Developing a Health Literacy Intervention for Immigrant Kidney Transplant Recipients

NCT ID: NCT06860139

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2029-02-28

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.

Conditions

Transplant Recipient (Kidney)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Health literacy intervention

Intervention Type: BEHAVIORAL

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

Interventions

Health literacy intervention

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Sor-Ost (Helse Sør-Øst)

UNKNOWN

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kari Gire Dahl

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oslo University Hospital

Oslo, Oslo County, Norway

Countries

Norway

Other Identifiers

2023027

Identifier Type: OTHER

Identifier Source: secondary_id

23/01097

Identifier Type: -

Identifier Source: org_study_id