Effectiveness of an APN-led Self-management Program in Patients in the First Year After Renal Transplantation

Not Applicable

Completed

• Conditions: Kidney Transplantation; Rental Transplantation
• Interventions: Behavioral: Usual Care, containing one session; Behavioral: Self-management program with monthly sessions

• Registration Number: NCT02282124
• Lead Sponsor: University of Zurich

Brief Summary

The aim of this study is to investigate the effectiveness of the program in patients after renal transplantation using a randomized controlled trial design. Physical, behavioural, and clinical outcomes will be measured at baseline before randomization then 8 and 12 months later.

Detailed Description

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:

1. Compare differences in weight gain between subjects in the IG (intervention group) and in the CG (control group).

2. Compare differences in the amount of physical exercise between subjects in the IG group and the CG.

3. 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-04
• Primary Completion: 2018-01
• Study Completion: 2018-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• received a kidney or a kidney-pancreas transplant in the University Hospital Zürich

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Exclusion Criteria

• unstable psychiatric disorder
• cognitive impairment
• multi-organ transplantation with lung
• liver or heart
• illiteracy
• not able to speak and understand German

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Usual Care, containing one session	-
Intervention	Self-management program with monthly sessions	The intensity of the intervention follows a defined algorithm during the first eight months after renal transplantation. Behaviours are classified in three groups: * Group 1: Patients with optimal behaviour in all three behaviours. * Group 2: Patients with slight deviation (defined) from optimal behaviour in one or more behaviours. * Group 3: Patients with larger deviation (defined) from optimal behaviour in one or more behaviours. 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.

Primary Outcome Measures

Name	Time	Method
change from baseline BMI at 8 months	8th month	BMI

Secondary Outcome Measures

Name	Time	Method
change from baseline LTM at 8 months	8 months	LTM measured with Body Composition Analysis
difference of activity between control and intervention group at month 8	month 8	differences in steps measured with pedometer (Stepwatch)
difference of activity between control and intervention group at month 12	month 12	differences in steps measured with pedometer (Stepwatch)
change from baseline BMI at 12 months	12th month	BMI
difference of self-reported adherence between control and intervention group at month 8	month 8
difference of self-reported adherence between control and intervention group at month 12	month 12
change from baseline LTM at 12 months	12 months	LTM measured with Body Composition Analysis

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland