Adherence to Immunosuppressive Therapy Liver Transplant Recipients (AIM)

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.

Study Overview

• Status: Unknown
• Conditions: Focus : To Study the Differences in Patient Compliance to Immunosuppressive Treatments and Patient Preference.
• Intervention / Treatment: Other

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Kieron Lim, MD; Phone Number: (65)67726258; Email: kieron_lim@nuhs.edu.sg
• Study Contact Backup: Name: Charlene Soon, BSc; Phone Number: (65)67726120; Email: Charlene_SL_SOON@nuhs.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 119228
    • Recruiting
    • National University Hospital, Div of Gastroenterology & Hepatology, National University Center for Organ Transplantation
    • Contact: Kieron Lim, MD; Phone Number: (65)67726258; Email: kieron_lim@nuhs.edu.sg
    • Principal Investigator: Kieron Lim, MD
    • Sub-Investigator: Seng Gee Lim, MD
    • Sub-Investigator: Krishnakumar Madhavan, MD
    • Sub-Investigator: Yock Young Dan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Immunosuppressive therapy; Liver Transplant recipients who are receiving various doses and types of immunosuppressive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance / Adherence to immunosuppression	Determine compliance to immunosuppressive therapy among liver transplant patients followed up in Liver Transplant Clinic in NUH; Elucidate factors associated with their compliance level	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient preferences on dosing of immunosuppression & associated factors	Determine their preferences on the dosing frequency of immunosuppressive administration; Elucidate factors associated with their preferences.	1 year

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (Estimate): October 10, 2013

Study Record Updates

• Last Update Posted (Estimate): October 10, 2013
• Last Update Submitted That Met QC Criteria: October 8, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Adolescent; Adherence; Adult; Compliance; Immunosuppressive Therapy; Liver Transplant; Liver Recipients
• Other Study ID Numbers: AIM Study