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临床试验/NCT05872919
NCT05872919已完成不适用

Telehealth and Challenges in Statin Adherence in Patients With Diabetes: A Randomized Controlled Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年7月15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
入组人数
90
试验地点
1
主要终点
Adherence rate

研究概览

简要总结

To evaluate the effect of telehealth through short messaging services (SMSs) on adherence to statins in patients with diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

MA will provide randomization AD will assess participant at baseline and follow-up EH will deliver the intervention.

入排标准

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

入选标准

  • •Adult (≥18 years)
  • •Both sexes
  • •Type 1 and 2 diabetes
  • •Had a prescription of lipid lowering medication with a minimum duration of two weeks
  • •Have an active contact phone number that can receive text messages
  • •Able to read SMS text messages (patient, or family member)

排除标准

  • •Communication impairment
  • •Taking any psychotropic medications
  • •Familial hypercholesterolemia
  • •Already established coronary heart disease
  • •not on lipid lowering medication

研究组 & 干预措施

Control group

No Intervention

will not receive the intervention

Study group

Experimental

will receive the intervention

干预措施: SMS reminder massages about adherence (Other)

结局指标

主要结局

Adherence rate

时间窗: 6 and 12 weeks

Adherence rate was measured by: 1\. Pill counting (PC) Pill count (PC) Is an objective mesearrment, calculated by the sum of days covered by lipid-lowering medication divided by the number of days in that period. Investigators calculated the index date for adherence on the day of recruitment for each patient. Patients were considered to have good adherence to lipid-lowering medication if their estimated PC was ≥80%, Equation : Sum of days covered by lipid-lowering medication / number of days in that period × 100. Percentage ≧ 80% means a good medication adherence Percentage \< 80% means a poor medication adherence

次要结局

  • Lipid profile(at 12 week)
  • Mortality(at 12 weeks)
  • Acute cardiovascular events (CVE)(at 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amna A. Desouky, MD

Associate Professor

Assiut University

研究点 (1)

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