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Crohn's DiseaseIMPROVENCT03223012

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

An observational study of Crohn's Disease and Ulcerative Colitis (UC), run by AbbVie at 15 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
How many people
116 participants
Where
15 sitesPortugal
Study dates
15 Nov 2017to 28 Feb 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants receiving adalimumab in routine clinical practice in Portugal

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Portugal15 sites

  • CCA Braga - Hospital de Braga /ID# 201322

    Braga, 4710-243

  • CCA Braga - Hospital de Braga /ID# 201323

    Braga, 4710-243

  • CCA Braga - Hospital de Braga /ID# 201324

    Braga, 4710-243

  • Instituto Portugues De Reumatologia /ID# 205963

    Lisbon, Lisbon District, 1050-034

  • Centro Hosp de Lisboa Central /ID# 205698

    Lisbon, Lisbon District, 1169-050

  • Centro Hospitalar Lisboa Ocidental, EPE /ID# 201328

    Lisbon, Lisbon District, 1349-019

  • Centro Hospitalar Lisboa Ocidental, EPE /ID# 201330

    Lisbon, Lisbon District, 1349-019

  • Hospital Santo Antonio dos Cap /ID# 205700

    Lisbon, 1150-069

  • Centro Hospitalar Lisboa Norte, EPE /ID# 201335

    Lisbon, 1649-035

  • Centro Hospitalar Lisboa Norte, EPE /ID# 201336

    Lisbon, 1649-035

  • Centro Hospitalar Lisboa Norte, EPE /ID# 201337

    Lisbon, 1649-035

  • Centro Hospitalar de Sao Joao, EPE /ID# 203535

    Porto, 4200-319

  • Centro Hospitalar de Sao Joao, EPE /ID# 206278

    Porto, 4200-319

  • Centro Hosp de Tondela-Viseu /ID# 203774

    Viseu, 3504 - 509

  • Centro Hosp de Tondela-Viseu /ID# 203775

    Viseu, 3504 - 509

Other trials in Portugal

About this study

Official 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

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.

Keywords
Adalimumab, Humira®, AbbVie patient care support program, Psoriasis, Axial Spondyloarthritis, Rheumatoid Arthritis, Ulcerative Colitis
Medical subject headings
Crohn Disease, Colitis, Ulcerative, Arthritis, Rheumatoid, Arthritis, Psoriatic, Psoriasis, Spondylitis, Ankylosing, Non-Radiographic Axial Spondyloarthritis, Axial Spondyloarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03223012
Study groupRoleWhat they receive
Participants not included in the AbbVie care programParticipants receiving adalimumab not included in the AbbVie care patient support program.
Participants included in the AbbVie care programParticipants receiving adalimumab included in the AbbVie care patient support program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Up to 12 months

Secondary outcomes (19)

  1. Mean number of injections administered/ prescribed for adalimumab

    This is assessed based on patient diary.

    Measured: Up to 12 months

  2. 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.

    Measured: At 12 months

  3. Number of Sick Leaves

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

    Measured: Up to 12 months

  4. Time Spent by the Patient to Refill Prescription

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

    Measured: Up to 12 months

  5. Number of Hospital Inpatient Days

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

    Measured: Up to 12 months

  6. Number of Emergency Visits

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

    Measured: Up to 12 months

  7. Assessing Working Status

    This is assessed by the proportion of patients employed.

    Measured: Up to 12 months

  8. 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).

    Measured: At Month 6

  9. 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.

    Measured: Up to Month 12

  10. 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.

    Measured: From Month 0 to Month 12

  11. Number of Complementary Exams/ Techniques

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

    Measured: Up to 12 months

  12. Number of Hospitalizations

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

    Measured: Up to 12 months

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

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

    Measured: Up to 12 months

  14. 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.

    Measured: From Month 0 to Month 12

  15. 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.

    Measured: From Month 0 to Month 12

  16. 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.

    Measured: From Month 0 to Month 12

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

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

    Measured: Up to 12 months

  18. Number of Days of Sick Leaves

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

    Measured: Up to 12 months

  19. 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.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2017
  2. Study start15 Nov 2017
  3. Primary completion28 Feb 2019
  4. Study completion28 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03223012
Sponsor's protocol ID
P16-321
Acronym
IMPROVE
Status last verified
Feb 2020
First submitted
18 Jul 2017
Last updated
24 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease and Ulcerative Colitis (UC), run by AbbVie at 15 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with Medication Possession Ratio (MPR)>=80% (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03223012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.

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