Focus : To Study the Differences in Patient Compliance to Immunosuppressive Treatments and Patient Preference. Clinical Trial
Official title:
Adherence to Immunosuppressive Therapy in Adult and Adolescent Liver Transplant Recipients: A Questionnaire Survey
Immunosuppressive therapy is fundamental in post-liver transplant patients to prevent and reduce the incidence of acute cellular rejection. Non-compliance to treatment leading to graft rejection is a well-recognized event. This study aims to study the differences in patient compliance to immunosuppressive treatments and patient preference.
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.
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Time Perspective: Retrospective