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Search / Trial NCT06464900

Effects of a Health Intervention on Fear of Hypoglycemia

Launched by YANGZHOU UNIVERSITY · Jun 13, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Behaviour Change Wheel Health Educational Intervention Fear Of Hypoglycaemic Impaired Awareness Of Hypoglycaemia Medical Support Self Management Attitude Type 2 Diabetes Mellitus

ClinConnect Summary

This clinical trial is looking at how a special health education program can help people with type 2 diabetes who are afraid of low blood sugar, known as hypoglycemia. The program is based on a theory called the Behaviour Change Wheel, which aims to change how people think and act regarding their health. The researchers want to see if this intervention can reduce fear and improve self-management for patients, making it easier for them to live with diabetes.

To participate, you need to be at least 18 years old, have been diagnosed with diabetes for at least a year, and feel a significant fear of low blood sugar, as measured by a specific scale. You should also be able to communicate well and use a smartphone for the study. However, if you have serious health issues or are currently involved in other similar studies, you won't be eligible. If you join, you can expect to learn more about managing your diabetes while receiving support from the program.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Comply with the 2020 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus;
  • Age ≥18 years;
  • Duration of diabetes mellitus ≥1 year;
  • FoH according to the elevated item endorsement criterion (E I criterion): ≥3 points on any item of the Hypoglycemic Fear-Worry Scale (HFS-WS);
  • Patients who have the ability to listen, read, write, walk, and cooperate to complete the study;
  • Patients who have a smart phone, and can skillfully use WeChat or telephone to communicate;
  • Voluntarily participate in this study and sign the informed consent form.
  • Exclusion Criteria:
  • Patients with comorbid acute complications or other serious diseases or disorders of consciousness, such as diabetic hypertonic state, tumors, coma, etc;
  • Patients with comorbid psychiatric diseases or taking psychotropic drugs;
  • Patients who have recently or are participating in other studies on similar topics.

About Yangzhou University

Yangzhou University is a prestigious educational and research institution located in Yangzhou, China, dedicated to advancing knowledge and innovation in various fields, including medicine and healthcare. As a clinical trial sponsor, Yangzhou University leverages its extensive academic resources and expertise to conduct high-quality research aimed at improving patient outcomes and contributing to the scientific community. The university fosters collaboration among multidisciplinary teams and emphasizes ethical practices and regulatory compliance in its clinical research endeavors, ensuring the integrity and reliability of its findings. Through its commitment to excellence, Yangzhou University strives to enhance the understanding of health-related issues and develop effective interventions that benefit society.

Locations

Yangzhou, Jiangsu, China

Patients applied

0 patients applied

Trial Officials

Zhao Yueqi, Master

Principal Investigator

Yangzhou University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported