Kidney Transplantation, Rental Transplantation
Conditions
Keywords
weight, self-management, exercise
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
Interventions
BEHAVIORALSelf-management program with monthly sessions
Patients participate in 9 sessions during the first 8th month after transplantaiton
BEHAVIORALUsual Care, containing one session
Session takes place within the first three months after transplantation
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline BMI at 8 months | 8th month | BMI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| difference of activity between control and intervention group at month 12 | month 12 | differences in steps measured with pedometer (Stepwatch) |
| change from baseline BMI at 12 months | 12th month | BMI |
| difference of self-reported adherence between control and intervention group at month 8 | month 8 | — |
| difference of activity between control and intervention group at month 8 | month 8 | differences in steps measured with pedometer (Stepwatch) |
| change from baseline LTM at 8 months | 8 months | LTM measured with Body Composition Analysis |
| change from baseline LTM at 12 months | 12 months | LTM measured with Body Composition Analysis |
| difference of self-reported adherence between control and intervention group at month 12 | month 12 | — |
Countries
Switzerland
Outcome results
None listed