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NCT Number: NCT04296955

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational interview as a new health communication intervention

Other

Same as intervention name

Primary outcomes

  1. Health literacy (HL)

    Time frame: 24 months post transplantation

    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.

  2. Adherence to immunosuppressive medication

    Time frame: 24 months post transplantation

    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)

Secondary outcomes

  1. Quality of life and cost-effectiveness estimates relevant to this clinical context

    Time frame: 24 months post transplantation

    using EQ-5D-5L, introduced by EuroQoL in 2009. It is a two pages, standardized generic questionnaire.

  2. Knowledge

    Time frame: 24 months post transplantation

    Using a Norwegian developed questionnaire: "The Transplantation Knowledge Questionnaire"

  3. Occations of graft loss

    Time frame: 24 months post transplantation

    Registred in the Norwegian Renal Registry (NNR)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Helse Sor-Ost

Registry information

Official study title

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

Acronym: KnowMAP

Important dates

Study start
2020
Primary completion
2021
Study completion
2025
First posted
Mar 5, 2020
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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