This study aims to evaluate the impact of AbbVie Care 2.0 on adalimumab's compliance, patient reported outcomes and utilization of health resources over 12 months.
Study Type
OBSERVATIONAL
Enrollment
116
Instituto Portugues De Reumatologia /ID# 205963
Lisbon, Lisbon District, Portugal
Centro Hosp de Lisboa Central /ID# 205698
Lisbon, Lisbon District, Portugal
Centro Hospitalar Lisboa Ocidental, EPE /ID# 201328
Lisbon, Lisbon District, Portugal
Centro Hospitalar Lisboa Ocidental, EPE /ID# 201330
Lisbon, Lisbon District, Portugal
CCA Braga - Hospital de Braga /ID# 201322
Braga, Portugal
CCA Braga - Hospital de Braga /ID# 201323
Braga, Portugal
CCA Braga - Hospital de Braga /ID# 201324
Braga, Portugal
Hospital Santo Antonio dos Cap /ID# 205700
Lisbon, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 201335
Lisbon, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 201336
Lisbon, Portugal
...and 5 more locations
Proportion of patients with Medication Possession Ratio (MPR)>=80%
The variable MPR will be used, considering in the numerator the sum of days supply between start of observation (baseline) and last prescription dispensed (including the days of last prescription) and as denominator the number of days elapsed between baseline and last prescription dispensed (including the days of last prescription).
Time frame: Up to 12 months
Mean number of injections administered/ prescribed for adalimumab
This is assessed based on patient diary.
Time frame: Up to 12 months
Assessing Patient's overall satisfaction with AbbVie Care 2.0 program
Patient's overall satisfaction with AbbVie Care 2.0 program is scored at 1: Very good, 2: Good and 3: Less satisfying.
Time frame: At 12 months
Number of Sick Leaves
This is assessed by reviewing work time lost due to other reasons than health problems during previous last seven days.
Time frame: Up to 12 months
Time Spent by the Patient to Refill Prescription
This is assessed by reviewing the work productivity indicator over 12 months.
Time frame: Up to 12 months
Number of Hospital Inpatient Days
This is assessed by reviewing the use of health resources over 12 months.
Time frame: Up to 12 months
Number of Emergency Visits
This is assessed by reviewing the use of health resources over 12 months.
Time frame: Up to 12 months
Assessing Working Status
This is assessed by the proportion of patients employed.
Time frame: Up to 12 months
Proportion of patients with MPR>=80%
The variable MPR will be used, considering in the numerator the sum of days supply between start of observation (baseline) and last prescription dispensed (including the days of last prescription) and as denominator the number of days elapsed between baseline and last prescription dispensed (including the days of last prescription).
Time frame: At Month 6
Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM)-II
This 14-point measure attempts to show that adherence is expected to be related with patients' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. Domains include: Effectiveness, Side effects, Convenience and Global satisfaction.
Time frame: Up to Month 12
Mean Change in EuroQoL (EQ-5D) score
EQ-5D considers five attributes of quality of life evaluation, i.e., mobility, self-care, usual activity, pain/ discomfort, and anxiety/ depression.
Time frame: From Month 0 to Month 12
Number of Complementary Exams/ Techniques
This is assessed by reviewing the use of health resources over 12 months.
Time frame: Up to 12 months
Number of Hospitalizations
This is assessed by reviewing the use of health resources over 12 months.
Time frame: Up to 12 months
Time Spent by the Health Care Providers (HCPs) During Medical Appointments
This is assessed by reviewing the use of health resources over 12 months.
Time frame: Up to 12 months
Mean Change in Patient Activation Measure (PAM-13)
This is a powerful and reliable measure of patient activation. It is 13-item measure used to assess the patient knowledge, skill, and confidence for self-management.
Time frame: From Month 0 to Month 12
Mean Change in Beliefs about Medication Questionnaire (BMQ)
The BMQ comprises two sections: the BMQ-Specific, which assesses representations of medication prescribed for personal use and the BMQ-General, which assesses beliefs about medicines in general. This questionnaire is validated for use in Portugal.
Time frame: From Month 0 to Month 12
Change in Work Productivity and Activity Impairment- General Health (WPAI-GH)
WPA-GH assesses the impact of general health problem on work productivity and daily activities during the previous 7 days.
Time frame: From Month 0 to Month 12
Number of Outpatient Visits (in-office and remote) in Hospital Setting
This is assessed by reviewing the use of health resources over 12 months.
Time frame: Up to 12 months
Number of Days of Sick Leaves
This is assessed by reviewing work time lost due to health problems during previous seven days.
Time frame: Up to 12 months
Proportion of patients who are still on adalimumab after 6 and 12 months
This is used to assess persistence and it could be done using pharmacy refills.
Time frame: Up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.