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

14. juni 2017 opdateret af: Bristol-Myers Squibb

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

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

63

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Besançon, Frankrig, 25030
        • Local Institution
      • Brest, Frankrig, 29200
        • CHU Brest Hopital la Cavale Blanche
      • Burdeux, Frankrig, 33000
        • CHU Bordeaux Hôpital Pellegrin
      • Clermont-Ferrand, Frankrig, 63000
        • CHU Clemont Ferrand
      • Créteil, Frankrig, 94000
        • APHP Hôpital Henri Mondor
      • Le Kremlin-Bicêtre, Frankrig, 94270
        • Local Institution
      • Toulouse, Frankrig, 31059
        • CHU Toulouse Hopital Rangueli
      • Tours, Frankrig, 37000
        • Chu Tours Hopital Bretonneau
  • Sverige
      • Uppsala, Sverige, 75185
        • Local Institution
  • Tyskland
      • Dresden, Tyskland, 1307
        • Local Institution
      • Kiel, Tyskland, 24105
        • Local Institution
      • Mannheim, Tyskland, 68167
        • UK Mannheim
  • Østrig
      • Linz, Østrig, A-4020
        • Local Institution
      • Vienna, Østrig, A-1090
        • Local Institution

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient survey: Mean scores for correct responses for questions grouped by objectives
Tidsramme: At patient enrolment
Objectives: distribution, awareness, utility, utilization and knowledge
At patient enrolment
HCP survey: Mean total score for correct responses
Tidsramme: Day 1
Day 1
HCP survey: Mean scores for correct responses for questions grouped by objectives
Tidsramme: Day 1
Objectives: distribution, awareness, utility, utilization and knowledge
Day 1
Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC
Tidsramme: At patient enrolment
At patient enrolment
Patient survey : Proportion of patients treated with belatacept who have received the PAC
Tidsramme: At patient enrolment
At patient enrolment
Patient survey : Proportion of patients who have utilised the PAC, and the extent of its use
Tidsramme: At patient enrolment
At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of belatacept treatment
Tidsramme: At patient enrolment
At patient enrolment
Patient survey: HCP-patient communication based on responses to specific questions
Tidsramme: At patient enrolment
At patient enrolment
Patient survey: Proportion of patients with correct responses to behavioral questions
Tidsramme: At patient enrolment
At patient enrolment
HCP survey: Proportion of HCPs who prescribe or administer belatacept in nephrology centres who are aware of the PAC
Tidsramme: Day 1
Day 1
HCP survey: Proportion of HCPs who have utilised the PAC, and the extent of its use
Tidsramme: Day 1
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
Tidsramme: 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
Day 1
HCP survey: Behavior of HCPs based on responses to behavioral questions
Tidsramme: Day 1
Day 1
Retrospective chart review study (clinical outcome study): Proportion of serious infections
Tidsramme: Upto 4 years
Upto 4 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major determinants of patients knowledge of the key messages contained in the belatacept PAC based on data collected in the patient questionnaire
Tidsramme: At patient enrolment
Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept
At patient enrolment
Major determinants of understanding the key messages contained in the PAC based on data collected in the patient questionnaire
Tidsramme: At patient enrolment
Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept
At patient enrolment
Major determinants of implementation regarding the key messages contained in the PAC based on data collected in the patient questionnaire
Tidsramme: At patient enrolment
Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept
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
Tidsramme: 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
Day 1
Retrospective chart review study (clinical outcome study) : proportion of infections leading to discontinuation
Tidsramme: Upto 4 years
Upto 4 years
Retrospective chart review study (clinical outcome study) : mean time from symptom onset of infection to receipt of medical therapy
Tidsramme: Upto 4 years
Upto 4 years
Retrospective chart review study (clinical outcome study) : Mean time to diagnosis of graft rejection by biopsy criteria
Tidsramme: Upto 4 years
Upto 4 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. november 2016

Primær færdiggørelse (Faktiske)

19. maj 2017

Studieafslutning (Faktiske)

19. maj 2017

Datoer for studieregistrering

Først indsendt

28. september 2015

Først indsendt, der opfyldte QC-kriterier

20. oktober 2015

Først opslået (Skøn)

21. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IM103-367

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Nyretransplantation

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner