Effectiveness of Diabetes Self-management Education on Diabetes Control in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Primary outcome measuring the mean change in HbA1c at 6 months
研究概览
简要总结
This is a randomized controlled trial assessing the effectiveness of a nurse led diabetes self management education(DSME) given over a 6 month period via mixed delivery strategy (in-person and via phone calls) on Hemoglobin A1c(HbA1c), fasting blood glucose(FBG), blood pressure, body weight and low density lipoprotein cholesterol(LDL-C).
The main question this research seeks to answer is
1. Does diabetes self-management education when combined with usual care improve glycaemic control when compared to usual care alone? Patients will be randomized into intervention and control groups. The intervention group will receive nurse led DSME using the American Association of diabetes educators 7 self care behaviour over a 6 month period. It will involve 3 monthly in-person sessions starting from the first day of recruitment as well as 2 weekly phone call sessions. This will be in addition to the usual care at the diabetes clinic.
The control group will receive usual diabetes care
详细描述
This a randomized controlled parallel design among 74 Type 2 diabetes mellitus(T2DM) patients recruited from the Komfo Anokye Teaching Hospital Diabetes clinic.
The primary outcome is the mean change in HbA1c at 6 months
The secondary outcomes include:
- The mean change in FBG at 3 months
- The mean change in blood pressure at 6 months
- The mean change in body weight at 6 months
- The mean change in LDL-C at 6 month
STUDY PROTOCOL USUAL CARE The current standard practice (the usual care) includes an outpatient specialist service with patients scheduled every 1 to 6 months, depending on their diabetes control and complications profile. The other services provided include dietician appointments, laboratory investigations, clinical examinations, group education on self-management practices, and medication refills.
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
- •Patients with T2DM who are at least 18 years old without any co-morbidities requiring immediate hospitalisation
- •HbA1c >7.9%
- •Have access to a personal mobile phone and able to answer calls.
- •Mentally stable, with no vision, verbal, or hearing impairments
- •Have access a glucometer.
- •Consents to the study
排除标准
- •Other forms of DM such as type 1 DM or gestational diabetes.
- •End-stage renal disease(eGFR<15ml/min)
- •History of stroke or other atherosclerotic cardiovascular diseases with impairment which makes the affected individual dependent on others for care giving and precludes self-care
研究组 & 干预措施
Group that received only usual care (Control )
The current standard practice (the usual care) includes an outpatient specialist service with patients scheduled every 1 to 6 months, depending on their diabetes control and complications profile. The other services provided include dietician appointments, laboratory investigations, clinical examinations, group education on self-management practices, and medication refills.
Usual care by a doctor entails a 10-15 min standard doctors' consultation where the recent HbA1c level and medication compliance are reviewed, and a brief informal patient-tailored diabetes education is offered. This enables the individual an opportunity to learn about self-management in a flexible and informal way. There is no structure to it and the information is offered according to what the patient requests to know as well as what the doctor thinks would be important for the patient to know, during that consultation.
Phone calls will be made to remind them of their clinic appointment for data collection.
Group that received DSME plus usual care (Intervention)
The intervention group will receive the usual consultation from their doctor and referral to a diabetes educator for individualized structured DSME training. A clinical sheet will be used while delivering the education to ensure that all core topics are covered. For this study, 2 diabetes educators will offer the individualized DSME sessions using the American Association of Diabetes Education (AADE) 7 self-care behaviour model. The participants are scheduled to attend a 1-hour individualised session at the hospital every 3 months as well as telephone consultations lasting up to 15 minutes every 2 weeks at the convenience of the participant to reinforce DSME for 6 months. The first session is arranged on the first day after consultation with the doctor. At the end of the sessions, the participants will receive a patient guide to diabetes booklet and graphic material illustrating several self-care activities such as foot care
干预措施: Intervention (Behavioral)
结局指标
主要结局
Primary outcome measuring the mean change in HbA1c at 6 months
时间窗: 6 months
Mean change in HbA1c
次要结局
- Secondary outcome measuring the mean change in fasting blood glucose at 3 months(3 months)
- Secondary outcome measuring the mean change in blood pressure at 6 months(6 months)
- Secondary outcome measuring the mean change in body weight at 6 months(6 months)
- Secondary outcome measuring the mean change in low density lipoprotein cholesterol at 6 months(6 months)
研究者
Kojo Awotwi Hutton-Mensah
Doctor
Komfo Anokye Teaching Hospital