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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intensity of the intervention follows a defined algorithm during the first eight months after renal transplantation. Behaviours are classified in three groups:
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. |
|
| Control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-management program with monthly sessions | Behavioral | Patients participate in 9 sessions during the first 8th month after transplantaiton |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline BMI at 8 months | BMI | 8th month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Spirig, PHD, RN | Nursing Director, Head Office of Nursing and Allied Health Professionals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36094829 | Derived | 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. |
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| Usual Care, containing one session | Behavioral | Session takes place within the first three months after transplantation |
|
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 |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000073278 | Self-Management |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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