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Completed

NCT Number: NCT02581644

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

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.

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Key information

Conditions

Renal Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Linz, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

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

    Time frame: At patient enrolment

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

    Time frame: At patient enrolment

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

    Time frame: At patient enrolment

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

    Time frame: At patient enrolment

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

    Time frame: At patient enrolment

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

    Time frame: At patient enrolment

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

    Time frame: At patient enrolment

    Objectives: distribution, awareness, utility, utilization and knowledge

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

    Time frame: Day 1

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

    Time frame: Day 1

  10. 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

    Time frame: Day 1

    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

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

    Time frame: Day 1

  12. HCP survey: Mean total score for correct responses

    Time frame: Day 1

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

    Time frame: Day 1

    Objectives: distribution, awareness, utility, utilization and knowledge

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

    Time frame: Upto 4 years

Secondary outcomes

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

    Time frame: At patient enrolment

    Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept

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

    Time frame: At patient enrolment

    Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept

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

    Time frame: At patient enrolment

    Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept

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

    Time frame: Day 1

    Determinants: type of HCP, country, age and gender of HCP years in specialty, number of HCPs in the unit, annual number of patients through the unit, number of patients for whom belatacept was prescribed in the previous 12 months, type of practice, type of institution (academic or non-academic), size of town

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

    Time frame: Upto 4 years

  6. Retrospective chart review study (clinical outcome study) : mean time from symptom onset of infection to receipt of medical therapy

    Time frame: Upto 4 years

  7. Retrospective chart review study (clinical outcome study) : Mean time to diagnosis of graft rejection by biopsy criteria

    Time frame: Upto 4 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Evaluation of the Effectiveness of the Belatacept (Nulojix®) Patient Alert Cards in Patients Following Renal Transplantation in European Economic Area Countries

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2015
Registry last updated
Jun 16, 2017

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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