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临床试验/NCT01794728
NCT01794728已完成不适用

How the Elderly Live With Pain in Heart Failure

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Change in characteristics and frequency of pain in a cohort of HF patients

研究概览

简要总结

The How the Elderly Live with Pain in Heart Failure (HELP-HF) study provides the opportunity to assess the complaints of pain in a cohort of HF patient admitted to Thomas Jefferson University Hospital (TJUH). Additional information on their existing co-morbid conditions, an inventory of their prescribed medications, and details regarding the type of treatment interventions (over the counter analgesia and other comfort practices) they report using will be collected.

详细描述

Study Events Patients admitted to TJUH with a HF diagnosis will be identified by intensive clinical research coordinator screening methods. The potential subjects will be approached in the acute care area for interview and consent to participate. At that visit, the variables of interest will be collected and the questionnaires completed. Following discharge, the subjects will be re-interviewed at follow-up clinic visits or by telephone, depending on whether the visit is to a Jefferson University Physician provider or to an outside provider or as circumstances allow.

Subjects will sign an informed consent to participate in HELP-HF. A selection of assessment questionnaires (listed below) and performance measures will be completed during the index hospitalization and at a subsequent follow up clinic visits or by telephone call. Some of these assessments involve data collection from standard of care encounters or tests and will be abstracted from the medical record.

The Kansas City Cardiomyopathy Questionnaire (KCCQ) The KCCQ is a valid, reliable and responsive health status measure for HF patients and serves as a clinically meaningful outcome assessment tool that is widely used in cardiovascular research, patient management, and quality of life self-assessment.12 The Brief Pain Inventory (BPI) The BPI is one of the most widely used measurement tools for assessing clinical pain. It allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. Initially developed to assess pain related to cancer, the BPI has validated as an appropriate measure for pain caused by a wide range of clinical conditions. , The Charlson Co-Morbidity Index (CCI) Comorbidity describes the effect of all other diseases an individual patient might have other than the primary disease of interest. The CCI is used to characterize comorbid medical conditions and allows inferences about the extent to which symptoms and other factors related to quality of life may be attributable to conditions other than HF. The CCI designates comorbid conditions in 19 categories and each category has an associated weight based on the adjusted risk of one-year mortality, and the overall comorbidity score reflects the cumulative increased likelihood of one-year mortality. Charlson scores can range between 0 and 35, with a higher score indicating increase in burden of comorbid disease.

OTC Medication Inventory A comprehensive list of any over the counter (OTC) medications will be collected and reconciled via review of the electronic medical records and by subject interview.

Brief Interventions Measures (BIM) The BIM questionnaire is a novel tool developed for use in the HELP-HF study. It is adapted from similar questionnaires used in palliative oncology care and incorporates an inventory of comfort measure identified in the literature. These include measures like application of heat or cold, massage, and other self-selected therapies.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women ≥ 60 years.
  • Admission to hospital for worsening HF

排除标准

  • History of uncontrolled hypertension.
  • Severe valve disease.
  • End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support.
  • Advanced malignancy or other medical condition with life expectancy less than 2 years or undergoing active chemotherapy or radiation therapy.
  • Advanced chronic kidney disease (CKD) defined as estimated glomerular filtration rate (GFR) < 20 mL/min/1.73 m2 based upon the Modification of Diet in Renal Disease (MDRD) study equation), or on chronic or intermittent dialysis or dialysis anticipated within the next 6 months.
  • Chronic anemia with hemoglobin < 9 gm/dl for males, < 8 gm/dl for females or acute anemia requiring transfusion of 2 or more units of blood.

结局指标

主要结局

Change in characteristics and frequency of pain in a cohort of HF patients

时间窗: Time of enrollment date and after 30 days.

Assessment will be completed at baseline time of enrollment during hospitalization and again at 30 days after discharge. The instrument used is the Brief Pain Inventory questionnaire.

次要结局

  • Change in the analgesia and comfort measures selected to treat pain by a cohort of HF patients(Time of enrollment date and after 30 days.)
  • Change in the relationship between pain and self- reported QOL in a cohort of HF patients(Time of enrollment date and after 30 days.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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How the Elderly Live With Pain in Heart Failure | 临床试验