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

Completed

• Conditions: Rheumatoid Arthritis (RA); Non-radiographic Axial Spondyloarthritis; Ankylosing Spondylitis (AS); Crohn's Disease; Ulcerative Colitis (UC); Psoriatic Arthritis; Psoriasis

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-19
• Study Start: 2017-11-15
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• 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
• Naïve 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.

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Exclusion Criteria

• 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.

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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; 🇵🇹 Lisbon, Lisboa, Portugal

CCA Braga - Hospital de Braga /ID# 201323; 🇵🇹 Braga, Portugal

Centro Hosp de Tondela-Viseu /ID# 203775; 🇵🇹 Viseu, Portugal

Centro Hospitalar de Sao Joao, EPE /ID# 203535; 🇵🇹 Porto, Portugal

Centro Hosp de Lisboa Central /ID# 205698; 🇵🇹 Lisbon, Lisboa, Portugal

CCA Braga - Hospital de Braga /ID# 201322; 🇵🇹 Braga, Portugal

Centro Hospitalar Lisboa Ocidental, EPE /ID# 201328; 🇵🇹 Lisbon, Lisboa, Portugal

Centro Hospitalar Lisboa Ocidental, EPE /ID# 201330; 🇵🇹 Lisbon, Lisboa, Portugal

Centro Hospitalar Lisboa Norte, EPE /ID# 201335; 🇵🇹 Lisboa, Portugal

CCA Braga - Hospital de Braga /ID# 201324; 🇵🇹 Braga, Portugal

Centro Hospitalar de Sao Joao, EPE /ID# 206278; 🇵🇹 Porto, Portugal

Centro Hospitalar Lisboa Norte, EPE /ID# 201336; 🇵🇹 Lisboa, Portugal

Centro Hospitalar Lisboa Norte, EPE /ID# 201337; 🇵🇹 Lisboa, Portugal

Hospital Santo Antonio dos Cap /ID# 205700; 🇵🇹 Lisbon, Portugal

Centro Hosp de Tondela-Viseu /ID# 203774; 🇵🇹 Viseu, Portugal