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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hypoglycemia Fear Behavioral
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Hypoglycemia Fear Behavioral
时间窗: Baseline, immediately after the intervention and after the 4 weeks follow-up
Hypoglycemia Fear Survey - Behavior Scale consists of 19 entries and is scored on a 5-point Likert scale from 1 to 5, with total scores ranging from 15 (lowest) to 95 (highest), with the higher scores indicating that the patients' hypoglycemia fear-behavior is more pronounced, and the higher the level of fear of hypoglycemia.
Hypoglycemia Fear Worry
时间窗: Baseline, immediately after the intervention and after the 4 weeks follow-up
Hypoglycemic fear Survey - Worry Scale was used to evaluate the patients' hypoglycemic feelings in the past 6 months. There were 13 items in the scale, using 5-point Likert scale, with scores ranging from low to high 0-4, and the total score ranging from 0 (lowest) to 52 (highest). The higher the score, the higher the patient's fear of hypoglycemia.
次要结局
- The Patients Assessment Chronic Illness Care( PACIC)(Baseline, immediately after the intervention and after the 4 weeks follow-up)
- Gold Rating(Baseline, immediately after the intervention and after the 4 weeks follow-up)
- The Self-management Attitude Scale for Diabetes Patients(Baseline, immediately after the intervention and after the 4 weeks follow-up)
研究者
Zhao Yueqi
Principal Investigator
Yangzhou University