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Adherence to Immunosuppressive Therapy Liver Transplant Recipients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01959308
Acronym
AIM
Enrollment
100
Registered
2013-10-10
Start date
2013-06-30
Completion date
2014-06-30
Last updated
2013-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Sponsors

National University Hospital, Singapore
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Compliance / Adherence to immunosuppression1 year1. Determine compliance to immunosuppressive therapy among liver transplant patients followed up in Liver Transplant Clinic in NUH 2. Elucidate factors associated with their compliance level

Secondary

MeasureTime frameDescription
Patient preferences on dosing of immunosuppression & associated factors1 year1. Determine their preferences on the dosing frequency of immunosuppressive administration 2. Elucidate factors associated with their preferences.

Countries

Singapore

Contacts

Primary ContactKieron Lim, MD
kieron_lim@nuhs.edu.sg(65)67726258
Backup ContactCharlene Soon, BSc
Charlene_SL_SOON@nuhs.edu.sg(65)67726120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026