Effects of a Health Intervention on Fear of Hypoglycemia : a Randomized Controlled Study

Type2 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 Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06464900
• Other study ID #: YZUHL20230040
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Yangzhou University
• Contact: Ma Hongxin, Master
• Phone: +86 87974902
• Email: 007032[@]yzu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 8-week follow-up period, for a total of 12 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• 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
• Type2 Diabetes Mellitus

Intervention

Behavioral:
• Routine Care
Provide patients with regular medication guidance, dietary guidance, exercise guidance and knowledge about diabetes mellitus and hypoglycaemia; test and record blood glucose regularly every day; answer patients' clinical questions and provide psychological support in a timely manner.
• Based on BCW Theory of Health Education
BCW theory was applied to analyse behaviour and develop interventions in terms of capability, motivation and opportunity. Capability: Intensive daily management of diabetes through intervention functions (education, training, persuasion, modelling) to change attitudes and habits, understand the negative consequences of fear of hypoglycaemia, improve hypoglycaemia awareness and self-regulation skills. Opportunity: Through the intervention function (education, training, realization) to improve the awareness of hypoglycemia awareness, timely detection of hypoglycemia. In the event of a hypoglycaemic event patients know how to deal with it. Motivation: Through intervention functions (environmental reconstruction, realisation) that take full account of external factors and their own opportunities. Glucose management through microsoft platforms, on-site teaching and coaching by specialist nurses to create opportunities for patients who can change excessive/avoidant behaviours.

Locations

Country	Name	City	State
China	Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycemia fear survey	Fear of Hypoglycemia (FoH) were evaluated using the Hypoglycaemia Fear Survey (HFS), including the Hypoglycaemia fear survey-behaviour scale (HFS-BS) and the Hypoglycaemia fear survey-worry scale (HFS-WS). (1) The HFS-BS, which consists of 19 entries, using a Likert 5-point scale, with scores ranging from 1 to 5 from the lowest to the highest, The total score ranging from 15 to 95, with higher scores indicating that the patient's hypoglycaemia fear behaviours were more pronounced. (2) The HFS-WS, which consisted of 13 entries, and was rated on a Likert scale of 5 points, with a score of 0~4 from the lowest to the highest, and a total score of 0 to 52, with the higher the score, the higher the degree of the fear of hypoglycaemia in the patient.	Baseline, 4 and 12 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 12 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 12 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; - Page3of5 - 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 12 weeks post-intervention