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Completed

NCT Number: NCT02282124

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

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.

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Key information

Conditions

Kidney Transplantation Behavior Body Weight Motor Activity Pathological Conditions, Signs and Symptoms Rental Transplantation Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-management program with monthly sessions

Behavioral

Patients participate in 9 sessions during the first 8th month after transplantaiton

Usual Care, containing one session

Behavioral

Session takes place within the first three months after transplantation

Primary outcomes

  1. change from baseline BMI at 8 months

    Time frame: 8th month

    BMI

Secondary outcomes

  1. difference of activity between control and intervention group at month 8

    Time frame: month 8

    differences in steps measured with pedometer (Stepwatch)

  2. difference of activity between control and intervention group at month 12

    Time frame: month 12

    differences in steps measured with pedometer (Stepwatch)

  3. change from baseline BMI at 12 months

    Time frame: 12th month

    BMI

  4. difference of self-reported adherence between control and intervention group at month 8

    Time frame: month 8

  5. difference of self-reported adherence between control and intervention group at month 12

    Time frame: month 12

  6. change from baseline LTM at 8 months

    Time frame: 8 months

    LTM measured with Body Composition Analysis

  7. change from baseline LTM at 12 months

    Time frame: 12 months

    LTM measured with Body Composition Analysis

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: SMP-NEP

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Nov 4, 2014
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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