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Active, Not Recruiting

NCT Number: NCT06860139

Developing a Health Literacy Intervention for Immigrant Kidney Transplant Recipients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0372, Norway

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Health literacy intervention

Behavioral

The intervention will be developed in co-creation with patients and nurses in the clinic, based on their needs.

Primary outcomes

  1. All outcomes are defined from qualitative data (Individual patient interviews and focus group interviews with nurses).

    Time frame: November 2027

    Patients experiences from patient education, health literacy (strengths, challenges, expectations and needs), information about medication adherence and transplant knowledge will be collected using qualitative interviews. The interview guide is developed using the conversational health literacy tool (CHAT), that involve questions about health literacy. The tool is flexible and adaptable to the transplant context and will also involve questions regarding medication adherence and transplant knowledge.

    Nurses experience from giving patient education will be collected through focus group interviews. The interview guide involves the following four main themes: experiences giving patient education to immigrant kidney transplant recipient, giving patient education using an interpreter, competence and competence needs and documenting patient education with immigrant patients.

    Quantitative measures are not used.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Helse Sor-Ost

Registry information

Acronym: IMMIHEALTH

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Mar 5, 2025
Registry last updated
Mar 5, 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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