Clinical trial NCT01959308: Adherence to Immunosuppressive Therapy Liver Transplant Recipients
Official title: Adherence to Immunosuppressive Therapy in Adult and Adolescent Liver Transplant Recipients: A Questionnaire Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Focus : To Study the Differences in Patient Compliance to Immunosuppressive Treatments and Patient Preference.
Keywords: Adherence
Compliance
Immunosuppressive Therapy
Liver Transplant
Liver Recipients
Adult
Adolescent
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (males or females age 18 years and above) who are on active follow up at liver transplant clinic at National University Hospital, Singapore.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compliance / Adherence to immunosuppression
timeFrame: 1 year
Secondary outcomes:
measure: Patient preferences on dosing of immunosuppression & associated factors
timeFrame: 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital, Div of Gastroenterology & Hepatology, National University Center for Organ Transplantation
Study officials:
References: