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临床试验/NCT03517514
NCT03517514已完成不适用

Investigating All-Cause 30-Day Hospital Readmisisons in Patients Discharged From a Tertiary Teaching Hospital With Acute Decompensated Heart Failure Diagnosis

The Methodist Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
hospital readmission within 30 days

研究概览

简要总结

This is a dissertation study which is divided into three different studies in order to answer the main research question (Study 3). The primary aim of this research (dissertation) is to investigate all-cause 30-day hospital readmission using functional mobility (5mWT, 30STS, 6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence to home exercise program, participation in a supervised exercise program, and number of follow up checkups with physicians or advanced health providers of patients with Acute Decompensated Heart Failure (ADHF) diagnosis who were discharged from a tertiary teaching hospital.

Study 1: What is the effect of acute physical therapy on functional ability in individuals admitted with ADHF? Study 2: What is the effect of acute physical therapy on psychosocial attributes in individuals admitted with ADHF? Study 3: Which factors such as functional mobility (5mWT, 30STS, 6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence to home exercise program, participation in a supervised exercise program, and number of follow up checkups with physicians or advanced health providers predict all-cause 30-day hospital readmission in patients discharged from a tertiary, teaching hospital with ADHF diagnosis?

详细描述

The research plan is to investigate how acute physical therapy can play a big role in lowering 30-day hospital readmission in patients discharged with acute decompensated heart failure (ADHF). Several factors will be used to investigate and predict 30-day hospital readmission. Such factors are (1) functional mobility; 2) psychosocial attributes; (3) number of follow ups with providers; (4) adherence to home exercise program; (5) and participation in a supervised exercise program. Functional mobility will be measured by four different functional outcome measurements such as 5 meter walk test (5mWT), 30 seconds sit to stand test (30STS), six minute walk test (6MWT), and time up and go test (TUG). The psychosocial attributes will be measured by three different, pen and paper, self-survey questionnaires namely Kansas City Cardiomyopathy Questionnaire-12 (KCCQ12), Hospital Anxiety and Depression Scale (HADS), ENRICHD Social Support Instrument (ESSI). Moreover, once the patient returns home, two phone surveys will be conducted (every two weeks) for a period of 30 days of hospital discharge as a follow up.

For the outcome measurements, the 5mWT is a simple test to measure individual's gait (walking) speed. The 30STS is a simple and easy test to complete in assessing functional lower extremity strength. The 30STS asks individual to stand up (assuming erect posture as much as possible with or without hands support) as many as possible from a regular chair with arm rest within 30 seconds timeframe. The 6MWT is simple and practical test is to measure aerobic capacity by measuring distance of an individual's ability to walk for 6 minutes. The TUG is to measure the time in seconds for a person to rise from sitting from a standard arm chair, rise, walk 10 feet, walk back to the previous arm chair, and sit down. The objective of the TUG test is to classify patient's fall risk. In addition, the functional mobility, basing on the functional outcome measures conducted, will be further assessed at the end of physical therapy service at the hospital by using Global Rating of Scale (GROC). The GROC is a self-survey using 5 point Likert scale, measuring how patient perceives the overall degree of change of improvement or perhaps a lack of improvement.

For the Psychosocial Measures, the Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 is a shorter version of the original KCCQ tool. The objective of this test is to quantify self-measurement of physical function, symptoms, social function, self-efficacy and knowledge, and quality of life as it relates to their own heart failure diagnosis. The Hospital Anxiety and Depression Scale (HADS) is a self-reported questionnaire designed to measure the levels of anxiety and depression that an individual is experiencing. The objective of this tool is to serve as a screening tool to identify individuals who may suffer from anxiety and depression. The ENRICHD Social Support Instrument (ESSI) is a seven-item self-report survey that assesses patient's belief of their social support attributes (emotional, instrumental, informational, and appraisal).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • all admitted at Houston Methodist Hospital with a primary diagnosis of acute heart failure or similar type of medical diagnosis
  • stable medical state (HR equal or greater than 50 bpm, mean BP of 60 mmHg or better, Oxygen saturation (with or without oxygen supplement) of 90% or better; RR of 15 or better
  • 50 years old and over and able to follow 2 simple commands
  • establish discharge recommendation to home settings
  • ambulatory with or without assitive device(s)

排除标准

  • history of psychiatric disorder
  • diagnosis of acute kidney injury requiring continuous renal replacement therapy
  • diagnosis of major cognitive impairment (dementia, Alzheimer's dse, etc)
  • inability to read and understand basic english language
  • establish discharge recommendation to post-acute care settings (e.g. SNF, inpatient rehab, LTACH)
  • inability to complete any functional mobility test due to musculoskeletal or other disorders

结局指标

主要结局

hospital readmission within 30 days

时间窗: less than or equal to 30 days

Identification of patient hospital readmission within 30 days of discharge (day 0).

次要结局

  • Six Minute Walk Test (6MWT)(Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks))
  • 30 seconds Sit to Stand Test (30STS)(Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks))
  • Five Meter Walk Test (5mWT)(Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks))
  • Time Up and Go Test of Fall Risk (TUG)(Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks))
  • Global Rating of Change Scale (GROC)(End of study (post-physical therapy; defined as time frame: Day 2 to 8 weeks))

研究者

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

Bobby Belarmino PT,DPT,MA

Senior Physical Therapist (Level IV)

The Methodist Hospital Research Institute

研究点 (1)

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