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临床试验/NCT02906358
NCT02906358已完成不适用

Evaluating Clinic- and Community-Based Pain Self-Care Programs for Low-Income Hispanics on Opioids

The University of Texas Health Science Center at San Antonio0 个研究点目标入组 111 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
111
主要终点
Five Times Sit-to-stand (5XSTS)

研究概览

简要总结

The purpose of this study is to conduct a parallel group, randomized trial of a chronic pain self-management program in clinic or community settings to educate and support low-income, Hispanic patients with chronic pain to adopt evidence-based pain self-care behaviors and activities.

详细描述

Background and Significance

Over the past two decades, opioid analgesic (OA) drugs have been increasingly prescribed for chronic pain despite little to no effectiveness of treatment >6 months. In prospective cohorts, OA therapy can worsen pain and disability by promoting a sedentary lifestyle. With rapidly rising deaths from OA overdose and the lack of evidence of long-term effectiveness, the U.S. Department of Health and Human Services (HHS) has developed its National Pain Strategy that sharply limits use of OAs and recommends non-pharmacologic interventions as first line approaches to manage chronic pain. A key aspect of a non-pharmacologic approach to managing chronic pain is educating patients about self-management in order to help them lead more productive lives and perform daily activities despite their pain. Self-management training is especially important for low-income patients who need practical, low cost ways to learn how to live fuller, more productive lives despite having chronic pain. To respond to this need to support low-income patients with chronic pain, we developed a chronic pain self-management program based on unmet needs identified by stakeholders from rural, largely Hispanic communities. We conducted a randomized trial to examine outcomes of two settings to deliver this self-management training program. Both settings evaluated whether patients' function improved when the same program was delivered in clinic in individual meetings with a trained community health worker or in a local community-based setting from group lectures by content experts. The training program in both settings offered education and training about such topics as: pain physiology and goal setting; stretching; strengthening; massage, and mindfulness techniques. This program not only reflects the unmet needs of rural, predominantly Hispanic stakeholders with chronic pain but also elements of other self-management programs for patients with chronic back and lower extremity musculoskeletal pain. However, this program was specifically designed for a low literacy, bilingual patient population with limited access to resources to help with non-pharmacologic management of chronic pain.

Objective:

To develop a chronic pain self-management program reflecting community stakeholders' priorities and conduct a randomized trial to evaluate functional outcomes from training in two settings. Subjects will be randomized to receive a 6-month pain self-management training program in: 1) Six 30-to-45 minute individual meetings with a trained community health worker in clinic or 2) nine 1-hour meetings for group lectures by content experts and practicing physical activities held in nearby public libraries.

Study Design:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Active patient in two study primary care clinics or HIV clinic in same system
  • •Prescribed OAs >2 mos in the past year
  • •Back/lower extremity pain
  • •English or Spanish speaking

排除标准

  • •Unstable comorbidity
  • •Cardiovascular/pulmonary disease that prevents exercise
  • •Cancer-related pain
  • •Significant mental health disorder
  • •Alcohol or drug abuse
  • •Inability to walk unassisted for at least one block
  • •Inability to provide consent (e.g., dementia)
  • •Residing more than 10 miles from clinic (poor transportation)
  • •Patients who are unable or unwilling to attend clinic- or community-based sessions

研究组 & 干预措施

Community-based pain self-management

Active Comparator

Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)

干预措施: Community-based pain self-management (Behavioral)

Clinic-based pain self-management

Active Comparator

Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)

干预措施: Clinic-based pain self-management (Behavioral)

结局指标

主要结局

Five Times Sit-to-stand (5XSTS)

时间窗: Change from Baseline sit-to-stand at 3 and 6 months

Participants are instructed to sit and stand up five times as fast as they can from a standard armless chair while the researcher times how many seconds it takes them to complete the task. After a brief rest, they repeat the test a second time and the average of two tests is calculated.

次要结局

  • 50-foot Speed Walk (50FtSW)(Change from Baseline 50-foot speed walk at 3 and 6 months)
  • The Brief Pain Inventory (BPI): Severity(Change from Baseline BPI at 3 and 6 months)
  • Borg Perceived Effort (Borg)(Change from Baseline perceived effort at 6 months)
  • 6-minute Distance Walk (6MW)(Change from Baseline 6-minute distance walk at 6 months)
  • Medical Outcomes Study 12-Item Short Form Physical Component Summary (SF-12 PCS)(Change from Baseline SF-12 PCS at 6 months)
  • Medical Outcomes Study 12-Item Short Form Mental Component Summary (SF-12 MCS)(Change from baseline SF-12 MCS at 6 months)
  • Patient Health Questionnaire -9 (PHQ-9)(Change from Baseline PHQ-9 at 6 months)
  • Patient Specific Functional Scale (PSFS)(Change from Baseline PSFS at 3 and 6 months)
  • Symbol-Digit Modalities Test (SDMT)(Change from Baseline SDMT at 3 and 6 months)
  • Tampa Scale for Kinesiophobia (TSK)(Change from Baseline TSK at 6 months)
  • The Brief Pain Inventory (BPI): Interference(Change from Baseline BPI at 3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

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