Effects of a Health Intervention on Fear of Hypoglycemia : a Pilot Study

NCT ID: NCT06197360

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-01-31

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 feasibility, acceptability, and initial effects of the program.

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

Conditions

Type 2 Diabetes Mellitus; Fear of Hypoglycemia; Health Education; Impaired Awareness of Hypoglycemia; Self-Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

General diabetes health education

Patients were provided with regular medication guidance, dietary guidance, exercise guidance and popularization of related diabetes knowledge; regular daily blood glucose testing and recording; and timely answers to patients' clinical problems and psychological support.

Group Type: PLACEBO_COMPARATOR

General diabetes health education

Intervention Type: BEHAVIORAL

Patients were provided with regular medication guidance, dietary guidance, exercise guidance and popularization of related diabetes knowledge; regular daily blood glucose testing and recording; and timely answers to patients' clinical problems and psychological support.

Based on BCW Theory of Health Education

A FOH intervention program based on BCW theory was implemented on top of the control group.

Group Type: EXPERIMENTAL

Based on BCW Theory of Health Education

Intervention Type: BEHAVIORAL

Questionnaire collection, face-to-face interview, and interpretation of the manual on the first day of admission; diabetes self-management teaching on the second day; and hypoglycemia-related lectures and hands-on teaching on the fourth day. Day 6 hypoglycemia fear case discussion. Face-to-face teaching and formulation of blood glucose management plan on the first day before discharge; WeChat push or telephone return visit one week and two weeks after discharge; WeChat push, telephone return visit and questionnaire collection three weeks after discharge.

Interventions

Based on BCW Theory of Health Education

Questionnaire collection, face-to-face interview, and interpretation of the manual on the first day of admission; diabetes self-management teaching on the second day; and hypoglycemia-related lectures and hands-on teaching on the fourth day. Day 6 hypoglycemia fear case discussion. Face-to-face teaching and formulation of blood glucose management plan on the first day before discharge; WeChat push or telephone return visit one week and two weeks after discharge; WeChat push, telephone return visit and questionnaire collection three weeks after discharge.

Intervention Type: BEHAVIORAL

General diabetes health education

Patients were provided with regular medication guidance, dietary guidance, exercise guidance and popularization of related diabetes knowledge; regular daily blood glucose testing and recording; and timely answers to patients' clinical problems and psychological support.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Zhao Yueqi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yueqi Zhao, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Yangzhou University

Locations

Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

References

Zhong W, Lin L, Gong X, Chen Z, Chen Y, Yan S, Zhou Y, Zhang X, Hu H, Tong L, Cheng C, Gu Q, Chen Y, Yu X, Huang Y, Yuan C, Lou M; MISSION investigators. Evaluation of a multicomponent intervention to shorten thrombolytic door-to-needle time in stroke patients in China (MISSION): A cluster-randomized controlled trial. PLoS Med. 2022 Jul 5;19(7):e1004034. doi: 10.1371/journal.pmed.1004034. eCollection 2022 Jul.

Reference Type: RESULT

PMID: 35788767 (View on PubMed)

Zhao Y, Zhang L, Pang J, Qiu J, He Y, Xu Z, Han M, Liu L, Wan X, Wang J, Zhang Y. Effects of a health education intervention based on the behavior change wheel on fear of hypoglycemia behavior in type 2 diabetes mellitus patients: a randomized controlled pilot trial. Acta Diabetol. 2025 Jun 23. doi: 10.1007/s00592-025-02549-5. Online ahead of print.

Reference Type: DERIVED

PMID: 40548996 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

YZUHL20210088

Identifier Type: -

Identifier Source: org_study_id