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Completed

NCT Number: NCT03223012

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

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.

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Key information

Conditions

Crohn's Disease Ankylosing Spondylitis (AS) Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Colitis Colitis, Ulcerative Colonic Diseases Connective Tissue Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Non-Radiographic Axial Spondyloarthritis Psoriasis Psoriatic Arthritis Rheumatic Diseases Rheumatoid Arthritis (RA) Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Ulcerative Colitis (UC)

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Hosp de Lisboa Central /ID# 205698, Lisbon, Lisbon District, Portugal

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of patients with Medication Possession Ratio (MPR)>=80%

    Time frame: 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 outcomes

  1. Mean number of injections administered/ prescribed for adalimumab

    Time frame: Up to 12 months

    This is assessed based on patient diary.

  2. Assessing Patient's overall satisfaction with AbbVie Care 2.0 program

    Time frame: 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.

  3. Number of Sick Leaves

    Time frame: Up to 12 months

    This is assessed by reviewing work time lost due to other reasons than health problems during previous last seven days.

  4. Time Spent by the Patient to Refill Prescription

    Time frame: Up to 12 months

    This is assessed by reviewing the work productivity indicator over 12 months.

  5. Number of Hospital Inpatient Days

    Time frame: Up to 12 months

    This is assessed by reviewing the use of health resources over 12 months.

  6. Number of Emergency Visits

    Time frame: Up to 12 months

    This is assessed by reviewing the use of health resources over 12 months.

  7. Assessing Working Status

    Time frame: Up to 12 months

    This is assessed by the proportion of patients employed.

  8. Proportion of patients with MPR>=80%

    Time frame: 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).

  9. Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM)-II

    Time frame: 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.

  10. Mean Change in EuroQoL (EQ-5D) score

    Time frame: 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.

  11. Number of Complementary Exams/ Techniques

    Time frame: Up to 12 months

    This is assessed by reviewing the use of health resources over 12 months.

  12. Number of Hospitalizations

    Time frame: Up to 12 months

    This is assessed by reviewing the use of health resources over 12 months.

  13. Time Spent by the Health Care Providers (HCPs) During Medical Appointments

    Time frame: Up to 12 months

    This is assessed by reviewing the use of health resources over 12 months.

  14. Mean Change in Patient Activation Measure (PAM-13)

    Time frame: 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.

  15. Mean Change in Beliefs about Medication Questionnaire (BMQ)

    Time frame: 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.

  16. Change in Work Productivity and Activity Impairment- General Health (WPAI-GH)

    Time frame: 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.

  17. Number of Outpatient Visits (in-office and remote) in Hospital Setting

    Time frame: Up to 12 months

    This is assessed by reviewing the use of health resources over 12 months.

  18. Number of Days of Sick Leaves

    Time frame: Up to 12 months

    This is assessed by reviewing work time lost due to health problems during previous seven days.

  19. Proportion of patients who are still on adalimumab after 6 and 12 months

    Time frame: Up to 12 months

    This is used to assess persistence and it could be done using pharmacy refills.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Post-marketing Prospective, Observational Cohort Study to Evaluate the Impact of AbbVie Care Patient Support Program on Compliance With Adalimumab, Patient Reported Outcomes and Health Resource Utilization in Inflammatory Bowel Diseases, Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis and Psoriasis in Portugal

Acronym: IMPROVE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 19, 2017
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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