Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health Service
- Conditions
- Rheumatoid Arthritis (RA)Non-radiographic Axial SpondyloarthritisAnkylosing Spondylitis (AS)Crohn's DiseaseUlcerative Colitis (UC)Psoriatic ArthritisPsoriasis
- Registration Number
- NCT03223012
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- Diagnosed with crohn's disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (SpA) or psoriasis (Pso) according to the treating physician
- Adalimumab was started within 1 month prior to study enrollment
- Adalimumab was introduced based on current clinical practice criteria (i.e., the prescription of adalimumab was clearly separated from the decision to include the participants in this study)
- No prior record of adalimumab treatment
- Adalimumab was administered according to product label
- NaΓ―ve or previously experienced with biologic treatment
- Participant is able and willing to provide written authorization to disclose and use personal health information (informed consent), and to agree that data will be collected and provided to AbbVie
AbbVie Care 2.0 Cohort-specific inclusion criteria:
- Initiated the AbbVie care program within the first month after starting adalimumab.
- Definitive discontinuation of adalimumab before being proposed to participate in the study
- Participated in any clinical experimental research within the 2 months prior to enrollment
- Pregnant or breastfeeding female participants
- Participant not able or not willing to comply with the requirements of this study protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with Medication Possession Ratio (MPR)>=80% Up to 12 months 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).
- Secondary Outcome Measures
Name Time Method Mean number of injections administered/ prescribed for adalimumab Up to 12 months This is assessed based on patient diary.
Assessing Patient's overall satisfaction with AbbVie Care 2.0 program At 12 months Patient's overall satisfaction with AbbVie Care 2.0 program is scored at 1: Very good, 2: Good and 3: Less satisfying.
Number of Sick Leaves Up to 12 months This is assessed by reviewing work time lost due to other reasons than health problems during previous last seven days.
Time Spent by the Patient to Refill Prescription Up to 12 months This is assessed by reviewing the work productivity indicator over 12 months.
Number of Hospital Inpatient Days Up to 12 months This is assessed by reviewing the use of health resources over 12 months.
Number of Hospitalizations Up to 12 months This is assessed by reviewing the use of health resources over 12 months.
Time Spent by the Health Care Providers (HCPs) During Medical Appointments Up to 12 months This is assessed by reviewing the use of health resources over 12 months.
Mean Change in Patient Activation Measure (PAM-13) From Month 0 to Month 12 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.
Number of Emergency Visits Up to 12 months This is assessed by reviewing the use of health resources over 12 months.
Assessing Working Status Up to 12 months This is assessed by the proportion of patients employed.
Proportion of patients with MPR>=80% At Month 6 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).
Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM)-II Up to Month 12 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.
Mean Change in EuroQoL (EQ-5D) score From Month 0 to Month 12 EQ-5D considers five attributes of quality of life evaluation, i.e., mobility, self-care, usual activity, pain/ discomfort, and anxiety/ depression.
Number of Complementary Exams/ Techniques Up to 12 months This is assessed by reviewing the use of health resources over 12 months.
Mean Change in Beliefs about Medication Questionnaire (BMQ) From Month 0 to Month 12 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.
Change in Work Productivity and Activity Impairment- General Health (WPAI-GH) From Month 0 to Month 12 WPA-GH assesses the impact of general health problem on work productivity and daily activities during the previous 7 days.
Number of Outpatient Visits (in-office and remote) in Hospital Setting Up to 12 months This is assessed by reviewing the use of health resources over 12 months.
Number of Days of Sick Leaves Up to 12 months This is assessed by reviewing work time lost due to health problems during previous seven days.
Proportion of patients who are still on adalimumab after 6 and 12 months Up to 12 months This is used to assess persistence and it could be done using pharmacy refills.
Trial Locations
- Locations (15)
Instituto Portugues De Reumatologia /ID# 205963
π΅πΉLisbon, Lisboa, Portugal
CCA Braga - Hospital de Braga /ID# 201323
π΅πΉBraga, Portugal
Centro Hosp de Tondela-Viseu /ID# 203775
π΅πΉViseu, Portugal
Centro Hospitalar de Sao Joao, EPE /ID# 203535
π΅πΉPorto, Portugal
Centro Hosp de Lisboa Central /ID# 205698
π΅πΉLisbon, Lisboa, Portugal
CCA Braga - Hospital de Braga /ID# 201322
π΅πΉBraga, Portugal
Centro Hospitalar Lisboa Ocidental, EPE /ID# 201328
π΅πΉLisbon, Lisboa, Portugal
Centro Hospitalar Lisboa Ocidental, EPE /ID# 201330
π΅πΉLisbon, Lisboa, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 201335
π΅πΉLisboa, Portugal
CCA Braga - Hospital de Braga /ID# 201324
π΅πΉBraga, Portugal
Centro Hospitalar de Sao Joao, EPE /ID# 206278
π΅πΉPorto, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 201336
π΅πΉLisboa, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 201337
π΅πΉLisboa, Portugal
Hospital Santo Antonio dos Cap /ID# 205700
π΅πΉLisbon, Portugal
Centro Hosp de Tondela-Viseu /ID# 203774
π΅πΉViseu, Portugal