- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01959308
Adherence to Immunosuppressive Therapy Liver Transplant Recipients (AIM)
Adherence to Immunosuppressive Therapy in Adult and Adolescent Liver Transplant Recipients: A Questionnaire Survey
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Patient's demographic details such as age, gender, body mass index, education level, language, and occupation will be captured. Clinical details such as significant comorbidities, date of liver transplant, type of transplant (cadaveric or living related), underlying liver disease, type of immunosuppressants, and history of rejection with its details will also be recorded.
Participants will be asked to fill in a Questionnaire aimed to capture socioeconomic and clinical background, as well as the number, type, and dosing schedule of their immunosuppressants. Details and frequency of missed doses, the reason for 'missed doses', and patient's dosing preferences will be the questionnaire to access patient's compliance to medication. A liver transplant coordinator trained to administer the questionnaire will assist patients if required.
The participant will be approached either during their clinic visit or through phone call. For participants who are approached during their clinic session, informed consent process will be conducted in the clinic by the assigned study team member(s). Participants will then complete the questionnaire. Some participants may be on 6-monthly or annual follow-up. For this group of participants, a phone call will be made to ask if they would be keen to participate in this questionnaire study. If they are agreeable, 2 copies of DSRB approved version of informed consent forms together with the questionnaire form will be posted to participants for their completion. Participant will sign the informed consent forms, complete the questionnaire and post the completed documents back to study team members.
The primary and secondary outcome is patient compliance and patient preference, respectively. Besides the type of immunosuppressants, factors associated with outcomes will also be analyzed. Data entry and analysis will be conducted using SAS 9.2. Differences in categorical variables will be analyzed with chi-square test and Fisher's-exact test where appropriate and differences in continuous variables will be analyzed with student T-test. A two-sided analysis will be used and a p value of <0.5 will be considered significant.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Kieron Lim, MD
- Telefonnummer: (65)67726258
- E-post: kieron_lim@nuhs.edu.sg
Studer Kontakt Backup
- Navn: Charlene Soon, BSc
- Telefonnummer: (65)67726120
- E-post: Charlene_SL_SOON@nuhs.edu.sg
Studiesteder
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-
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Singapore, Singapore, 119228
- Rekruttering
- National University Hospital, Div of Gastroenterology & Hepatology, National University Center for Organ Transplantation
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Ta kontakt med:
- Kieron Lim, MD
- Telefonnummer: (65)67726258
- E-post: kieron_lim@nuhs.edu.sg
-
Hovedetterforsker:
- Kieron Lim, MD
-
Underetterforsker:
- Seng Gee Lim, MD
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Underetterforsker:
- Krishnakumar Madhavan, MD
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Underetterforsker:
- Yock Young Dan, MD
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Males or females, 18 years old and above
- Written informed consent must be obtained from subjects prior to study participation
Exclusion Criteria:
- Patients who have not received any immunosuppresants post liver transplant surgery
- Patients who are not willing to participate in this study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tidsperspektiver: Retrospektiv
Kohorter og intervensjoner
Gruppe / Kohort |
---|
Immunosuppressive therapy
Liver Transplant recipients who are receiving various doses and types of immunosuppressive therapy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Compliance / Adherence to immunosuppression
Tidsramme: 1 year
|
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Patient preferences on dosing of immunosuppression & associated factors
Tidsramme: 1 year
|
|
1 year
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- AIM Study
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