ClinicalTrials.gg
CompletedNCT07194759Updated May 19, 2026

Health Literacy Levels of Patients Living With Type 2 Diabetes and Multi-disease and Their Families Using HLQTM

An observational study in Health Literacy, sponsored by University of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by University of Southern Denmark · Observational

Study type
Observational
Model
Family-based
Time perspective
Cross-sectional
Enrollment
4,611
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Health Literacy

Keywords

  • Diabetes Mellitus
  • Outpatients
  • Socioeconomic factors
  • Multiple chronic conditions
  • Family
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's enrollment of 4,611 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Southern Denmark is the lead sponsor of 336 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • living with Type 2 diabetes and multi-disease
  • cognitively able to participate
  • following an outpatient care program

Exclusion criteria

Exclusion Criteria:

  • patients in palliative care
  • inability to read or speak Danish
05

Study design

Observational model
Family-based
Time perspective
Cross-sectional
Enrollment
4,611 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At Enrollment

07

Study locations

1 site
  • Sygehus Sønderjylland
    Aabenraa, Southern Denmark 6200, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2025 to primary completion in Oct 2025, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2025
First posted
Sep 26, 2025
StartActual
Oct 1, 2025
Primary completionActual
Oct 30, 2025
CompletionActual
Apr 1, 2026
Last update
May 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07194759
Responsible party
Sponsor
First posted
Sep 26, 2025
Start date
Oct 1, 2025
Primary completion
Oct 30, 2025
Completion
Apr 1, 2026
Last update
May 19, 2026

Study contacts

Frans Brandt Kristensen
study chair · University Hospital of Southern Denmark, Hospital Sønderjylland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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