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临床试验/NCT03506230
NCT03506230Unknown不适用

The Effect of Financial Incentives on Improvement of Glycemic Control in Diabetic Patients From Low Socioeconomic Background

Clalit Health Services1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
180
试验地点
1
主要终点
Differences in HbA1c after six months

研究概览

简要总结

Patients with uncontrolled diabetes [glycated hemoglobin (Hba1c)>8.5%] from low socioeconomic status neighborhoods in Jerusalem will be recruited. They will be randomly assigned to an intervention group and a control group. The intervention group will be offered a bonus to buy their medications, 100 Israeli Shekels (ILS) (30$) each month for 3 months, if they reduce their HBA1c by 0.7% or if their HbA1c level reaches 7.5%. After 6 months they will be eligible for another bonus for one month if they improve their HbA1c by 0.3% from the previous test. The control group will buy medications as usual. All participants will be contacted by phone and will be encouraged to contact their doctor, to perform blood tests and to maintain a healthy lifestyle.

详细描述

The study will be performed in primary care clinics in a big Health Funds in Jerusalem and the area (Clalit Health Services). Guidance will be given to the professional staff in the clinics and the pharmacists in the pharmacies of the Health Care Fund. Candidates will be identified from lists of diabetic patients and will be invited to the clinic or will be contacted upon arrival to the clinic. Candidates that will agree to participate in the study will sign an informed consent and answer a small survey.

Candidates that do not have a recent HbA1c result (from the last month) will be referred to perform a blood test. Only patients with an updated result of 8.5% or higher, will be included in the study. The participants will receive explanations from the research staff or the medical professionals at the clinic. General recommendations for diabetes care will be provided orally, and a written summary will be given. Contact details with the research staff will be provided as well.

All participants will be contacted by phone to inform them of their group membership within three days of the recruitment, or 3 days after receiving the result of the blood test. The information will be delivered by a member of the research team that will not know the participants. The result will be sent by mail as well.

The incentives group participants will be told they will receive a bonus to buy their medications at the designated pharmacies. After three months, if they reduce their HBA1c by 0.7% compared to the previous test, or if their HbA1c level is reduced to 7.5% or below, they will get a bonus of up to 100 ILS (30$) every month, for the next three months depending on the total amount of their purchased medicine that month. Six months after entering the trial they will be entitled to a bonus for one additional month if they have reduced their HbA1c level by 0.3% compared to the last test. The bonus can be used to pay for chronic prescription drugs for diabetes, hypertension (HTN) or hyperlipidemia those who are included in the Israeli "health basket," or not included.

The standard treatment group will buy medications as usual. All participants will be encouraged to get their treatment and prescriptions from their physician, and to take their medication regularly. They will receive recommendations for a healthy lifestyle with low-sugar diet and physical activity, be encouraged to perform routine blood and urine tests and have an eye examination once a year. They will receive by mail a tracking page for documentation of hypoglycemia events. They will be asked to document events of symptomatic low blood sugar (55mg/dl or less) and to indicate whether they needed help to recover from hypoglycemia. They will be told a research assistant will contact them during the follow- up period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of type 2 diabetes for at least 6 months
  • Diabetes for a maximum of ten years
  • Updated HbA1c level of between 8.5 and 11% from the last month
  • Agreement to participate and sign an informed consent

排除标准

  • Pregnancy
  • Insulin therapy
  • Psychiatric disorder from the first or second line according to the Diagnostic and Statistical Manual of mental disorders (DSM)
  • Active oncology disease [excluding squamous cell carcinoma (SCC) and basal cell carcinoma (BCC)
  • Planed bariatric surgery for the next 6 months
  • Cardiac hospitalization in the previous year
  • A severe hypoglycemia event three months prior to allocation

研究组 & 干预措施

Incentives group

Experimental

a bonus to buy their medications if they improve their HbA1c

干预措施: Incentives (Behavioral)

Standard group

No Intervention

Will buy their medications as usual

结局指标

主要结局

Differences in HbA1c after six months

时间窗: Six months

Differences between the groups in the change in HbA1c between the test at the entrance to the study and the test six months later

次要结局

  • Differences in HbA1c after three months(3 months)
  • Differences in the proportion of participants who improved their HbA1c by 1% or more(Six months)
  • Whether or not HbA1c test was performed at 3 months(Two months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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