"Reinforcement of Adherence to Prescription Recommendations in Diabetic Patients Using Short Message Service (SMS)- A Pilot Study"
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Behavioural changes resulting in diet, better adherence to treatment.
研究概览
简要总结
Type 2 diabetes is a chronic metabolic disorder requiring lifestyle modification and medicines, adherence to which has to be practised on a daily basis.
Motivation of patients to adhere to treatment is difficult in clinical practice. It is well documented that majority of patients do not reach the glycaemic targets even in the centres of excellence. Regular short service messages (SMS) through cell phones could have a positive effect on behaviour and adherence to life style changes and compliance to drugs. It may be practical and feasible to use information technology as an effective and simple tool for motivating patients to adhere to the prescribed treatment regimen.
In diabetic patients, frequent reminders regarding the need for adherence to LSM and drugs by the medical professionals will improve the compliance.
详细描述
In diabetic patients, frequent reminders by the medical professionals on the need for adherence to Life Style Modification (LSM) and drugs will improve the compliance. SMS may be an effective and cheap tool of communication. Improved compliance is likely to result in better glycaemic control.
Out of total number of 200, consecutive randomization of 100 patients each to SMS or usual care arms will be done. Patients in the SMS group will get SMS once in 3 days as a reminder. Patients will be reviewed at 3, 6, 9 and 12 months from the date of randomization
Fasting and 2hr postprandial glucose and HbA1c will be tested during each visit.
At baseline and at the end of the study, lipids, and renal function test will also be done. A validated questionnaire will be used to assess physical activity, diet habits, adherence to drug prescriptions and frequency of monitoring of blood glucose. . Body weight, blood pressure, biochemical variables, scores for diet and physical activity and compliance to drugs, will be compared using students 't' test or chi-square test as relevant.
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
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 30-65 yrs of age at the time of entry and have type 2 diabetes for a minimum period of 5 years.
- •HbA1C ranging 8.0-10.0%
- •Patients either receiving OHA and / or insulin
排除标准
- •Type 1 diabetes
- •Patients with history of blindness, decreased vision
- •Serious vascular complications :
研究组 & 干预措施
1 is experimental with SMS
Arm 1 is experimental with SMS intervention
干预措施: Pre-coded messages (Behavioral)
2 is (active comparator) standard care
Arm 2 is the usual care arm (standard care)
干预措施: Diabetes Treatment (Drug)
结局指标
主要结局
Behavioural changes resulting in diet, better adherence to treatment.
时间窗: At intervals of three months for one year
次要结局
- Reduction in HbA1c, other glycemic measures and improvement in blood lipid parameters(Annual)