- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02763943
Improving Medication Safety and CVD Risk Factor Control in Kidney Transplant Recipients
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:
- Determine if the study is feasible, as measured by the proportions of enrolled to approached and completed to enrolled.
- 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
- 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
- Measure and compare, at baseline versus the end of the intervention, patient reported survey results, in patients enrolled in the study
- Determine if the impact of the intervention is more pronounced in Black recipients, as compared to non-Black recipients
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
South Carolina
-
Charleston, South Carolina, Stati Uniti, 29425
- Medical University of South Carolina
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- At least 18 years of age and able to give informed consent.
- Received a first or repeat cadaveric or living donor renal transplant.
- 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.
- Patient is at least one year post transplant.
- Patient has documented hypertension, defined as a sitting blood pressure of at least 140/90 mmHg or receiving any anti-hypertensive therapy.
- Patient has documented diabetes mellitus, defined as a hemoglobin A1c of at least 6.5% or receiving any anti-glycemic medications.
- Willing to comply with all study visits.
Exclusion Criteria:
- Biopsy proven acute rejection episode that occurred within the past month.
- Patients who have received an organ transplant other than a kidney.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in blood pressure values from baseline to end of study
Lasso di tempo: 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
Lasso di tempo: 6 months
|
6 months
|
|
|
Change in lipid values from baseline to end of study
Lasso di tempo: 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
Lasso di tempo: 1 year
|
1 year
|
|
|
Patient self-reported medication adherence at baseline compared to end of study.
Lasso di tempo: 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
Lasso di tempo: 6 months
|
6 months
|
|
|
Medication side effects at baseline compared to end of study.
Lasso di tempo: 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
Lasso di tempo: 6 months
|
6 months
|
|
|
Patient reported survey results regarding psychosocial status from baseline to end of study
Lasso di tempo: 6 months
|
6 months
|
Collaboratori e investigatori
Collaboratori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pro00051804
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .