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临床试验/NCT05652413
NCT05652413已完成不适用

Enhancing Recruitment and Engagement of African American Older Adults With Osteoarthritis Pain in a Behavioral Pain Management and Physical Activity Intervention

Duke University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2023年1月9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
16
试验地点
2
主要终点
Number of enrolled participants

研究概览

简要总结

Physical activity like walking is one important way to reduce pain and improve wellbeing for older adults with knee and hip arthritis, but most older adults and particularly those who identify as African American struggle to walk regularly. Many African Americans with arthritis have worse outcomes (like worse pain, worse overall health) than other racial and ethnic groups for many reasons including racist policies and ideas that make getting good health care more difficult. It is therefore most important to identify ways to help older adults who identify as African American improve their arthritis pain and improve their daily steps. The current study is designed to learn about older African American's preferences for a brief behavioral intervention to increase daily steps and reduce pain, and to learn about the barriers (things that make walking harder) and facilitators (things that make walking easier) for walking that they experience. Interviews with both patients and healthcare providers will provide important information that will be used to adapt an existing behavioral intervention designed to help patients increase their daily steps and reduce their arthritis pain. The final adapted intervention will be tested in a small clinical trial with older adults who identify as African American to see if it can reduce pain and increase walking over time.

详细描述

Osteoarthritis is one of the most common risk factors for disability for African American older adults. Older adults who identify as African American experience more severe arthritis, higher pain levels, more pain related interference, more health problems that occur alongside arthritis, and have greater problems accessing appropriate and timely care for arthritis than other racial and ethnic groups. Physical activity can help improve pain and is safe even for older adults, but few older adults walk regularly due to pain, psychological distress, and other environmental barriers for walking. Specific strategies targeted to support older African Americans in walking more are needed. A previously tested behavioral intervention called Engage-PA has shown promise for supporting older adults with arthritis in the knee and/or hip. Yet little is know about how promising this intervention is for older African Americans, nor the specific barriers and facilitators for walking more for this population. Some specific components of Engage-PA may be particularly culturally-relevant for older African Americans, such as the use of personal values, or a detailed discussion of personally-identified meaning and purpose linked to daily walking routines. Older African Americans with arthritis and primary care providers treating arthritis at Duke Health have provided interview data to assist researchers in adapting Engage-PA to be more culturally sensitive. Adapted-Engage-PA will be tested with older African Americans who have knee and/or hip pain from osteoarthritis in a small feasibility and acceptability trial.

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

  • age 65 or older
  • English speaking
  • identify as Black/African American
  • diagnosis of osteoarthritis in knee or hip
  • able to ambulate even if assisted with walker or cane
  • endorse worst pain and pain interference as ≥ 3 out of 10 within the last week

排除标准

  • hearing or visual impairment that would prevent ability to participate in sessions or use participant worksheets, even with use of adaptive supports/devices
  • planned surgery during study duration that would limit mobility (e.g., due to recommended rehabilitation or recovery period) for more than 3 weeks
  • current enrollment in cardiac rehabilitation
  • myocardial infarction in the past 3 months
  • major surgery requiring limited movement or mobility for recovery within the past 3 months
  • presence of a serious psychiatric condition (e.g., schizophrenia, suicidal intent) that would contraindicate safe study participation
  • Medical provider indicating that exercise (even walking) should only be medically supervised
  • fall or falls within the last 3 months that led to immediate medical treatment/hospitalization
  • reported or suspected moderate or severe cognitive impairment
  • brain tumor/cancer metastases to the brain
  • no other conditions that would preclude safe participation (e.g., unmanaged heart conditions, neurodegenerative condition, unmanaged diabetes, severe respiratory disease), as screened the Physical Activity Readiness Questionnaire (PAR-Q+ 2020, a measure widely utilized by the U.S. National Academy of Sports Medicine and the Public Health Agency of Canada). Answers to the PARQ+2020 may result in review by patient physicians for safety prior to enrollment.

结局指标

主要结局

Number of enrolled participants

时间窗: 6 months

Did the study reach full anticipated accrual?

Percentage of participants who were mostly or very satisfied with the intervention

时间窗: Post-treatment (8 weeks)

Client Satisfaction Questionnaire asks 8 questions related to patient satisfaction on a Likert Scale of 1= very satisfied to 7 = very dissatisfied. There is one item assessing overall satisfaction with the intervention, and the percentage of participants responding to this item with "mostly" or "very" satisfied is reported below.

Number of participants who completed the entire program

时间窗: 8 weeks

Participants who complete all assessments and required study sessions

次要结局

  • Psychological Flexibility(Baseline, post-treatment (8 weeks))
  • Valued Living - Health Domain(Baseline, post-treatment (8 weeks))
  • Arthritis Pain (AIMS 2 Symptom Subscale)(Baseline, post-treatment (8 weeks))
  • Step Count(Baseline, post-treatment (8 weeks))
  • Valued Living - Leisure Domain(Baseline, post-treatment (8 weeks))
  • Psychological Distress (AIMS 2 Affect Subscale)(Baseline, post-treatment (8 weeks))
  • Rapid Assessment of Physical Activity(Baseline, post-treatment (8 weeks))
  • Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)(Baseline, post-treatment (8 weeks))
  • Valued Living -Relationship Domain(Baseline, post-treatment (8 weeks))
  • Valued Living -Work/Community Domain(Baseline, post-treatment (8 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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