Clinical trial NCT06860139: Developing a Health Literacy Intervention for Immigrant Kidney Transplant Recipients
Official title: Developing a Health Literacy Intervention for Immigrant Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Transplant Recipient (Kidney)
Keywords: Health literacy intervention
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost (Helse Sør-Øst)
First posted: 2025-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Immigrant kidney transplant recipients

Brief summary: The goal of this complex interventions study is to improve health literacy (HL), medication adherence and patient education outcomes in immigrant kidney transplant recipients (KTRs). Furthermore, we aim to strengthen HL sensitivity and cultural competence in nurses providing patient education. The main questions we aims to answer are:

1. What are immigrant KTRs HL strengths and needs, medication adherence and outcomes after patient education in three important transitions following kidney transplantation: the first postoperative phase (3-7 days post-transplantation), preparing for transfer to local hospital (6-8 weeks post-transplantation), and adapting to the home context (3-6 months post-transplantation).
2. What experiences, competence and competence needs does the nurses that engage in patient education to immigrant KTRs post-transplant have?
3. Will a tailored intervention increase HL, medication adherence, and outcomes after patient education in immigrant KTXs and organizational HL and cultural competence in nurses?

Qualitative methods will be used to develop and optimize the intervention.

* Patients will be invited to three individual interviews in the three postoperative phases.
* Nurses in three wards (surgery, medical and outpatient ward) are asked to participants in focus group interviews.
* The interviews will be used to define needs and build the intervention. Ideas to the intervention will be discussed in workshops with nurses, the project group and user participants.
* Parts of the intervention will be tested in the clinic followed by 'think aloud interviews' where both the nurse and the patient are asked to speak freely about their experiences using the intervention.
* The intervention will be evaluated by repeating the interviews with patient and focus group interviews with nurses.
* The intervention will be feasibility tested.


Eligibility criteria: Inclusion Criteria:

* Immigrant kidney transplant recipients in Norway. Immigrant defined as a person that has immigrated to Norway and that has two parents and two grandparents born in another country than Norway.

Exclusion Criteria:

* Patients from high-income countries, as defined by the Global Burden of Disease (GBD) framework. The GBD study is the largest and most comprehensive effort to quantify health loss across places and over time (https://www.healthdata.org/research-analysis/gbd). High income countries are western Europe, North America, Australia, New Zealand, Japan, Brunei, Republic of Korea, and Singapore (https://ghdx.healthdata.org/countries). National and international studies report that people with background from low-income countries have lower sociodemographic scores and lower health literacy levels. Therefore, the study will focus on these patients. The majority of immigrant kidney transplant recipients in Norway are from low-income countries.

Primary outcomes:
measure: All outcomes are defined from qualitative data (Individual patient interviews and focus group interviews with nurses).
timeFrame: November 2027
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: