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
연구 개요
상태
상세 설명
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
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Zurich, 스위스, 8091
- University Hospital Zurich
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 제어
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Session takes place within the first three months after transplantation
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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change from baseline BMI at 8 months
기간: 8th month
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BMI
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8th month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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difference of activity between control and intervention group at month 8
기간: 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
기간: 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
기간: 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
기간: 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
기간: month 12
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month 12
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change from baseline LTM at 8 months
기간: 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
기간: 12 months
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LTM measured with Body Composition Analysis
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Rebecca Spirig, PHD, RN, Nursing Director, Head Office of Nursing and Allied Health Professionals
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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