Testing the Effect of KnowMAP (Knowledge Management for Renal Transplant Recipients). A Randomized Controlled Study

Study Overview
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Brief Summary
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A randomized controlled study (RCT) aiming to test the effect of a new health literacy intervention for renal transplant recipients, KnowMAP (knowledge management for renal transplant recipients).

Detailed Description
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Every year about 250-300 kidney transplantations are performed at Oslo University Hospital in Norway. Considerable improvements have recently emerged within kidney transplantation in relation to survival and quality of life. However, after transplantation, adherence to immunosuppressive drug therapy and other medical advices is crucial for staying healthy, keeping the graft, and retain good quality of life. In case of graft loss the patient has to return to dialysis, representing reduced functioning, fatigue and negative impact on quality of life. Dialysis also leads to higher costs for the society and in many cases a need for re-transplantation. A key challenge to adherence is the ability to gain access to, understand and use health information, defined as health literacy by the WHO. For renal transplant recipients preparedness for handling information and going through transplantation is essential. Hence, supporting the patients becoming reflective and health literate knowledge users is crucial. Through a RCT this project aims to test the effect of a new health communication intervention, KnowMAP (knowledge management for renal transplant recipients), as compared with standard care in patients undergoing renal transplantation. KnowMap is a novel intervention designed by clinicians and researchers at Oslo University Hospital (OUS), University of Oslo (UiO) and University of Stavanger (UiS). The intervention is targeting knowledge management skills of patients by using motivational interview (MI) techniques. It represents 4 sessions of individual patient counselling starting the first week after the transplantation.

Official Title
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Testing the Effect of a New Health Communication Intervention for Renal Transplant Recipients (KnowMAP).

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Other: Motivational interview as a new health communication intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney transplanted patients > 18 years included within few days after kidney transplantation at Oslo University Hospital Able to speak and understand Norwegian Exclusion Criteria: Not able to speak or understand Norwegian well enough to be able to fill out forms or have a conversation in Norwegian. Kidney transplanted patient <18 years

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
Interventional Model Description: Interventional study model: Parallel assignment. 2- arm un-blinded RCT design. The arms are: The intervention: 4 individual patient counseling sessions using adapted motivational interviewing techniques in addition to usual care. Usual care: patients undergo standard patient education program for renal transplant recipients at OUS.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health communication intervention<br>Motivational interview as a new health communication intervention (one arm) | Other: Motivational interview as a new health communication intervention<br>* Same as intervention name<br>|
| No Intervention: Standard care<br>Standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health literacy (HL) | HL measured by the HLQ (Health Literacy Questionnaire): The HLQ includes 44 items over nine independent scales, each representing a different element of the overall HL construct. Each scale includes 4-6 items. The first five scales comprise items asking the respondents to indicate level of agreement [ranging from strongly disagree to strongly agree (range 1-4)]. The remaining scales (6-9) have domains of self-reported capability (range 1-5: 'cannot do' to 'very easy'). The questionnaire has no total score, as that could potentially mask individual needs in specific HL domains. The HLQ appears robust for its intended purpose of assessing HL in a range of settings and has shown excellent reliability. | 24 months post transplantation | 
| Adherence to immunosuppressive medication | The instrument BAASIS (The BAsel Adherence to immunoSuppressIve medication Scale) a self reporting adherence questionnaire measuring patients' taking, skipping, timing (>2 hrs from prescribed time) and dose reduction of drugs. The recall period is limited to four weeks. The BAASIS comprises four questions with a 6-point scale for responses ranging from never (0) to every day (5) | 24 months post transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and cost-effectiveness estimates relevant to this clinical context | using EQ-5D-5L, introduced by EuroQoL in 2009. It is a two pages, standardized generic questionnaire. | 24 months post transplantation | 
| Knowledge | Using a Norwegian developed questionnaire: The Transplantation Knowledge Questionnaire | 24 months post transplantation | 
| Occations of graft loss | Registred in the Norwegian Renal Registry (NNR) | 24 months post transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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organ transplantation, health literacy, motivational interview, adherence