NCT06464900

Effects of a Health Intervention on Fear of Hypoglycemia

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Yangzhou University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-06-18
• Last updated: 2024-07-09

Locations

1 site across 1 country: China