Transplant Recipient (Kidney)IMMIHEALTHNCT06860139
Developing a Health Literacy Intervention for Immigrant Kidney Transplant Recipients
An observational study of Transplant Recipient (Kidney), run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Recipient (Kidney)
- What is being tested?
- Health literacy intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2024to 28 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Immigrant kidney transplant recipients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- 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).
- What experiences, competence and competence needs does the nurses that engage in patient education to immigrant KTRs post-transplant have?
- Will a tailored intervention increase HL, medication adherence, and outcomes after patient education in immigrant KTXs and organizational HL and cultural competence in nurses?
Read more
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)
- Being tested
- Health literacy intervention
- Keywords
- Health literacy intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health literacy interventionBehavioural
The intervention will be developed in co-creation with patients and nurses in the clinic, based on their needs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Health literacy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: November 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Mar 2024
- Primary completionDec 2027 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant Recipient (Kidney)Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Sor-Ost
- Responsible party
- Principal investigator, Kari Gire Dahl, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860139
- Sponsor's protocol ID
- 23/01097
- Other IDs
- 2023027
- Acronym
- IMMIHEALTH
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Health Literacy Intervention for Immigrant Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06860139
- Acronym / sponsor ID
- IMMIHEALTH / 23/01097
- Conditions
- Transplant Recipient (Kidney)
- Keywords
- Health literacy intervention
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Helse Sor-Ost
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- What experiences, competence and competence needs does the nurses that engage in patient education to immigrant KTRs post-transplant have?
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two different groups of patients and two groups of nurses are included. | – | Behavioral: Health literacy interventionBefore 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Immigrant kidney transplant recipients
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health literacy interventionThe intervention will be developed in co-creation with patients and nurses in the clinic, based on their needs. | Behavioural | Two different groups of patients and two groups of nurses are included. |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant Recipient (Kidney), run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All outcomes are defined from qualitative data (Individual patient interviews and focus group interviews with nurses). (time frame: November 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.