Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries

NCT ID: NCT02581644

Last Updated: 2017-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-29

Study Completion Date

2017-05-19

Brief Summary

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The purpose of the study is to determine a) if the implementation of belatacept patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

Detailed Description

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3 sub studies: 2 Cross-Sectional and 1 retrospective chart review

Conditions

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Renal Transplant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients survey

Adult patients treated with belatacept for renal transplantation

No interventions assigned to this group

HCP survey

HCP with at least 1 patient taking belatacept

No interventions assigned to this group

Retrospective chart review study

Adult patients treated with belatacept for renal transplantation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient survey (cohort 1):
* Patients has taken belatacept within the previous 3 months for renal transplantation
* Patient is over 18 years of age
* HCP survey (cohort 2):
* Physician or nurses working in nephrology centers, with at least 1 patient taking belatacept in the previous 6 months for renal transplantation (by prescribing, administering or by follow up)
* Retrospective chart review study (cohort 3):
* Patient survey questionnaire received, Informed Consent Form (ICF) signed (if required)

Exclusion Criteria

* Patient survey:
* Patient has participated in a clinical trial for their renal condition in the previous 12 months
* Currently an employee of BMS
* HCP survey:
* Physicians or nurse who have recruited patients for the Patient survey
* Currently an employee of BMS
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Linz, , Austria

Site Status

Local Institution

Vienna, , Austria

Site Status

Local Institution

Besançon, , France

Site Status

CHU Brest Hopital La Cavale Blanche

Brest, , France

Site Status

CHU Bordeaux Hopital Pellegrin

Burdeux, , France

Site Status

CHU Clemont Ferrand

Clermont-Ferrand, , France

Site Status

APHP Hopital Henri Mondor

Créteil, , France

Site Status

Local Institution

Le Kremlin-Bicêtre, , France

Site Status

CHU Toulouse Hopital Rangueli

Toulouse, , France

Site Status

CHU Tours Hopital Bretonneau

Tours, , France

Site Status

Local Institution

Dresden, , Germany

Site Status

Local Institution

Kiel, , Germany

Site Status

UK Mannheim

Mannheim, , Germany

Site Status

Local Institution

Uppsala, , Sweden

Site Status

Countries

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Austria France Germany Sweden

Related Links

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Other Identifiers

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IM103-367

Identifier Type: -

Identifier Source: org_study_id

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