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Improving Medication Safety and CVD Risk Factor Control in Kidney Transplant Recipients

9. februar 2018 opdateret af: Medical University of South Carolina

Improving Medication Safety and Cardiovascular Risk Factor Control in Kidney Transplant Recipients

There is a lack of data analyzing the influence of Cardio-vascular Diseases (CVD) risk factor control on graft survival disparities in Black transplant recipients. Studies in the general population indicate that CVD risk factor control is poor in Black patients, leading to higher rates of renal failure and CV events. However, with the exception of hypertension, there is paucity in data demonstrating similar results within transplant recipients. Recent analyses conducted within our transplant program, indicate that CVD risk factors, especially diabetes, are poorly controlled in Black recipients, which likely impacts graft loss. Since these data were collected in a retrospective manner, larger analyses are needed to validate these exploratory findings.

This pilot study is to:

  1. Determine if the study is feasible, as measured by the proportions of enrolled to approached and completed to enrolled.
  2. Measure and compare, at baseline versus the end of the intervention, the medication safety events, including the number of medication errors, medication non-adherence and medication side effects, in patients enrolled in the study
  3. Measure and compare, at baseline versus the end of the intervention, CVD risk factor control, including hypertension, diabetes and dyslipidemia, in patients enrolled in the study
  4. Measure and compare, at baseline versus the end of the intervention, patient reported survey results, in patients enrolled in the study
  5. Determine if the impact of the intervention is more pronounced in Black recipients, as compared to non-Black recipients

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina

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

Beskrivelse

Inclusion Criteria:

  1. At least 18 years of age and able to give informed consent.
  2. Received a first or repeat cadaveric or living donor renal transplant.
  3. Patient has adequate graft function, defined as an estimated glomerular filtration rate (GFR) of at least 20 mL/min, using the 4-variable Modification of Diet in Renal Disease (MDRD) equation.
  4. Patient is at least one year post transplant.
  5. Patient has documented hypertension, defined as a sitting blood pressure of at least 140/90 mmHg or receiving any anti-hypertensive therapy.
  6. Patient has documented diabetes mellitus, defined as a hemoglobin A1c of at least 6.5% or receiving any anti-glycemic medications.
  7. Willing to comply with all study visits.

Exclusion Criteria:

  1. Biopsy proven acute rejection episode that occurred within the past month.
  2. Patients who have received an organ transplant other than a kidney.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in blood pressure values from baseline to end of study
Tidsramme: 6 months
Blood pressure will be assessed using clinic measurements, taken three times, five minutes apart in the same arm and averaged.
6 months
Change in HBA1C values from baseline to end of study
Tidsramme: 6 months
6 months
Change in lipid values from baseline to end of study
Tidsramme: 6 months
6 months
Medication adherence by comparing medication possession ratios (MPR) for the six months prior to enrollment compared to six months during the intervention
Tidsramme: 1 year
1 year
Patient self-reported medication adherence at baseline compared to end of study.
Tidsramme: 6 months
The Morisky 8-item adherence score will be compared from baseline to end of study.
6 months
Number of medication errors assessed at baseline and compared to errors at 6 months
Tidsramme: 6 months
6 months
Medication side effects at baseline compared to end of study.
Tidsramme: 6 months
The Memphis side effect scale will be used to compare side effects from baseline to end of study.
6 months
Patient reported survey results regarding self-care and health knowledge from baseline to end of study
Tidsramme: 6 months
6 months
Patient reported survey results regarding psychosocial status from baseline to end of study
Tidsramme: 6 months
6 months

Samarbejdspartnere og efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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)

1. april 2016

Primær færdiggørelse (Faktiske)

22. januar 2018

Studieafslutning (Faktiske)

22. januar 2018

Datoer for studieregistrering

Først indsendt

14. marts 2016

Først indsendt, der opfyldte QC-kriterier

3. maj 2016

Først opslået (Skøn)

5. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. februar 2018

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00051804

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 .

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