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

NCT07194759 | Enrolling By Invitation

• 1 other identifier: SHS-MS-1-2025
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health Literacy

Keywords

Diabetes Mellitus; Outpatients; Socioeconomic factors; Multiple chronic conditions; Family

Outcome Measures

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.

  At Enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Sygehus Sønderjylland

Aabenraa, Southern Denmark, 6200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frans Brandt Kristensen

  University Hospital of Southern Denmark, Hospital Sønderjylland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 26, 2025
• Study Start: October 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)