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临床试验/NCT01522001
NCT01522001已完成4 期

Shared Care Rehabilitation After Acute Coronary Syndrome

University of Aarhus6 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
212
试验地点
6
主要终点
Participation in cardiac rehabilitation

研究概览

简要总结

Cardiac rehabilitation is an individual adapted multidisciplinary intervention for people suffering from Heart Disease. It involves;

  • Dietary counseling,
  • Exercise training,
  • Psychosocial support,
  • Physician
  • smoking cessation
  • Patient education

The purpose is quick and complete recovery and to reduce the chance of recurrence.

In Denmark people admitted with Acute Cardiac Disease is referred to a course of hospital based cardiac rehabilitation at discharge.

The Danish Municipal Reform of 2007 changed the responsibility of rehabilitation from the Regions, who runs the hospitals, to the municipalities.

Shared care is in this setting that elements of treatment are completed different places in Health Care.

The aim of this study is:

  • to establish a shared care model for Cardiac rehabilitation following admission with Acute Coronary Syndrome and
  • to compare this model to the existing hospital based cardiac rehabilitation after admission with Acute Coronary Syndrome.

Primary outcome is participation in cardiac rehabilitation.

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
None

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

  • Admission with Acute Coronary Syndrome
  • Resident in district of Department of Cardiology, Aarhus University Hospital, Silkeborg or Viborg Hospital, part of the "Hospitalsenheden Midt" Viborg, Silkeborg, Skive, Hammel.
  • Accept both models of cardiac rehabilitation
  • written informed consent

排除标准

  • Resident outside the district of Department of Cardiology, Aarhus University Hospital, Viborg Hospital or Silkeborg Hospital, part of "Hospitalsenheden Midt" (Viborg, Silkeborg, Skive, Hammel).
  • Age 80 years or older
  • Heart Failure (Ejection Fraction less than 40%)
  • Severe Comorbidity
  • Resuscitated and need of support from ergotherapist after discharge.

结局指标

主要结局

Participation in cardiac rehabilitation

时间窗: 4 months

Participation in cardiac rehabilitation is evaluated for each element. Participation is defined as at least 50% for each element. * Smoking cessation * Dietary counseling * Exercise training * Physician * Patient education * Psychosocial support Full participation is in 6 of 6 elements if smoker or 5/5 if non-smoker. Partial full participation is in 5/6 if smoker or 4/5 if non-smoker.

次要结局

  • Change of BMI and / or abdominal circumference(4 and 12 months)
  • Blood Cholesterol values (Total, LDL, HDL)(4 and 12 months)
  • Exercise Capacity(4 and 12 months)
  • Lifestyle changes(4 and 12 months)
  • 24-hour Ambulatory Blood Pressure(4 og 12 months)
  • Depression score(4 and 12 months)
  • Difference in Health economic costs(4 and 12 months)
  • Fasting Blood glucose(4 and 12 months)
  • Compliance to pharmaceutical treatment(4 and 12 months)
  • Readmission(4 and 12 months)
  • Change in Health Related Quality of Living(4 and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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