 ± 3.1 |
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
| Spearman's correlation coefficients | Total COPD Patients |
|---|---|
| Specialist Outpatient_E | -0.14945 |
| Hospitalization_C | -0.13233 |
Collected over From signing the informed consent till the end of the study (Visit3 after 12 months +/- 1 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total COPD Patients | 9/401 (2.2%) | 12/401 (3%) | 0/401 (0%) |
| Event | Total COPD Patients |
|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 2/401 |
| DeathGeneral disorders | 2/401 |
| Cardiac failureCardiac disorders | 2/401 |
| Gallbladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/401 |
| Respiratory arrestRespiratory, thoracic and mediastinal disorders | 1/401 |
| Lung neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/401 |
| Acute leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/401 |
| Sudden cardiac deathGeneral disorders | 1/401 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/401 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/401 |
Full Analysis Set (FAS): FAS includes all enrolled patients evaluable for baseline data analysis.
| Age, Continuous(Years) | Total COPD Patients |
|---|---|
| Mean | 71.7 ± 7.6 |
| Sex: Female, Male(Participants) | Total COPD Patients |
|---|---|
| Female | 102 |
| Male | 299 |
| Race (NIH/OMB)(Participants) | Total COPD Patients |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 400 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Pulmonary Disease, Chronic Obstructive→
Boehringer Ingelheim