SATisfaction and Adherence to COPD Treatment
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT02689492
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 401
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period 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.
- Secondary Outcome Measures
Name Time Method The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period Up to 12 months 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.Correlation Between Patients' Satisfaction and Resource Utilization 12-month follow-up visit 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 monthsMeasurements 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 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.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 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.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 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.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 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.
Trial Locations
- Locations (20)
Asst Santi Paolo E Carlo
🇮🇹Milano, Italy
Ospedale Reg Umberto Parini
🇮🇹Aosta, Italy
ASL 4 di Terni
🇮🇹Terni, Italy
Az. Unità Loc. Socio-Sanitaria 21 -
🇮🇹Legnago, Italy
IRCCS - Istituto Scientifico di Cassano delle Murge
🇮🇹Cassano Murge Bari, Italy
Fondazione Salvatore Maugeri
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
🇮🇹Cona (fe), Italy
Policlinico San Martino
🇮🇹Genova, Italy
Osp. dei Colli Monaldi-Cotugno
🇮🇹Napoli, Italy
Pol. Universitario Tor Vergata
🇮🇹Roma, Italy
Fondazione IRCCS Policlinico S. Matteo
🇮🇹Pavia, Italy
I.N.R.C.A. - I.R.C.C.S Ospedale Geriatrico Ugo Sestili
🇮🇹Ancona, Italy
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
Ospedale Civile di Battipaglia
🇮🇹Battipaglia Salerno, Italy
A. O. Giuseppe Moscati
🇮🇹Avellino, Italy
Spedali Riuniti di Livorno
🇮🇹Livorno, Italy
Azienda Sanitaria Ospedale S. Luigi Gonzaga
🇮🇹Orbassano, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
🇮🇹Palermo, Italy
Azienda Unità Sanitaria Locale di Reggio Emilia
🇮🇹Reggio Emilia, Italy
Ospedale Civile Mazzini
🇮🇹Teramo, Italy