Effects of a Health Intervention on Fear of Hypoglycemia

NCT ID: NCT06464900

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-01-31

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.

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Routine Care

Implementation of routine diabetes health education.

Group Type: PLACEBO_COMPARATOR

Routine Care

Intervention Type: 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.

Based on BCW Theory of Health Education

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

Group Type: EXPERIMENTAL

Based on BCW Theory of Health Education

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Zhao Yueqi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhao Yueqi, Master

Role: PRINCIPAL_INVESTIGATOR

Yangzhou University

Locations

Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Central Contacts

Ma Hongxin, Master

Role: CONTACT

007032@yzu.edu.cn

+86 87974902

Facility Contacts

Hongxin Ma, Master

Role: primary

Other Identifiers

YZUHL20230040

Identifier Type: -

Identifier Source: org_study_id