NCT02581644

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
4 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 29, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

September 28, 2015

Last Update Submit

June 14, 2017

Conditions

Renal Transplant

Outcome Measures

Primary Outcomes (14)

  • Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC

    At patient enrolment

  • Patient survey : Proportion of patients treated with belatacept who have received the PAC

    At patient enrolment

  • Patient survey : Proportion of patients who have utilised the PAC, and the extent of its use

    At patient enrolment

  • Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of belatacept treatment

    At patient enrolment

  • Patient survey: HCP-patient communication based on responses to specific questions

    At patient enrolment

  • Patient survey: Proportion of patients with correct responses to behavioral questions

    At patient enrolment

  • Patient survey: Mean scores for correct responses for questions grouped by objectives

    Objectives: distribution, awareness, utility, utilization and knowledge

    At patient enrolment

  • HCP survey: Proportion of HCPs who prescribe or administer belatacept in nephrology centres who are aware of the PAC

    Day 1

  • HCP survey: Proportion of HCPs who have utilised the PAC, and the extent of its use

    Day 1

  • HCP survey: Levels of HCPs' knowledge and comprehension related to the important identified risks of infections and the need to screen for specific infection prior to initiating or administering belatacept

    The percentage of HCPs with responses to each question in the HCP questionnaire that would indicate effectiveness of the PAC will be determined: who are aware of the PAC, use the PAC, level of knowledge and comprehension of the risks and mean scores for correct responses

    Day 1

  • HCP survey: Behavior of HCPs based on responses to behavioral questions

    Day 1

  • HCP survey: Mean total score for correct responses

    Day 1

  • HCP survey: Mean scores for correct responses for questions grouped by objectives

    Objectives: distribution, awareness, utility, utilization and knowledge

    Day 1

  • Retrospective chart review study (clinical outcome study): Proportion of serious infections

    Upto 4 years

Secondary Outcomes (7)

  • Major determinants of patients knowledge of the key messages contained in the belatacept PAC based on data collected in the patient questionnaire

    At patient enrolment

  • Major determinants of understanding the key messages contained in the PAC based on data collected in the patient questionnaire

    At patient enrolment

  • Major determinants of implementation regarding the key messages contained in the PAC based on data collected in the patient questionnaire

    At patient enrolment

  • Determinants of Health Care Professional (HCP) understanding and implementation regarding key messages contained in the PAC based on data collected in the patient questionnaire

    Day 1

  • Retrospective chart review study (clinical outcome study) : proportion of infections leading to discontinuation

    Upto 4 years

  • +2 more secondary outcomes

Study Arms (3)

Patients survey

Adult patients treated with belatacept for renal transplantation

HCP survey

HCP with at least 1 patient taking belatacept

Retrospective chart review study

Adult patients treated with belatacept for renal transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort 1: Patient enrolled by physicians based in hospital and physician renal units Cohort 2: Physicians and nurses based in hospital and physician renal units Cohort 3: Patient enrolled by physicians based in hospital and physician renal units

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Local Institution

Linz, A-4020, Austria

Location

Local Institution

Vienna, A-1090, Austria

Location

Local Institution

Besançon, 25030, France

Location

CHU Brest Hopital La Cavale Blanche

Brest, 29200, France

Location

CHU Bordeaux Hopital Pellegrin

Burdeux, 33000, France

Location

CHU Clemont Ferrand

Clermont-Ferrand, 63000, France

Location

APHP Hopital Henri Mondor

Créteil, 94000, France

Location

Local Institution

Le Kremlin-Bicêtre, 94270, France

Location

CHU Toulouse Hopital Rangueli

Toulouse, 31059, France

Location

CHU Tours Hopital Bretonneau

Tours, 37000, France

Location

Local Institution

Dresden, 1307, Germany

Location

Local Institution

Kiel, 24105, Germany

Location

UK Mannheim

Mannheim, 68167, Germany

Location

Local Institution

Uppsala, 75185, Sweden

Location

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 21, 2015

Study Start

November 29, 2016

Primary Completion

May 19, 2017

Study Completion

May 19, 2017

Last Updated

June 16, 2017

Record last verified: 2017-06

Locations

FR(8)AU(2)SE(1)DE(3)