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

NCT ID: NCT02282124

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2018-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Self-management program with monthly sessions

Intervention Type: BEHAVIORAL

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

Control

Group Type: OTHER

Usual Care, containing one session

Intervention Type: BEHAVIORAL

Session takes place within the first three months after transplantation

Interventions

Self-management program with monthly sessions

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

Intervention Type: BEHAVIORAL

Usual Care, containing one session

Session takes place within the first three months after transplantation

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Spirig, PHD, RN

Role: PRINCIPAL_INVESTIGATOR

Nursing Director, Head Office of Nursing and Allied Health Professionals

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 36094829 (View on PubMed)

Other Identifiers

KEK-ZK-Nr. 2011-0411

Identifier Type: -

Identifier Source: org_study_id