Status:
COMPLETED
Effects of a Health Intervention on Fear of Hypoglycemia : a Pilot Study
Lead Sponsor:
Yangzhou University
Conditions:
Type 2 Diabetes Mellitus
Fear of Hypoglycemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study was to construct a Fear of Hypoglycemia(FoH) intervention program for type 2 diabetic patients based on the Behaviour Change Wheel (BCW) theory and to investigate the feasibi...
Detailed Description
In this study, eligible participants were randomized in a 1:1 ratio into an intervention group (health education based on BCW theory given on top of regular diabetes health education) and a control gr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06197360
Start Date
August 1 2021
End Date
January 31 2022
Last Update
February 10 2025
Active Locations (1)
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1
Yangzhou University
Yangzhou, Jiangsu, China, 225000