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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Hypoglycemia fear survey
研究概览
简要总结
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.
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 8-week follow-up period, for a total of 12 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
- Single (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 survey
时间窗: Baseline, 4 and 12 weeks post-intervention
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.
次要结局
- Gold Rating(Baseline, 4 and 12 weeks post-intervention)
- The self-management attitude scale for diabetes patients(Baseline, 4 and 12 weeks post-intervention)
- The Patients Assessment Chronic Illness Care( PACIC)(Baseline, 4 and 12 weeks post-intervention)
研究者
Zhao Yueqi
Principal Investigator
Yangzhou University