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临床试验/NCT05096637
NCT05096637Unknown不适用

PreventiPlaque - Digital Secondary Prevention in Cardiovascular Disease to Improve Therapy Adherence

University Hospital, Essen0 个研究点目标入组 240 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
240
主要终点
Change in cardiovascular risk profile

研究概览

简要总结

Although advances in knowledge of the prevention, diagnosis and treatment of atherothrombosis are encouraging, cardiovascular diseases (CVD), with acute and chronic ischemic heart disease in particular, remain a major cause of disability and premature death throughout the world.

Cardiac rehabilitation (CR) and secondary prevention are coordinated multidimensional evidence-based strategies that aim to assist patients with acute and chronic ischemic heart disease return to an active and satisfying life and to prevent the recurrence of further cardiac events. Since CR is time limited after an acute event, secondary prevention proposes a continuum where care is provided for the rest of a person's life according to the existence of cardiovascular risk factors. Secondary prophylaxis is fundamental for the recovery of the patient, but in most cases, it is only insufficiently implemented.

To ensure adequate resources for the delivery of health care and to further improve the level of care, care-delivery models need to be changed in a way that patients themselves become more involved in their own care. Mobile health (mHealth) is a rapidly growing health delivery methodology with the potential to impact on health care research, health care delivery and health outcomes.

Therefore, the aim of the study is to determine the impact of plaque visualization using a digital intervention on treatment adherence to improve the cardiovascular risk profile. Participants will be randomized into two groups: intervention group and control group. Participants of the control group receive the best medical care according to current guideline recommendations without access to the app. Participants of the intervention group receive the best medical care according to current guideline recommendations with full access to the Smartphone application at time of study begin until the completion of the follow-up period of 12 months. The access to the app includes access to relevant findings including ultrasound images of the carotid artery, lipid profile, blood pressure values, and weight.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ultrasound evidence of atherosclerotic plaque in one or both carotid arteries
  • Own a smartphone and know how to use apps
  • presumed life expectancy of more than one year
  • willing to comply with the protocol and provide written informed consent

排除标准

  • congestive heart failure with NYHA (New York Heart Association classification) III-IV symptoms
  • severe valve disease
  • no german knowledge
  • unwillingness to user the app and/or undergo diagnostic procedures

结局指标

主要结局

Change in cardiovascular risk profile

时间窗: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months

Measured via SCORE2 (Systematic Coronary Risk Evaluation) risk calculator

次要结局

  • Change in cigarette dependency(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Change in body weight(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Reported physical activity(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Change in blood pressure(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Change in LifeSimple7-Score(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Change in LDL-cholesterol(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Change in reported medication adherence(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)
  • Satisfaction with outpatient care(baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months)

研究者

发起方
University Hospital, Essen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia Lortz

PD Dr. med.

University Hospital, Essen

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