Comparison of Two Health Education Modalities for Safe Ramadan Fasting in People With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Hypoglycemia
研究概览
简要总结
Adult Muslims are obliged to start fasting during the month of Ramadan. Fasting entails refraining from all food, drink, tablets and injections(vitamins & fluids) between sunrise and sunset; a period which varies by geographical location and season.
People with type 1 Diabetes are among those who are risky to fast this holy month in the Muslim faith and thus are exempted from fasting. Yet many patients fast in spite of medical advice and religious exemption and for those patients, healthcare professionals should provide the utmost care and continuous diabetes education.
Different diabetes education modalities exist like DSME (Diabetes self-management education with proven efficacy. One modality is the Diabetes Conversation Map which delivers diabetes education interactively through a series of maps that address different issues in diabetes management and includes a specially designed Ramadan map.
In this study, two modalities of Diabetes focused Ramadan education will be compared regarding aiding patients to fast Ramadan safely. One modality will be Diabetes conversation maps and the other the International Diabetes Federation Education modules.
详细描述
Adult Muslims are obliged to start fasting during the month of Ramadan. Fasting entails refraining from all food, drink, tablets and injections(vitamins & fluids) between sunrise and sunset; a period which varies by geographical location and season. Although exempt, many diabetics refuse to take this concession as they feel psychologically & spiritually inclined to fast along with other Muslims.
Fasting at Ramadan carries a very high risk for people with T1DM. This risk is particularly exacerbated in poorly controlled patients and those with limited access to medical care, hypoglycemic unawareness, unstable glycemic control, or recurrent hospitalizations.
Structured education interventions have been endorsed by the National Institute for Health and Clinical Excellence as important in empowering patients to improve their jour¬ney with diabetes. In a large observational study, patients who fasted during Ramadan without attending a structured education session had a fourfold increase in hypoglycae¬mic events, whereas those who attended an education pro¬gramme focusing on Ramadan had a significant decrease in hypoglycemic events.
Conversation Map aims to help people with diabetes experience a healthier Ramadan. The interactive Map covers a number of topics including understanding the risks and complications of fasting and the importance of creating a diabetes management plan during this time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are intending to fast .
- •Duration of diabetes is more than 5 years .
- •Insulin regimen is basal-bolus .
排除标准
- •Acute complications as major events of hypoglycemia or DKA during the last 3 months before Ramadan .
- •Pregnancy .
- •Previous stroke, MI, or unstable angina .
研究组 & 干预措施
IDF modules
Diabetes educations using IDF Arabic translated modules
干预措施: IDF modules (Behavioral)
Conversational Maps
Diabetes Educations using Ramadan fasting conversational maps (Arabic maps)
干预措施: Conversational Maps (Behavioral)
结局指标
主要结局
Hypoglycemia
时间窗: Detected through Self monitoring of blood glucose during 4 weeks of Ramadan fasting
Rate of attacks of hypoglycemia during Ramadan
次要结局
- Number of successful fasting days(During 4 weeks of Ramadan fasting)
- Insulin Dose Adjustment(During 4 weeks of Ramadan fasting)
- Body Weight Change(Measurement of body weight prior month of Ramadan and after the month of Ramadan)
研究者
Dr.Yara Eid
Professor of Internal Medicine-Endocrinology and Metabolism Unit , Ain-Shams University
Ain Shams University