SATisfaction and adherence to COPD treatment

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes

  Healthcare resource utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Disease awareness and treatment satisfaction
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Age groups:
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  400

Study design details

• Study design:
  Multi-center, non-interventional (observational), prospective cohort study based mainly on newly-collected data.
• Main study objective:
  To describe the patients’ satisfaction to COPD medical treatments (by means of the TSQM9) during a 12-month observation period (namely, at enrolment, and after 6 and 12 months) in real- world setting
• Setting:
  20 Italian Pneumology Centres.
• Outcomes:
  Patient Reported Outcomes Questionnaires/scales (filled in by patient or the investigator): Treatment Satisfaction Questionnaire, 9 items (TSQM-9), Brief Illness Perception Questionnaire (B-IPQ), COPD Assessment Test (CAT), Modified Medical Research Council Dyspnea Scale (MMRC), Morisky Medication-Taking Adherence Scale, Awareness structured interview (COPD awareness questionnaire).;
• Data analysis plan:
  Descriptive analysis will be means, medians, quantiles, proportions (with their respective 95% confidence intervals and SE when relevant) and contingency tables according to the nature of the variables. As a dispersion measurement the standard deviation and the interquartile range will be calculated.The statistical analysis will be done on all evaluable patients i.e. patients who enter the study without inclusion-exclusion criteria violations and with at least one TSQM-9 domain score (effectiveness, convenience and global satisfaction) calculated. Patients with missing values will not be excluded from the analysis, their data will not be replaced, frequency of missing data will be given for all analyzed variables. Lost to follow up patients will be analyzed until their last available visit.