Clinical trial NCT02282124: Effectiveness of an APN-led Self-management Program in Patients in the First Year After Renal Transplantation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Rental Transplantation
Keywords: weight
self-management
exercise
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: change from baseline BMI at 8 months
timeFrame: 8th month
Secondary outcomes:
measure: difference of activity between control and intervention group at month 8
timeFrame: month 8
measure: difference of activity between control and intervention group at month 12
timeFrame: month 12
measure: change from baseline BMI at 12 months
timeFrame: 12th month
measure: difference of self-reported adherence between control and intervention group at month 8
timeFrame: month 8
measure: difference of self-reported adherence between control and intervention group at month 12
timeFrame: month 12
measure: change from baseline LTM at 8 months
timeFrame: 8 months
measure: change from baseline LTM at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Nursing Director, Head Office of Nursing and Allied Health Professionals
name: Rebecca Spirig, PHD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.