Treating Pain to Reduce Disability Among Older Home Health Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 658
- 试验地点
- 1
- 主要终点
- Improvement on Performance-Based Measures of Functioning Among Intervention Patients
研究概览
简要总结
The overall goal of this real-world comparative effectiveness research (CER) study is to reduce disability among older home health patients by treating their pain more effectively. To achieve this goal the investigators will conduct a cluster randomized controlled trial of a physical therapist (PT) delivered intervention provided to VNSNY home health care patients with activity-limiting pain. The intervention is an evidence-based non-pharmacological program to reduce pain and pain-related disability that utilizes cognitive-behavioral pain self-management (CBPSM) techniques.
详细描述
This project will compare the effectiveness of usual care provided to older home health patients admitted with activity-limiting pain to usual care plus instruction by PTs in CBPSM techniques. The project also will examine differences in the effectiveness of the intervention among different race/ethnicity groups and individuals with different pain types, as well as the fidelity of intervention-group PTs to the CBPSM program.
The specific aims of this CER study that will include sizeable numbers of Hispanics, non-Hispanic African Americans and non-Hispanic white patients ages 55 and older are: (1) to compare the effectiveness of usual care provided to older home health patients admitted with activity-limiting pain to usual care plus instruction by PTs in CBPSM techniques; and (2) to examine the heterogeneity of CBPSM treatment effects among patients with different pain conditions and minority group status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •VNSNY patient in the adult home healthcare program
- •Services are being provided in the Bronx, Brooklyn, Manhattan, Queens, Staten Island, Nassau or Westchester
- •VNSNY Plan of Care includes physical therapy
- •Age 55 or older
- •Speaks English
- •Has a telephone
- •Activity-limiting pain
排除标准
- •Significant cognitive impairment
研究组 & 干预措施
Usual Care
Usual Physical Therapy Plan of Care
干预措施: Cognitive-Behavioral Pain Self-management Program (Behavioral)
Usual Care Plus Pain Management Program
Behavioral: Cognitive-Behavioral Pain Self-management Program.
干预措施: Cognitive-Behavioral Pain Self-management Program (Behavioral)
结局指标
主要结局
Improvement on Performance-Based Measures of Functioning Among Intervention Patients
时间窗: Baseline/Intake and 60 day follow up
Patients receiving usual care plus the intervention when compared with participants receiving usual care only will demonstrate (1) Significantly better results as measured by the Timed Up and Go test; Timed Chair Stands, and Timed Foot Taps test;(2) Significantly better ADL functioning;(3) Significantly reduced levels of pain-related disability as measured by the Roland Morris Disability Questionnaire; and (4) Significantly reduced levels of pain intensity and increased levels of pain relief as measured by the Brief Pain Inventory.
次要结局
- Lower Rates of Service Utilization Within Intervention Group(60 day follow up survey)