Clinical trial NCT04296955: Testing the Effect of KnowMAP (Knowledge Management for Renal Transplant Recipients). A Randomized Controlled Study
Official title: Testing the Effect of a New Health Communication Intervention for Renal Transplant Recipients (KnowMAP).
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Transplantation
Keywords: health literacy
motivational interview
adherence
organ transplantation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
First posted: 2020-03-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Health literacy (HL)
timeFrame: 24 months post transplantation
measure: Adherence to immunosuppressive medication
timeFrame: 24 months post transplantation
Secondary outcomes:
measure: Quality of life and cost-effectiveness estimates relevant to this clinical context
timeFrame: 24 months post transplantation
measure: Knowledge
timeFrame: 24 months post transplantation
measure: Occations of graft loss
timeFrame: 24 months post transplantation
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Andersen
role: PRINCIPAL_INVESTIGATOR
References: