Adherence to Immunosuppressive Therapy Liver Transplant Recipients (AIM)
Adherence to Immunosuppressive Therapy in Adult and Adolescent Liver Transplant Recipients: A Questionnaire Survey
調査の概要
状態
介入・治療
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Kieron Lim, MD
- 電話番号:(65)67726258
- メール:kieron_lim@nuhs.edu.sg
研究連絡先のバックアップ
- 名前:Charlene Soon, BSc
- 電話番号:(65)67726120
- メール:Charlene_SL_SOON@nuhs.edu.sg
研究場所
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-
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Singapore、シンガポール、119228
- 募集
- National University Hospital, Div of Gastroenterology & Hepatology, National University Center for Organ Transplantation
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コンタクト:
- Kieron Lim, MD
- 電話番号:(65)67726258
- メール:kieron_lim@nuhs.edu.sg
-
主任研究者:
- Kieron Lim, MD
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副調査官:
- Seng Gee Lim, MD
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副調査官:
- Krishnakumar Madhavan, MD
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副調査官:
- Yock Young Dan, MD
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 時間の展望:回顧
コホートと介入
グループ/コホート |
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Immunosuppressive therapy
Liver Transplant recipients who are receiving various doses and types of immunosuppressive therapy
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Compliance / Adherence to immunosuppression
時間枠:1 year
|
|
1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Patient preferences on dosing of immunosuppression & associated factors
時間枠:1 year
|
|
1 year
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。