Health LiteracyNCT07194759
Health Literacy Levels of Patients Living With Type 2 Diabetes and Multi-disease and Their Families Using HLQTM
An observational study of Health Literacy, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
This study aims to identify health literacy strengths and needs among people living with type 2 diabetes and multi-disease and their family members. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Literacy
- How many people
- 4,611 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Type 2 diabetes patients and/or family members from four university hospitals in the Region of Southern Denmark. The patients will be invited to participate when they receive a questionnaire. This questionnaire is designed to provide participant information and consent prior to the sociodemographic questions and the health literacy questionnaire.
Who may be able to join
- living with Type 2 diabetes and multi-disease
- cognitively able to participate
- following an outpatient care program
Who cannot join
- patients in palliative care
- inability to read or speak Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient and Family Health Literacy - a Survey Among 5000 People
This study aims to identify health literacy strengths and needs among people living with type 2 diabetes and multi-disease and their family members.
Read the detailed description
Living with diabetes and multi-disease affects not only the individual but also the social network around the person, as self-management is dependent on the ability to change one's lifestyle and manage the consequences of disease. In other words, health literacy strengths and needs of the individual and family members are determinants of how people manage living with type 2 diabetes. Thus, we hypothesise that diabetes management is influenced by the patient's and family members' health literacy. Knowledge about their health literacy could further enhance a patient- and family-centred approach to diabetes treatment and care, improving self-management and promoting health.
- Conditions
- Health Literacy
- Keywords
- Diabetes Mellitus, Outpatients, Socioeconomic factors, Multiple chronic conditions, Family
- Medical subject headings
- Diabetes Mellitus, Multiple Chronic Conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Literacy Questionnaire (HLQ)
The Health Literacy Questionnaire (HLQ) is a 44-item validated questionnaire on health literacy. It consists of two parts, one part with 23 questions answered with a 4-point Likert Scale (strongly disagree = 1, disagree = 2, agree = 3, and strongly agree = 4). The second part has 21 questions answered with a 5-point Likert Scale (can't do/always difficult = 1, usually difficult = 2, sometimes difficult = 3, usually easy = 4, always easy = 5). The patient must select one of the scales for each of the 44 questions.
The answers are self-reported via REDCap, one time after the survey is distributed.
Measured: At Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Oct 2025
- Primary completion30 Oct 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 4,611 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frans Brandt Kristensen, Study chair, University Hospital of Southern Denmark, Hospital Sønderjylland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194759
- Sponsor's protocol ID
- SHS-MS-1-2025
- Status last verified
- May 2026
- First submitted
- 18 Sep 2025
- Last updated
- 19 May 2026
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Family Health Literacy - a Survey Among 5000 People
- ClinicalTrials.gov ID
- NCT07194759
- Acronym / sponsor ID
- SHS-MS-1-2025
- Conditions
- Health Literacy
- Keywords
- Diabetes Mellitus, Outpatients, Socioeconomic factors, Multiple chronic conditions, Family
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,611 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 26 Sep 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.
This study aims to identify health literacy strengths and needs among people living with type 2 diabetes and multi-disease and their family members.
Detailed description
Living with diabetes and multi-disease affects not only the individual but also the social network around the person, as self-management is dependent on the ability to change one's lifestyle and manage the consequences of disease. In other words, health literacy strengths and needs of the individual and family members are determinants of how people manage living with type 2 diabetes. Thus, we hypothesise that diabetes management is influenced by the patient's and family members' health literacy. Knowledge about their health literacy could further enhance a patient- and family-centred approach to diabetes treatment and care, improving self-management and promoting health.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes patients and/or family members from four university hospitals in the Region of Southern Denmark. The patients will be invited to participate when they receive a questionnaire. This questionnaire is designed to provide participant information and consent prior to the sociodemographic questions and the health literacy questionnaire.
Key inclusion criteria (3 listed)
- living with Type 2 diabetes and multi-disease
- cognitively able to participate
- following an outpatient care program
Key exclusion criteria (2 listed)
- patients in palliative care
- inability to read or speak Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health Literacy Questionnaire (HLQ)
Time frame: At Enrollment
The Health Literacy Questionnaire (HLQ) is a 44-item validated questionnaire on health literacy. It consists of two parts, one part with 23 questions answered with a 4-point Likert Scale (strongly disagree = 1, disagree = 2, agree = 3, and strongly agree = 4). The second part has 21 questions answered with a 5-point Likert Scale (can't do/always difficult = 1, usually difficult = 2, sometimes difficult = 3, usually easy = 4, always easy = 5). The patient must select one of the scales for each of the 44 questions. The answers are self-reported via REDCap, one time after the survey is distributed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- 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.
Frans Brandt Kristensen study chair
University Hospital of Southern Denmark, Hospital Sønderjylland
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 Health Literacy, run by University of Southern Denmark at 1 site in Denmark.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 19 May 2026. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Health Literacy Questionnaire (HLQ) (time frame: At Enrollment). 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 19 May 2026.