NCT02282124

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Kidney Transplantation
• Rental Transplantation

Interventions

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

Timeline

• Start date: 2012-05-01
• Primary completion: 2018-01-01
• Completion: 2018-02-01
• First posted: 2014-11-04
• Last updated: 2021-05-03

Locations

1 site across 1 country: Switzerland