Impact:Improving Adherence and Commitment to Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Diabetes Control as Expressed by the Change in HbA1c %
研究概览
简要总结
In the IMPACT project, the investigators want to improve adherence and commitment to treatment.
详细描述
In this study the investigators use 3 interventions in diabetic patients and one control, to find what is the best intervention to improve adherence to healthy life style and medication therapy. the 3 intervention as followed: 1) meetings and follow-up by the medical team; 2) meetings and follow-up by trained peers; 3) system for sending SMS, operate according to algorithm.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •Oral medication or insulin
- •According to the HbA1c test result, 0.5% above the target for the patient's personal balance and below the 10%, the most recent, but in any event not more than six months prior to the study patient recruitment
- •Patients speak and read Hebrew
- •owners of a mobile phone that can receive text messages (SMS messages/ notifications) and have the ability to use the application (relevant for the SMS notification arm)
排除标准
- •Active malignant disease
- •creatinine levels above 2
- •Getting medicines that elevate sugar levels as steroids, chemotherapy
- •Three months after Myocardial Infraction (myocardial ischemia), surgical intervention, cardiac event
- •Patients who are planning major surgery
- •Patients who are planning a residential zone change
- •Patients with acute complications of diabetes under active treatment (such as limb amputation)
- •Patients diagnosed with unbalanced mental disorders
- •patients who can not sign the form on their own "informed consent"
- •patients suffering from dementia
- •Patients who are not mobile (dependent on the therapist)
研究组 & 干预措施
medical team
personal meetings and follow-up of un-balanced diabetic patients by trained medical team (nurse and doctor), which designed to promote adherence to healthy life style and medical therapy.
干预措施: medical team (Behavioral)
peers group
group meetings and follow-up of un-balanced diabetic patients by trained peers (peers: balanced diabetic patients),which designed to promote adherence to healthy life style and medical therapy.
干预措施: peers group (Behavioral)
SMS notifications
un-balanced diabetic patients receiving daily SMS with content,which designed to promote adherence to healthy life style and medical therapy.
干预措施: SMS notification (Behavioral)
control
un-balanced diabetic patients will get the basic and regular treatment for diabetic patients according to Clalit Health Services. In addition, the patients will have the same check-ups like all the patients in the experimental arms.
结局指标
主要结局
Diabetes Control as Expressed by the Change in HbA1c %
时间窗: 0, 6, 12 & 18 months
Participants will undergo HbA1c periodical lab test, the data needed for the trial will be extracted from electronic medical record
次要结局
未报告次要终点