Effectiveness of an APN-led Self-management Program in Patients in the First Year After Renal Transplantation (SMP-NEP)
Effectiveness of an Advanced Practice Nurse-led Self-management Program on Prevention of Weight Gain, Physical Activity and Medication Adherence in Patients in the First Year After Renal Transplantation
調査の概要
状態
詳細な説明
Renal transplant recipients have to integrate preventive behaviours into their everyday lives. From the literature it is known that patients can only partially adhere to the recommended behaviours. An evidence-based self-management program to support patients in behaviour change was developed with a main focus on prevention of weight gain and increasing physical activity and medication adherence.
The aim of this study is to investigate the effectiveness of the program in patients in the first year after renal transplantation.
The specific aims of this study are:
- Compare differences in weight gain between subjects in the IG (intervention group) and in the CG (control group).
- Compare differences in the amount of physical exercise between subjects in the IG group and the CG.
- Compare differences in self-reported medication adherence between the subjects of the IG group and the CG.
Secondarily, differences in self-reported quality of life, anxiety and depression, and differences in patients' perception of health care provision regarding chronic illness between the subjects of the IG group and the CG will be compared.
Design: Randomised controlled trial, not blinded
Setting and time: The study will take place at the Nephrology Clinic, University Hospital Zürich, from 1 May 2012 through 31 April 2015.
Variables and Measurement: Physical, behavioural, and clinical outcomes will be measured at baseline, before randomization and then 8 and 12 months later. Medication adherence, physical activity, symptoms of depression and anxiety, quality of life and patients' perception of health care provided will be measured with validated questionnaires. Body weight, height, waist to hip ratio and body composition (BCM Fresenius) will be measured at the Nephrology Clinic. Physical activity will be measured with the pedometer StepWatchTM.
Intervention
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
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-
-
Zurich、スイス、8091
- University Hospital Zurich
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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
説明
Inclusion Criteria:
- received a kidney or a kidney-pancreas transplant in the University Hospital Zürich
Exclusion Criteria:
- unstable psychiatric disorder
- cognitive impairment
- multi-organ transplantation with lung
- liver or heart
- illiteracy
- not able to speak and understand German
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
- 主な目的：防止
- 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 |
|---|---|
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他の：コントロール
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Session takes place within the first three months after transplantation
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実験的：Intervention
The intensity of the intervention follows a defined algorithm during the first eight months after renal transplantation. Behaviours are classified in three groups:
All patients (group 1-3) will receive an assessment, education and a monthly reassessment. Patients from group 2 und 3 will receive additionally behavioral education and peer involvement. Patients from group 3 will receive additionally a consilium of specialized healthcare professionals such as a nutritionist, physiotherapist, or psychologist. |
Patients participate in 9 sessions during the first 8th month after transplantaiton
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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 |
|---|---|---|
|
change from baseline BMI at 8 months
時間枠：8th month
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BMI
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8th month
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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 |
|---|---|---|
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difference of activity between control and intervention group at month 8
時間枠：month 8
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differences in steps measured with pedometer (Stepwatch)
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month 8
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difference of activity between control and intervention group at month 12
時間枠：month 12
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differences in steps measured with pedometer (Stepwatch)
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month 12
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change from baseline BMI at 12 months
時間枠：12th month
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BMI
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12th month
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difference of self-reported adherence between control and intervention group at month 8
時間枠：month 8
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month 8
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difference of self-reported adherence between control and intervention group at month 12
時間枠：month 12
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month 12
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change from baseline LTM at 8 months
時間枠：8 months
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LTM measured with Body Composition Analysis
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8 months
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change from baseline LTM at 12 months
時間枠：12 months
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LTM measured with Body Composition Analysis
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12 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Rebecca Spirig, PHD, RN、Nursing Director, Head Office of Nursing and Allied Health Professionals
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
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