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临床试验/NCT01772446
NCT01772446已完成不适用

Effectiveness of Sending Sms Text Messages to Mobile Phone Patients to Remind Upcoming Appointments and Improve the Control of Diabetic Patients in Primary Care

Basque Health Service1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2013年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
117
试验地点
1
主要终点
Compare the percentage of patients in the intervention group versus the control group who get a HbA1c below 7%

研究概览

简要总结

Introduction: The Spanish Society of Family and Community Medicine, started the Program of Preventive Activities and Health Promotion, which generates periodic recommendations of preventive methods based on scientific evidence. In the last update it has become evident the need of modifications to adapt the program to modern times and focuses on improving accessibility and offering more flexible responses to users of the program. In this sense, the mobile phone technology could be useful, specifically the messaging service to remind patients their appointments and increase attendance rates. Main objective Compare the percentage of patients in the intervention group compared with the control group who achieved a figure of HbA1c <7% in 2013.Design: single blind Randomized Clinical Trial. Study population: Patients with diabetes with or without hypertension or lipid metabolism disorder, over 18 years, belonging to the Public Health System of Basque Country (primary care) meeting the inclusion / exclusion criteria. Sample size: 238 patients (119 per arm) to detect a difference of 16% in the percentage of patients with HbA1c lower than 7% between groups: Short Messages Standard (SMS) group: Mobile messages reminding the next review of Papps. Control group: Routine clinical practice. Statistical analysis: The relationship between the intervention received and the main variable (compliance with preventive activities at 12 months) were analyzed using a logistic regression model.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
35 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Type 2 diabetic patients with or without hypertension or lipid metabolism disorder,
  • •Aged between 35 and 74 years old with or without hypertension or lipid metabolism disorder,
  • •Mobile phone holder,
  • •Able to read messages via mobile phone.

排除标准

  • •Pregnant women,
  • •Patients whose next date for HbA1c control is less than 2 months
  • •Patients with HbA1c <7%

研究组 & 干预措施

CONTROL GROUP

No Intervention

ROUTINE CLINICAL PRACTICE

SMS MESSAGING

Experimental

SMS MESSAGES TO MOBILE PHONE TO REMEMBER THE NEXT CONTROL OF GLYCATED HEMOGLOBIN

干预措施: SMS MESSAGING (Behavioral)

结局指标

主要结局

Compare the percentage of patients in the intervention group versus the control group who get a HbA1c below 7%

时间窗: 12 months

次要结局

  • Evaluate whether the intervention is more effective (reducing HbA1c below 7%) in patients with predictive risk index <1.5, or in patients with predictive risk index> 1.5.(at 12 month)
  • Compare the mean change in HbA1c values between SMS group patients and control patients(6 and 12 months)
  • Evaluate the percentage of patients who are controlled. We consider controlled patient when HbA1C <7%, BP <140/80 and cardiovascular risk <20% measured by the scale of Heart Register of Gerona (REGICOR)(6 and 12 months)
  • Compare the percentage of patients in the intervention group compared with the control group that meet the following preventive recommendations(12 months)
  • In patients with predictive risk index <1.5, to compare the incidence of diabetic complications in each group(12 months)
  • To identify factors associated with better compliance of preventive activities in both groups(12 months)

研究者

发起方
Basque Health Service
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Raquel Cobos Campos

Epidemiologist

Basque Health Service

研究点 (1)

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