Effects of a Health Intervention on Fear of Hypoglycemia

NCT06464900 | Not Yet Recruiting DMC

• 1 other identifier: YZUHL20230040
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health-Related Behavior; Health Education; Fear of Hypoglycemia; Impaired Awareness of Hypoglycemia; Self-Management; Type2 Diabetes Mellitus

Keywords

Behaviour Change Wheel; Health educational intervention; Fear of hypoglycaemic; Impaired awareness of hypoglycaemia; Medical support; Self-management attitude; Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Gold Rating

  Baseline, 4 and 12 weeks post-intervention

• The Patients Assessment Chronic Illness Care( PACIC)

  Baseline, 4 and 12 weeks post-intervention

• The self-management attitude scale for diabetes patients

  Baseline, 4 and 12 weeks post-intervention

Study Arms (2)

Routine Care

PLACEBO COMPARATOR

Implementation of routine diabetes health education.

Behavioral: Routine Care

Based on BCW Theory of Health Education

EXPERIMENTAL

A FoH intervention program based on BCW theory was implemented on top of the routine care.

Behavioral: Based on BCW Theory of Health Education

Interventions

Routine Care BEHAVIORAL

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.

Routine Care

Based on BCW Theory of Health Education BEHAVIORAL

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.

Based on BCW Theory of 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

MeSH Terms

Conditions

Health Behavior; Health Education; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhao Yueqi, Master

  Yangzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ma Hongxin, Master

CONTACT

+86 87974902; 007032@yzu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)