Effects of a Health Intervention on Fear of Hypoglycemia
NCT Number: NCT06464900
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Health-Related Behavior|Health Education|Fear of Hypoglycemia|Impaired Awareness of Hypoglycemia|Self-Management|Type2 Diabetes Mellitus
Interventions: BEHAVIORAL: Routine Care|BEHAVIORAL: Based on BCW Theory of Health Education
Sponsor: Yangzhou University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07
Completion Date: 2025-01
Locations: Yangzhou University, Yangzhou, Jiangsu, 225000, China

Summary:
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.

Primary Outcome Measures: Hypoglycemia fear survey, Fear of hypoglycemia (FoH) was assessed using the Hypoglycemic Fear Survey Scale (HFS), which consists of two subscales, the Hypoglycemic Fear Survey- Behavioral Scale (HFS-BS) and the Hypoglycemic Fear Survey-Worry Scale (HFS-WS). (1) The HFS-BS scale has 19 entries, using a 5-point Likert scale, with scores ranging from 1 \~ 5 in descending order, and a total score of 15 \~ 95, with higher scores indicating more obvious hypoglycemic fearful behaviors in patients. (2) HFS-WS has 13 entries, which were scored using a 5-point Likert scale, with scores ranging from 0 to 4 from low to high, and a total score of 0 \~ 52. The higher the score, the higher the degree of fear of hypoglycemia in patients. The two subscale scores were added together, and the higher the total score, the more severe the fear of hypoglycemia., Baseline, 4 and 12 weeks post-intervention
Secondary Outcome Measures: 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 12 weeks post-intervention|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 12 weeks post-intervention|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 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 12 weeks post-intervention