Adherence to Immunosuppressive Therapy Liver Transplant Recipients (AIM)
Adherence to Immunosuppressive Therapy in Adult and Adolescent Liver Transplant Recipients: A Questionnaire Survey
研究概览
地位
干预/治疗
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习地点
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-
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Singapore、新加坡、119228
- 招聘中
- National University Hospital, Div of Gastroenterology & Hepatology, National University Center for Organ Transplantation
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接触：
- Kieron Lim, MD
- 电话号码：(65)67726258
- 邮箱：kieron_lim@nuhs.edu.sg
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首席研究员：
- Kieron Lim, MD
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副研究员：
- Seng Gee Lim, MD
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副研究员：
- Krishnakumar Madhavan, MD
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副研究员：
- Yock Young Dan, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的？
设计细节
- 时间观点：追溯
队列和干预
团体/队列 |
|---|
|
Immunosuppressive therapy
Liver Transplant recipients who are receiving various doses and types of immunosuppressive therapy
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Compliance / Adherence to immunosuppression
大体时间：1 year
|
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient preferences on dosing of immunosuppression & associated factors
大体时间：1 year
|
|
1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.