SATisfaction and Adherence to COPD Treatment

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

SATisfaction and Adherence to COPD Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689492
• Other study ID #: 1237.51
• Status: Completed
• Start date: December 11, 2015
• Est. completion date: September 15, 2017

Study information

• Verified date: July 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 evolution.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: September 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

Inclusion criteria:

1. Patients aged equal or more than 40 years

2. Patients must have a documented diagnosis of chronic obstructive pulmonary disease (COPD)

3. Patients with no exacerbations in the last 3 months

4. Patients requiring regular treatment according to GOLD guidelines, i.e.: undergoing stable pharmacological treatment for COPD since at least 3 months

5. Written informed consent to both participation in the study and privacy form

6. Patients capable of discernment and able to read or write in Italian language.

Exclusion criteria:

1. Patients who are currently participating in a clinical trial on experimental drugs.

2. Patients naïve to pharmacological treatment for COPD

3. Diagnosis of Asthma COPD Overlap Syndrome (ACOS)

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	I.N.R.C.A. - I.R.C.C.S Ospedale Geriatrico Ugo Sestili	Ancona
Italy	Ospedale Reg Umberto Parini	Aosta
Italy	A. O. Giuseppe Moscati	Avellino
Italy	Ospedale Civile di Battipaglia	Battipaglia Salerno
Italy	IRCCS - Istituto Scientifico di Cassano delle Murge	Cassano Murge Bari
Italy	Azienda Ospedaliera Universitaria Arcispedale Sant'Anna	Cona (fe)
Italy	Policlinico San Martino	Genova
Italy	Az. Unità Loc. Socio-Sanitaria 21 -	Legnago
Italy	Spedali Riuniti di Livorno	Livorno
Italy	Asst Santi Paolo E Carlo	Milano
Italy	Fondazione Salvatore Maugeri	Milano
Italy	Osp. dei Colli Monaldi-Cotugno	Napoli
Italy	Azienda Sanitaria Ospedale S. Luigi Gonzaga	Orbassano
Italy	Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello	Palermo
Italy	Fondazione IRCCS Policlinico S. Matteo	Pavia
Italy	Azienda Unità Sanitaria Locale di Reggio Emilia	Reggio Emilia
Italy	Pol. Universitario Tor Vergata	Roma
Italy	Ospedale Civile Mazzini	Teramo
Italy	ASL 4 di Terni	Terni

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At enrollment visit, 6-month follow-up visit and 12-month follow-up visit.
Secondary	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.	At enrollment visit, 6-month follow-up visit and 12-month follow-up visit
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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	12-month follow-up visit

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