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

Kidney Transplantation Clinical Trial

— SMP-NEP  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282124
• Other study ID #: KEK-ZK-Nr. 2011-0411
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: February 2018

Study information

• Verified date: April 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation
• Rental Transplantation

Intervention

Behavioral:
• Self-management program with monthly sessions
Patients participate in 9 sessions during the first 8th month after transplantaiton
• Usual Care, containing one session
Session takes place within the first three months after transplantation

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline BMI at 8 months	BMI	8th month
Secondary	difference of activity between control and intervention group at month 8	differences in steps measured with pedometer (Stepwatch)	month 8
Secondary	difference of activity between control and intervention group at month 12	differences in steps measured with pedometer (Stepwatch)	month 12
Secondary	change from baseline BMI at 12 months	BMI	12th month
Secondary	difference of self-reported adherence between control and intervention group at month 8		month 8
Secondary	difference of self-reported adherence between control and intervention group at month 12		month 12
Secondary	change from baseline LTM at 8 months	LTM measured with Body Composition Analysis	8 months
Secondary	change from baseline LTM at 12 months	LTM measured with Body Composition Analysis	12 months