NCT01959308

Adherence to Immunosuppressive Therapy Liver Transplant Recipients

Adherence to Immunosuppressive Therapy in Adult and Adolescent Liver Transplant Recipients: A Questionnaire Survey

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Focus : To Study the Differences in Patient Compliance to Immunosuppressive Treatments and Patient Preference.

Interventions

Type	Name	Description
OTHER	—

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-10-10
• Last updated: 2013-10-10

Locations

1 site across 1 country: Singapore