N/A
N=401
SATisfaction and Adherence to COPD Treatment
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT02689492 ↗Enrolled (actual)
401
Serious AEs
3.0%
Results posted
Aug 2019
Primary outcome: Primary: The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period — 64.2; 66.2; 67.1; 75.8 Unit on Scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period |
64.2; 66.2; 67.1; 75.8; 75.7; 76.1 | — |
| SECONDARY Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. |
41.8; 42.0; 42.6; 3.4; 3.5; 3.5 | — |
| SECONDARY The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. |
0.9639; 1.8419; -0.0566; 0.6152; 0.1913; 0.0924 | — |
| SECONDARY The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. |
-0.1907; 0.1130; -0.2438; 0.1682; -1.0434; 0.0348 | — |
| SECONDARY The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. |
2.2165; 2.4258; -0.1139; 1.6246; -0.8055; 0.0748 | — |
| SECONDARY The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period |
0.1; 0.1; 0.2; 0.4; 0.7 | — |
| SECONDARY Correlation Between Patients' Satisfaction and Resource Utilization |
-0.14945; -0.13233 | — |
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
- 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.
Exclusion criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02689492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.