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Adherence to Immunosuppressive Therapy Liver Transplant Recipients

NCT ID: NCT01959308

Last Updated: 2013-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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

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

Keywords

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Adherence Compliance Immunosuppressive Therapy Liver Transplant Liver Recipients Adult Adolescent

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Immunosuppressive therapy

Liver Transplant recipients who are receiving various doses and types of immunosuppressive therapy

Intervention Type OTHER

Interventions

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Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National University Hospital, Div of Gastroenterology & Hepatology, National University Center for Organ Transplantation

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Kieron Lim, MD

Role: CONTACT

Phone: (65)67726258

Email: [email protected]

Charlene Soon, BSc

Role: CONTACT

Phone: (65)67726120

Email: [email protected]

Facility Contacts

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Kieron Lim, MD

Role: primary

Other Identifiers

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AIM Study

Identifier Type: -

Identifier Source: org_study_id