Effects of a Health Intervention on Fear of Hypoglycemia

Yangzhou University

Status: Not yet enrolling

Conditions: Impaired Awareness of Hypoglycemia; Fear of Hypoglycemia; Type2 Diabetes Mellitus; Self-Management; Health Education; Health-Related Behavior

Treatments: Behavioral: Based on BCW Theory of Health Education; Behavioral: Routine Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06464900

YZUHL20230040

Details and patient eligibility

About

To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.

Full 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 group (regular diabetes health education), with a 4-week intervention period and a 8-week follow-up period, for a total of 12 weeks.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups, including a placebo group

Routine Care

Placebo Comparator group

Description:

Implementation of routine diabetes health education.

Treatment:

Behavioral: Routine Care

Based on BCW Theory of Health Education

Experimental group

Description:

A FoH intervention program based on BCW theory was implemented on top of the routine care.

Treatment:

Behavioral: Based on BCW Theory of Health Education