Impact of an E-learning Tool on Patient Satisfaction, Knowledge and Medication Adherence in Solid Organ Transplantation: A Randomized Controlled Trial
Solid organ transplant recipients (SOTR) must follow complex medication regimens and require a substantial amount of education for effective self-management. The current standard of care for post-transplant medication teaching is a Self Medication education program conducted in hospital by the pharmacist. The Transplant Medication Information Teaching Tool (TMITT) is a web-based e-learning tool for SOTR developed at the Toronto General Hospital. The ability to control the content, sequence, pace and timing of education in order to achieve personal learning objectives, as well as the opportunity for ongoing review and reinforcement of information, may be an attractive, convenient and effective teaching modality.
SOTR will be randomly assigned to receive the standard of care or the standard of care plus the TMITT intervention. Primary objectives are to compare patient satisfaction and medication knowledge between the two groups at baseline and 3 months using modified versions of previously published questionnaires. Medication adherence as measured by a multidimensional approach including both subjective and objective components, will also be compared at 3 months. Our hypothesis is that an education strategy that includes both the standard pharmacist teaching followed by a tailored online e-learning intervention post-discharge will lead to improved patient satisfaction, knowledge and medication adherence.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
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Toronto、Ontario、カナダ、M5G 2N2
- Toronto General Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- all patients undergoing solid organ transplantation at Toronto General Hospital during the study period
Exclusion Criteria:
- non-English speaking/reading
- no internet access at home
- planned discharge to a rehab facility without internet access
- not on a calcineurin inhibitor (CNI) or sirolimus
- attending the Self Medication class on the same day as hospital discharge
- cognitive impairment that precludes participation in Self Medication program (as per the assessment of the transplant pharmacist)
- incapable of providing informed consent
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
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
介入なし:Standard of Care
Patients in the Standard of Care arm receive the usual in-hospital post-transplant medication teaching class led by a transplant pharmacist.
|
|
アクティブコンパレータ:TMITT
Patients in this arm receive the standard of care plus the TMITT educational intervention.
|
Online e-learning tool for post-transplant medication education.
|
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 |
---|---|---|
Change in Medication Knowledge Score from baseline to 3 months
時間枠:Baseline and 3 months
|
Medication Knowledge Score consists of 2 parts - recall of medication regimen and multiple choice knowledge questionnaire.
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Baseline and 3 months
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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 Satisfaction
時間枠:Baseline and 3 months
|
Patient satisfaction with medication information received.
|
Baseline and 3 months
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Medication Adherence
時間枠:3 months
|
Adherence to the immunosuppressant medication regimen is evaluated using the Multidimensional Adherence Classification System.
This consists of patient self-report and measurement of standard deviation of immunosuppressant blood levels.
|
3 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Jennifer Harrison, BScPhm, MSc、University Health Network, Toronto General Hospital
出版物と役立つリンク
一般刊行物
- Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
- Harrison JJ, Badr S, Hamandi B, Kim SJ. Randomized Controlled Trial of a Computer-Based Education Program in the Home for Solid Organ Transplant Recipients: Impact on Medication Knowledge, Satisfaction, and Adherence. Transplantation. 2017 Jun;101(6):1336-1343. doi: 10.1097/TP.0000000000001279.
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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。
固形臓器移植の臨床試験
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AstraZeneca募集Adv Solid Malig - H&N SCC、ATM Pro / Def NSCLC、胃がん、乳がん、卵巣がんスペイン, アメリカ, ベルギー, イギリス, フランス, ハンガリー, カナダ, 大韓民国, オーストラリア