跳至主要内容
临床试验/NCT05285969
NCT05285969招募中不适用

Motivational Interview for Cardiac Rehabilitation in Acute Myocardial Infarction: A Randomized Controlled Trial in the Primary Healthcare Area.

Consorci d'Atenció Primària de Salut de l'Eixample8 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
284
试验地点
8
主要终点
Physical functional capacity

研究概览

简要总结

Introduction: Secondary prevention after acute myocardial infarction may include cardiac rehabilitation and lifestyle changes. Cardiac rehabilitation has mainly taken place in hospitals without coordination with primary healthcare. Motivational interviews have been shown to be effective as a means for change in patients after acute myocardial infarction. The objective of this study is to evaluate the effectiveness of a cardiac rehabilitation program with motivational interviews in patients discharged from hospital after acute myocardial infarction.

Methods: Randomized clinical non-pharmacological trial. A minimum sample of 284 participants requiring cardiac rehabilitation after acute myocardial infarction in six primary healthcare centers. Participants will be randomized to cardiac rehabilitation with motivational interviews or normal standard of care. All secondary results will be evaluated at 1,3 and 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Age >18 years.
  • Hospital admission for acute coronary syndrome (diagnostic codes ICD-10: I20-I22).
  • Post unscheduled cardiac revascularization surgery (procedure code ICD-10: 021x).
  • Discharge to home with the area of the 7 PHCs.
  • Indication of RC indication.
  • Voluntary participation.

排除标准

  • Acute aortic disease,
  • Severe pulmonary hypertension.
  • Uncontrolled arrhythmias.
  • Decompensated Heart Failure or significant valvular or congenital heart disease.
  • Intervention in heart valves and/or interventricular septum.
  • Diseases that prevent exercise.
  • Osteoarticular disease that severely limits exercise.
  • Severe mental disorder.
  • Any severe psychiatric disorders.
  • Cognitive disability.
  • Verbal communication problems.
  • Participation in hospital Cardiac Rehabilitation.

结局指标

主要结局

Physical functional capacity

时间窗: 6th month

Improvement in aerobic capacity and resistance, measured by a physical effort test

次要结局

  • Effectiveness of secondary prevention(6th month)
  • Psychological status(6th month)
  • Perceived quality of life(3rd month)

研究者

发起方
Consorci d'Atenció Primària de Salut de l'Eixample
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luis Gonzalez de Paz

Researcher

Consorci d'Atenció Primària de Salut de l'Eixample

研究点 (8)

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