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Completed

NCT Number: NCT07194759

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

This study aims to identify health literacy strengths and needs among people living with type 2 diabetes and multi-disease and their family members.

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Key information

Conditions

Health Literacy Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Multiple Chronic Conditions Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sygehus Sønderjylland

Aabenraa, Southern Denmark, 6200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

Patient and Family Health Literacy - a Survey Among 5000 People

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 26, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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