Construction and Preliminary Verification of interventionImpact of an IMB Theory-based Health Education Intervention on Hypoglycemic Coping in Patients With Type 2 Diabetes: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Yating Liu
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The hypoglycemic coping style
研究概览
简要总结
From August 2023 to January 2024, 100 patients with type 2 diabetes who met the inclusion and exclusion criteria were selected from the endocrinology department of The purpose of this study was to construct a hypoglycemia coping intervention program for type 2 diabetic patients based on the IMB 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 IMB 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who meet the 2018 ADA medical standards for Diabetes diagnosis and treatment, are diagnosed with T2DM and use insulin or sulfonylurea drugs;
- •Duration of diabetes mellitus ≥1 year
- •Age ≥18 years old;
- •A history of hypoglycemia in the past 6 months;
- •Type 2 diabetes patients with hypoglycemia coping style questionnaire inclination, avoidance, compromise;
- •Good communication and language skills;
- •Have a smartphone and can use it;
- •Voluntary participation in this study.
排除标准
- •Patients with type 1 diabetes;
- •Patients with type 2 diabetes combined with serious complications;
- •Patients who have recently or are participating in other similar studies.
结局指标
主要结局
The hypoglycemic coping style
时间窗: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
The scale consists of 16 entries in 3 dimensions, which in this study are confrontation (entries 1, 6, 8, 11, 12, 15), avoidance (entries 2, 5, 7, 10, 13, 16), and submission (entries 3, 4, 9, 14), and each of the entries is rated on a Likert's 5 scale ranging from 0-4, with higher scores on the dimensions indicating a greater tendency toward this type of coping, and the scale's total Cronbach's alpha coefficient was 0.821.
次要结局
- Hypoglycemia fear worry(Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention)
- Level of diabetes knowledge(Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention)
- hypoglycemic fear behavioral(Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention)
- Level of health information access behavior(Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention)
- Level of health beliefs(Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention)