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

Not Applicable

Completed

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

Interventions: Behavioral: Based on BCW Theory of Health Education
Behavioral: General diabetes health education

Registration Number: NCT06197360

Lead Sponsor: Yangzhou University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Based on BCW Theory of Health Education	Based on BCW Theory of Health Education	A FOH intervention program based on BCW theory was implemented on top of the control group.
General diabetes health education	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.

Primary Outcome Measures

Name	Time	Method
Hypoglycemia Fear Behavioral	Baseline, immediately after the intervention and after the 4 weeks follow-up	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.
Hypoglycemia Fear Worry	Baseline, immediately after the intervention and after the 4 weeks follow-up	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.

Secondary Outcome Measures

Name	Time	Method
The Patients Assessment Chronic Illness Care( PACIC)	Baseline, immediately after the intervention and after the 4 weeks follow-up	The Patient Assessment Chronic Care Scale was developed with support from the Johnson Foundation to assess the quality of care provided by healthcare organizations. Patients use this scale to report their perceived level of medical support. The PACIC scale consists of five dimensions and 20 questions, each of which is rated on a 5-point Likert scale (1 to 5), with higher scores (close to 5) indicating greater support from healthcare professionals. The score for each dimension is calculated based on the average score of the items it contains, and the total table score is calculated based on the average score of all 20 items, with a minimum score of 1 and a maximum score of 5. Total scale score ≤1.75 is classified as low level of medical support; An overall average score of 1.75 to 3.5 indicates moderate medical support; Total mean score ≥3.5 was classified as high medical support.
Gold Rating	Baseline, immediately after the intervention and after the 4 weeks follow-up	Gold Score was first proposed by Professor Gold in the UK in 1994. It is the most commonly used assessment method for Impaired Awareness of Hypoglycemia, which reflects patients' awareness of hypoglycemia at the same time. The only question with this approach is, "Do you know when your low blood sugar started?" Likert scores 7 on a scale of "1" (always aware) to "7" (never aware), with an overall score from 1 (lowest) to 7 (highest). An overall score of 1-3 is considered normal hypoglycemic self-awareness, and a score of ≥4 indicates the presence of IAH.
The Self-management Attitude Scale for Diabetes Patients	Baseline, immediately after the intervention and after the 4 weeks follow-up	The Self-Management Attitude Scale for Diabetic Patients is a sub-scale of the Self-Management Knowledge, Attitude and Behavior Assessment Scale for Diabetic Patients compiled by the Chinese Center for Prevention and Control of Chronic Noncommunicable Diseases (CPCNCD). The scale included five items that assessed patients' attitudes toward diabetes health education, diet control, physical activity, medication adherence, and blood glucose monitoring. The 5-point Likert scale was used, with 1 indicating "very important" and 5 indicating "very unimportant", and the scores were divided into 0.2, 0.4, 0.6, 0.8 and 1.0 in order from low to high. The total score of the five items is the total self-management attitude score (range 1-5), and a score below 3.0 indicates a poor self-management attitude. A score of 3.0 to 4.25 indicates an average self-management attitude, while a score of 4.25 or above indicates a good self-management attitude.