跳至主要内容
临床试验/NCT05948241
NCT05948241进行中(未招募)不适用

Online Psychological Support Group for Patients With Heart Failure and Depression in Promoting Self-care: a Randomized Clinical Trial

Instituto de Cardiologia do Rio Grande do Sul2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2022年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
132
试验地点
2
主要终点
Changes in European Heart Failure Self-Care Behavior Scale's Scores

研究概览

简要总结

Heart failure is a chronic disease, being the second cause of death in Brazil. Currently, it is estimated that 6.4 million Brazilians suffer from this disease. The higher number of rehospitalization, lower survival of these individuals. There are recommendations from Societies of Cardiology for the inclusion of effective self-care for patients with chronic HF, intend greater control of symptoms, greater adherence to treatment and, consequently, decrease of rehospitalization. One of the pillars of self-care's education for chronic patients recommended by the Health Ministry is the management of the patient's emotional aspects. These have been undertreated in most studies. The prevalence of depression among patients with HF is high and ranges from 41% to 72%, and the assessment with the BDI-II, which is the gold standard used, is 67%. Patients with HF and depression have greater difficulty in adhering to treatment and poor maintenance of self-care. Also, they present 4 times more risk of rehospitalization/mortality. Faced with this problem, this project was designed, proposing an online psychological support group for patients with heart failure and depression, primarily aimed at improving self-care, adherence and secondarily at reducing the rates of depression and readmission.

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
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

  • Patients diagnosed with heart failure
  • Age between 18 and 79 years B)
  • After hospital discharge
  • Depression (BDI-II score above 14 points)
  • Acceptance of the Term of Consent;

排除标准

  • Patients with dementia
  • Communication barriers
  • Octogenarians
  • People unable to access the internet for the intervention
  • Who declined to participate;

结局指标

主要结局

Changes in European Heart Failure Self-Care Behavior Scale's Scores

时间窗: From baseline to 4 months

Changes in Self-care scale scores

次要结局

  • Changes in Morisky and Green points(From baseline to 4 moths)
  • The average hospitalization's days in 1 year follow up(From baseline to 1 year follow up)
  • Changes in Beck Depression Inventory Scores (BDI-II)(From baseline to 4 months)

研究者

发起方
Instituto de Cardiologia do Rio Grande do Sul
申办方类型
Other
责任方
Sponsor

研究点 (2)

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