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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2025-10-31

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).

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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.

Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional study model: Parallel assignment. 2- arm un-blinded RCT design. The arms are:

1. The intervention: 4 individual patient counseling sessions using adapted motivational interviewing techniques in addition to usual care.
2. Usual care: patients undergo standard patient education program for renal transplant recipients at OUS.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Block randomization

Study Groups

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Health communication intervention

Motivational interview as a new health communication intervention (one arm)

Group Type EXPERIMENTAL

Motivational interview as a new health communication intervention

Intervention Type OTHER

Same as intervention name

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Motivational interview as a new health communication intervention

Same as intervention name

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No