Trials / Completed
CompletedNCT06197360
Effects of a Health Intervention on Fear of Hypoglycemia : a Pilot Study
Effects of a Health Education Intervention Based on the Behaviour Change Wheel on Fear of Hypoglycemia in Patients With Type 2 Diabetes Mellitus: a Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Yangzhou University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to construct a Fear of Hypoglycemia(FoH) intervention program for type 2 diabetic patients based on the Behaviour Change Wheel (BCW) theory and to investigate the feasibility, acceptability, and initial effects of the program.
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 4-week follow-up period, for a total of 8 weeks.
Conditions
- Type 2 Diabetes Mellitus
- Fear of Hypoglycemia
- Health Education
- Impaired Awareness of Hypoglycemia
- Self-Management
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Based on BCW Theory of Health Education | Questionnaire collection, face-to-face interview, and interpretation of the manual on the first day of admission; diabetes self-management teaching on the second day; and hypoglycemia-related lectures and hands-on teaching on the fourth day. Day 6 hypoglycemia fear case discussion. Face-to-face teaching and formulation of blood glucose management plan on the first day before discharge; WeChat push or telephone return visit one week and two weeks after discharge; WeChat push, telephone return visit and questionnaire collection three weeks after discharge. |
| BEHAVIORAL | General diabetes health education | Patients were provided with regular medication guidance, dietary guidance, exercise guidance and popularization of related diabetes knowledge; regular daily blood glucose testing and recording; and timely answers to patients' clinical problems and psychological support. |
Timeline
- Start date
- 2021-08-01
- Primary completion
- 2022-01-31
- Completion
- 2022-01-31
- First posted
- 2024-01-09
- Last updated
- 2025-02-10
- Results posted
- 2025-02-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06197360. Inclusion in this directory is not an endorsement.