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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation; Rental Transplantation
• Intervention / Treatment: Behavioral: Self-management program with monthly sessions; Behavioral: Usual Care, containing one session

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

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control	Behavioral: Usual Care, containing one session; Session takes place within the first three months after transplantation
Experimental: Intervention; 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.	Behavioral: Self-management program with monthly sessions; Patients participate in 9 sessions during the first 8th month after transplantaiton

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline BMI at 8 months	BMI	8th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference of activity between control and intervention group at month 8	differences in steps measured with pedometer (Stepwatch)	month 8
difference of activity between control and intervention group at month 12	differences in steps measured with pedometer (Stepwatch)	month 12
change from baseline BMI at 12 months	BMI	12th month
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 8 months	LTM measured with Body Composition Analysis	8 months
change from baseline LTM at 12 months	LTM measured with Body Composition Analysis	12 months

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Rebecca Spirig, PHD, RN, Nursing Director, Head Office of Nursing and Allied Health Professionals

Publications and helpful links

General Publications

• Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: November 3, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: exercise; self-management; weight
• Other Study ID Numbers: KEK-ZK-Nr. 2011-0411