Adherence to Immunosuppressive Therapy Liver Transplant Recipients

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

— AIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01959308
• Other study ID #: AIM Study
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2013
• Last updated: October 8, 2013
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: October 2013
• Source: National University Hospital, Singapore
• Contact: Kieron Lim, MD
• Phone: (65)67726258
• Email: kieron_lim[@]nuhs.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Other:
• N.A.

Locations

Country	Name	City	State
Singapore	National University Hospital, Div of Gastroenterology & Hepatology, National University Center for Organ Transplantation	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No