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临床试验/NCT03606304
NCT03606304撤回不适用

Using Problem-solving Intervention (PST-HF) to Improve Depressive Symptoms and Self- Care Ability Among Recently Hospitalized Older Patients With Heart Failure: A Feasibility Study

University of Rochester0 个研究点开始时间: 2019年5月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Problem-solving skills

研究概览

简要总结

The purpose of this study is to examine the feasibility of providing a problem-solving therapy-based intervention to improve both depressive symptoms and heart failure self-care specifically after hospital discharge. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of adverse outcomes, such as hospital readmission.

详细描述

Depressive symptoms and impaired self-care respectively occur in up to 58% and 80% of older hospitalized patients with heart failure, and each doubles the risk of rehospitalization. These two conditions are closely intertwined with shared core behaviors/experiences, i.e., hopelessness/negative expectation, loss of motivation, impaired problem-solving skills, and social isolation/poor social support. As such, integrated interventions that explicitly address both depressive symptoms and impaired HF self-care are more efficacious than interventions that focus on depressive symptoms or HF self-care alone. In separate studies, problem-solving therapy (PST) has been effective to improve depressive symptoms and self-care for heart disease in older adults, including those with mild cognitive impairment. Though promising, there is no evidence regarding PST efficacy in addressing both depressive symptoms and self-care in HF patients. This is due to 1) sample heterogeneity, as only 18% to 77% of the subjects in prior studies had HF, and 2) separate interventional foci, as HF information was not used to link depressed mood to impaired self-care. Characteristics of hospitalized HF patients such as timing and cognitive function were also not considered. The first three months after hospital discharge is the period when depressive symptoms are most likely to change and when impaired HF self-care is mostly likely to lead to rehospitalization. Moreover, more than half (54%) of older depressed HF patients have mild cognitive impairment that can lead to dementia, especially in the context of impaired self-care, uncontrolled HF and restricted cerebral blood flow. However, no PST interventions have been specifically provided in the post-discharge period or among HF patients with mild cognitive impairment. To date, there is no evidence regarding the efficacy of integrated PST interventions on both depressive symptoms and impaired self-care in HF patients after hospital discharge.

The ultimate goal of this research program is to prevent rehospitalization in HF patients using integrated PST interventions to simultaneously improve depressive symptoms and self-care. Built on the investigator's prior work with depressive symptoms in home health care (HHC), this study will examine the feasibility of a home-based, telephone-enhanced PST intervention (PST-HF) in these patients after hospital discharge.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • having a primary diagnosis of HF (New York Heart Association [NYHA] Class I, II, III) of the index hospitalization;
  • having clinically significant depressive symptoms (PHQ-9 score≥10) at both hospital discharge and four weeks after hospital discharge;
  • inadequate HF self-care ability (any domain score in the Self-Care of Heart Failure Index [SCHFI]≤70/100); and
  • having normal or mildly impaired cognitive function (score of Montreal Cognitive Assessment [MoCA]: 23-30).

排除标准

  • being listed for an implanted ventricular assist device, heart transplant or currently receiving Milrinone infusion (indicating decompensated HF);
  • receiving hospice care or end-of-life care;
  • having diagnoses of the following, a) delirium or advanced Alzheimer's disease, b) malignant cancer, coronary artery disease requiring surgery or angioplasty, renal disease on dialysis in the present or within the past two years, c) severe psychotic disorder or suicidal ideation (or scored "0" in PHQ-9 item #9);
  • initiation or titration of antidepressants in the past 8 weeks; or
  • inability to give informed consent and/or to communicate verbally in English.

结局指标

主要结局

Problem-solving skills

时间窗: 6 months post-discharge

problem solving skills as measured by the Social Problem-Solving Inventory-Revised (Short) SPSI-R:S: There are 25 items measuring 5 components: Positive Problem Orientation, Negative Problem Orientation, Rational Problem Solving, Impulsivity/Carelessness Style, and Avoidance Style. Validated norms are provided by age group and raw scores are plotted for conversion to standard scores. Higher scores reflect greater intensity of the construct measured.

次要结局

  • Heart Failure Self-care(6 months post-discharge)
  • Behavioral Activation for Depression(6 months post-discharge)
  • Depressive symptoms(6 months post-discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jinjiao Wang

Assistant Professor

University of Rochester

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