Adherence to Immunosuppressive Therapy Liver Transplant Recipients (AIM)
Adherence to Immunosuppressive Therapy in Adult and Adolescent Liver Transplant Recipients: A Questionnaire Survey
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Kieron Lim, MD
- Telefonnummer: (65)67726258
- E-post: kieron_lim@nuhs.edu.sg
Studera Kontakt Backup
- Namn: Charlene Soon, BSc
- Telefonnummer: (65)67726120
- E-post: Charlene_SL_SOON@nuhs.edu.sg
Studieorter
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-
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Singapore, Singapore, 119228
- Rekrytering
- National University Hospital, Div of Gastroenterology & Hepatology, National University Center for Organ Transplantation
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Kontakt:
- Kieron Lim, MD
- Telefonnummer: (65)67726258
- E-post: kieron_lim@nuhs.edu.sg
-
Huvudutredare:
- Kieron Lim, MD
-
Underutredare:
- Seng Gee Lim, MD
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Underutredare:
- Krishnakumar Madhavan, MD
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Underutredare:
- Yock Young Dan, MD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Tidsperspektiv: Retrospektiv
Kohorter och interventioner
Grupp / Kohort |
|---|
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Immunosuppressive therapy
Liver Transplant recipients who are receiving various doses and types of immunosuppressive therapy
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Compliance / Adherence to immunosuppression
Tidsram: 1 year
|
|
1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient preferences on dosing of immunosuppression & associated factors
Tidsram: 1 year
|
|
1 year
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- AIM Study
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