Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life

Study Overview
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Brief Summary
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For patients with end-stage kidney disease, transplantation is the treatment of choice, offering improved quality of life by restored metabolism and freedom from dialysis. However, demands regarding the acquirement of knowledge in life post transplantation are high. In order to reduce rejection episodes, graft loss and the negative consequences of life-long immunosuppressive medication, it is essential for kidney recipients to possess knowledge about important aspects regarding immunosuppressive medication, graft surveillance and the benefit of specific lifestyle behavior. Consequently, patient education is required for this patient group. This randomized controlled trial is investigating the effect of a structured patient education program on kidney recipients' knowledge, coping and quality of life

Official Title
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Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life. A Randomized Controlled Trial.

Conditions
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Renal Recipients

Intervention / Treatment
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* Behavioral: Patient education program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being over 18 recently had a kidney transplant able to speak, understand and read Norwegian mentally able to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient education program<br> | Behavioral: Patient education program<br>* All patients receive standard care. Experimental group receive a structured patient education program based in self-care theory and pedagogical theory, build upon the the principles of the Pro-Self education program. The intervention program consist of five weekly one-to-one sessions with a transplant nurse, lasting about 40-60 minutes, starting during the first week after discharge and lasting until 7 weeks post transplantation. Education content consists of two levels: general knowledge level and individual knowledge. Each session has a specific program. In addition, academic detailing is used to describe patient's knowledge levels and for tailoring the education to individual needs.<br>|
| No Intervention: Standard care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney recipients'knowledge level | Knowledge level is measured by a self-administrated knowledge questionnaire consisting of 19 items addressing knowledge in relation to three areas: medication, rejection and lifestyle. Each item is rated using a 5 points scale, anchored on the left with the wording totally disagree(1), rather disagree (2) either agree or disagree (3), quite agree (4) and to the left with totally agree(5). Patients are asked to put a ring around a number to indicate their level of agreement with each item. | 7-8 weeks post kidney transplantation | 
| Kidney recipients'knowledge level | Knowledge level is measured by a self-administrated knowledge questionnaire consisting of 19 items addressing knowledge in relation to three areas: medication, rejection and lifestyle. Each item is rated using a 5 points scale, anchored on the left with the wording totally disagree(1), rather disagree (2) either agree or disagree (3), quite agree (4) and to the left with totally agree(5). Patients are asked to put a ring around a number to indicate their level of agreement with each item. | 6 months post kidney transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney recipients' coping | Coping is measured by the following self-administrated questionnaires: The Generalized Self-efficacy Scale, The Long-term Medication Behavior Self-efficacy Scale and The Moriscy Compliance scale. In addition, the number of missing observations in the patients' transplant diaries is counted.(The transplant diary contains patients own daily observations of graft function and signs of rejection). Number of missing observations are counted from observation start and during a period of 7-8 weeks. The percent of missed observations of total possible observations are estimated. | 7-8 weeks post kidney transplantation | 
| Kidney recipients' coping | Coping is measured by the following self-administrated questionnaires: The Generalized Self-efficacy Scale, The Long-term Medication Behavior Self-efficacy Scale and The Moriscy Compliance scale. | 6 months post kidney transplantation | 
| Kidney recipients' quality of life | Quality of life is measured by the following self -adminstred questionnaires: The acute version of the Short Form Health Survey (SF-12) and the disease-spesific quality of life questionnaire: The Kidney Transplant Questionnaire | 7-8 weeks post kidney transplantation | 
| Kidney recipients' quality of life | Quality of life is measured by the following self -adminstred questionnaires: The acute version of the Short Form Health Survey (SF-12) and the disease-spesific quality of life questionnaire: The Kidney Transplant Questionnaire | 6 months post kidney transplantation |