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

NCT06197360 | Completed Results DMC

• 1 other identifier: YZUHL20210088
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Type 2 Diabetes Mellitus; Fear of hypoglycemia; Behavior Change Wheel theory; Impaired Awareness of Hypoglycemia; Self-Management

Outcome Measures

Primary Outcomes (2)

• Hypoglycemia Fear Behavioral

  Hypoglycemia Fear Survey - Behavior Scale consists of 19 entries and is scored on a 5-point Likert scale from 1 to 5, with total scores ranging from 15 (lowest) to 95 (highest), with the higher scores indicating that the patients' hypoglycemia fear-behavior is more pronounced, and the higher the level of fear of hypoglycemia.

  Baseline, immediately after the intervention and after the 4 weeks follow-up

• Hypoglycemia Fear Worry

  Hypoglycemic fear Survey - Worry Scale was used to evaluate the patients' hypoglycemic feelings in the past 6 months. There were 13 items in the scale, using 5-point Likert scale, with scores ranging from low to high 0-4, and the total score ranging from 0 (lowest) to 52 (highest). The higher the score, the higher the patient's fear of hypoglycemia.

  Baseline, immediately after the intervention and after the 4 weeks follow-up

Secondary Outcomes (3)

• Gold Rating

  Baseline, immediately after the intervention and after the 4 weeks follow-up

• The Patients Assessment Chronic Illness Care( PACIC)

  Baseline, immediately after the intervention and after the 4 weeks follow-up

• The Self-management Attitude Scale for Diabetes Patients

  Baseline, immediately after the intervention and after the 4 weeks follow-up

Study Arms (2)

General diabetes health education

PLACEBO COMPARATOR

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.

Behavioral: General diabetes health education

Based on BCW Theory of Health Education

EXPERIMENTAL

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

Behavioral: Based on BCW Theory of Health Education

Interventions

Based on BCW Theory of Health Education 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.

Based on BCW Theory of Health Education

General diabetes health education 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.

General diabetes health education

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

Yangzhou University

Yangzhou, Jiangsu, 225000, China

Location

Related Publications (2)

• 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.

  PMID: 35788767 RESULT

• 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 Dec;62(12):2071-2084. doi: 10.1007/s00592-025-02549-5. Epub 2025 Jun 23.

  PMID: 40548996 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Health Education

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Yueqi Zhao
• Organization: Yangzhou University

mz120221975@stu.yzu.edu.cn

13390676131

Study Officials

• Yueqi Zhao, Bachelor

  Yangzhou University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 9, 2024
• Study Start: August 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)