A Randomised Parallel-group Multi-centre Study to Evaluate the Effect of Structured Diabetes Self-management Education Versus Standard of Care on Glycaemic Control, Self-efficacy and Quality of Life in Adults in Two Low Resource Settings in Accra Subsequent to COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Change in mean glaciated heamoglobin (HbA1c) at three months
研究概览
简要总结
We aim to study the effect of a structured diabetes education program (DESMOND) on diabetes outcomes in a ghanaian population over 3 months
详细描述
Protocol summary Background: Health systems in low-income countries are overburdened. Corona virus disease-19 (COVID-19) is a pandemic caused by a novel corona virus, Severe acute respiratory syndrome-corona virus 2 (SARS-CoV2) while diabetes is a long-standing global epidemic. COVID-19 further stresses the already overburdened health systems and Public Health measures to contain COVID-19 have severely disrupted health service delivery, particularly routine care. Delivery of diabetes specific education has traditionally been tied to routine visits and delivered in-person. COVID-19 will likely continue to influence service delivery beyond the pandemic, thus alternative ways of delivering diabetes specific education is needed.
Diabetes self-management education is vital to providing diabetes care. It equips patients with critical knowledge and skills for self-care. Recent edicts to stay home in relation to COVID-19 have further heightened the importance of self-care. Appropriate self-management behaviours are associated with lower levels of diabetes related distress, better quality of life and diabetes outcomes overall. Maintaining tight glycaemic control, early in diabetes is associated with fewer microvascular complications and vice versa. Complications of diabetes are prevalent in low resource settings in Africa; partly because of inadequate knowledge on self-care. Diabetes self-management education which is structured and tailor-made for low resource settings may modify self-care behaviors and result in improved self-care, glycaemic control and quality of life.
Aim:
To compare structured diabetes self-management education with standard of care among adults living with type 2 diabetes
Methods:
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 (Care Provider)
盲法说明
Persons delivering the intervention are not involved in patient care
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
- •Inclusion criteria
- •Self-identified as Ghanaian
- •Ability to speak either English and or Twi
- •be aged > 18 years
- •be receiving treatment at the study site as an out-patient
- •be willing to accept the 6-hour DSME intervention
- •be physically able to participate
- •be primarily responsible for their own care
- •be ambulant at time of recruitment
- •be able to participate in activities in a group setting
- •have permanent residence in Greater Accra
排除标准
- •known to have cognitive defects
- •known to have type I diabetes
- •known to be pregnant at the time of recruitment or planning to become pregnant during the study or have given birth less than three months prior to recruitment
- •known to have sickle cell disease
- •Participating in another intervention study at time of recruitment
- •known to have chronic medical complications of diabetes (cardiac, renal, neuropathy, hepatic) or systemic illness at the time of recruitment
- •recruitment of a member of the patients household for this study
结局指标
主要结局
Change in mean glaciated heamoglobin (HbA1c) at three months
时间窗: 3 months
change in glycaemic control
次要结局
- Change in mean fasting plasma glucose (FPG) at three months(3 months)
- Change in mean fasting blood glucose (FBG) at three months(3 months)
- Change in mean blood pressure (BP) at three months(3 months)
- Change in waist circumference (WC) at three months(3 months)
- Change in neck circumference (NC) at three months(3 months)
- Change in body weight (BW) at three months(3 months)
- Change in problem areas in diabetes (PAID-5) scores(3 months)
- Change in mean summary of diabetes self-care activities (SDSCA) score at three months(3 months)
- Change in mean WHO quality of life (WHOQoL BREF) score at three months(3 months)