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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effects of a Health Education Intervention Based on the Behaviour Change Wheel on Fear of Hypoglycemia in Patients With Type 2 Diabetes Mellitus: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06197360
• Other study ID #: YZUHL20210088
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: January 2024
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
China	Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 pat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycemia fear behavioral	Hypoglycemia fear-behavior scale (HFS-BS) consists of 19 entries and is scored on a 5-point Likert scale from 1 to 5, with total scores ranging from 15 to 95, with the higher scores indicating that the patients' hypoglycemia fear-behavior is more pronounced, and the higher the level of fear of hypoglycemia. The higher the score, the more obvious the change in the patient's hypoglycemic fear behavior and the higher the degree of hypoglycemic fear.	Baseline, 4 and 8 weeks post-intervention
Primary	Hypoglycemia fear worry	Hypoglycemia fear survey-worry scale (HFS-WS) was used to assess the patients' feelings about hypoglycemia in the past six months. The scale has 13 entries, and adopts Likert's 5-point scale, with scores ranging from 0-4 from the lowest to the highest, and the total score ranging from 0 to 52, with the higher the score, the more fearful the patients are about hypoglycemia.	Baseline, 4 and 8 weeks post-intervention
Secondary	Gold Rating	The Gold Score, first proposed by Professor Gold of the United Kingdom in 1994, is currently the most commonly used method of assessing Impaired Awareness of Hypoglycemia (IAH), which reflects the patient's awareness of hypoglycemia side by side. The method consists of a single question, "Do you know when your hypoglycemia began?" Answers are given on a 7-point Likert scale ranging from "1" (always aware) to "7" (never aware), with a score of 1-3 being considered normal self-awareness of hypoglycemia, and a score of =4 indicating the presence of IAH.	Baseline, 4 and 8 weeks post-intervention
Secondary	The Patients Assessment Chronic Illness Care( PACIC)	Used to assess the quality of care provided by healthcare organizations in the U.S. chronic disease management model. The scale is completed by patients to report the extent to which they have received care in the past 6 months consistent with the chronic disease management model and can be used to reflect the level of medical support provided to patients by chronic disease management organizations such as hospitals.The PACIC scale is divided into 5 dimensions and 20 questions, each of which is based on the use of a 5-dimensional model of care. 7~11), problem solving/coherence (entries 12~15), and follow-up/collaboration (entries 16~20), and each entry is rated on a 5-point Likert scale, with scores ranging from 1~5 from the lowest to the highest, and with scores closer to 5, the higher the evaluation of chronic disease management, and the more support the patient receives from healthcare professionals.	Baseline, 4 and 8 weeks post-intervention
Secondary	The self-management attitude scale for diabetes patients	The subscale has 5 entries to evaluate patients' attitudes toward diabetes health education, diet control, exercise, medication compliance, and blood glucose monitoring. A Likert 5-point scale was used, assigning values of 1.0, 0.8, 0.6, 0.4, 0.2 in descending order, and the total mean scores of the 5 entries (range 0.2-1.0) represented the furosemide self-management attitude scores. A total mean score of <3.0 indicates a poor self-management attitude, 3.0 to 4.25 indicates a moderate self-management attitude, and >4.25 indicates a good self-management attitude.	Baseline, 4 and 8 weeks post-intervention