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

University of Zurich (UZH)

Status: Completed

Conditions: Kidney Transplantation; Rental Transplantation

Treatments: Behavioral: Usual Care, containing one session; Behavioral: Self-management program with monthly sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT02282124

KEK-ZK-Nr. 2011-0411

Details and patient eligibility

About

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.

Full 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

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Self-management program with monthly sessions

Control

Other group

Treatment:

Behavioral: Usual Care, containing one session