Developing a Health Literacy Intervention for Immigrant Kidney Transplant Recipients (IMMIHEALTH)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Transplant Recipient (Kidney)
• Intervention / Treatment: Behavioral: Health literacy intervention

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0372
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Immigrant kidney transplant recipients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Two different groups of patients and two groups of nurses are included.; Before intervention development: Thirteen patients are interviewed three times following the kidney transplantation (during the first week, before transfer to the local hospital, about 4-6 weeks following kidney transplantation, and after 3 to 6 months). Nurses in three wards that follow these patients are interviews in five focus groups.; The intervention will then be developed in co-creation with nurses and patients. Optimizing intervention: - In the optimizing process, the interviews and focus group interviews are repeated to explore satisfaction and assess the need for change.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All outcomes are defined from qualitative data (Individual patient interviews and focus group interviews with nurses).	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.	November 2027

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Helse Sor-Ost (Helse Sør-Øst)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Health literacy intervention
• Other Study ID Numbers: 23/01097; 2023027 (Other Identifier: Helse Sor-Ost (Helse Sør-Øst))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No