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临床试验/NCT05071495
NCT05071495已完成不适用

TeleDiet Study: A Randomized Controlled Study Investigating the Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease

Jessa Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月17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
60
试验地点
1
主要终点
MedDiet score (the Mediterranean diet score)

研究概览

简要总结

Digital cardiology is gaining power in the field of preventive cardiology recently, and several trials have already shown good results of dietary therapy with digital cardiology. However, there has been no reports that showed effect of dietary counseling through digital cardiology for secondary prevention of coronary artery disease.

TeleDiet study investigates the impact of dietary therapy with a smartphone application on the content of meals and metabolic parameters for patients with coronary artery disease.

研究设计

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

入排标准

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

入选标准

  • •Owning a smartphone and able to use it
  • •Written informed consent obtained
  • •Starting cardiac rehabilitation
  • •Coronary artery disease

排除标准

  • •Special diet due to other reasons (eg. renal diet, pancreatic insufficiency diet)
  • •Age <18 years old

研究组 & 干预措施

Intervention group

Experimental

干预措施: Smartphone application (Device)

Control group

No Intervention

结局指标

主要结局

MedDiet score (the Mediterranean diet score)

时间窗: Up to 3 months

This score has the extreme values of 0 (minimum) and 55 (maximum). Higher scores mean a better outcome.

次要结局

  • Values of self-efficacy (questionnaire of General Self-Efficacy Scale [GSE])(Up to 3 months)
  • Blood creatinine (Cr) test(Up to 3 months)
  • Blood glycated hemoglobin (HbA1c) test(Up to 3 months)
  • Values of quality of life (Health-related Quality of Life questionnaire [HeartQoL])(Up to 3 months)
  • Parameters in the ergospirometer test (anaerobic threshold [AT])(Up to 3 months)
  • Values of medication adherence (questionnaire of Identification of Medication Adherence Barriers [IMAB])(Up to 3 months)
  • Blood lipid tests (LDL-cholesterol [LDL-C], HDL-cholesterol [HDL-C], and triglyceride [TG])(Up to 3 months)
  • Parameters in the ergospirometer test (maximal oxygen consumption [VO2 max])(Up to 3 months)
  • Body weight (BW)(Up to 3 months)
  • Body mass index (BMI)(Up to 3 months)

研究者

发起方
Jessa Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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