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临床试验/NCT03285958
NCT03285958已完成不适用

Promoting Physical Activity for Chronic Pain Management Among Older Adults in Detroit: Comparing Technology-Based Strategies

University of Michigan2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2017年11月16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
57
试验地点
2
主要终点
Adherence to Step Count Reporting - SMS

研究概览

简要总结

Wearable, commercially-available physical activity monitors are being increasingly incorporated into chronic pain self-management interventions as a tool to help patients set goals and to tailor intervention content based on patient progress. Yet older adults from resource-challenged communities may face significant barriers to using these monitors and reporting activity data. Our pilot study will focus on wearable monitor use among older adults in Detroit with chronic musculoskeletal pain, testing the feasibility and validity of various technology-based strategies for reporting daily step count data. The study will also assess whether six weeks of monitor use is associated with improvements in functioning, relative to a control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Age > 60 years
  • Ambulatory with or without assistive device
  • Community living
  • Have a SMS-capable cell phone
  • Internet access (via smartphone, in-home or elsewhere);
  • Self-reported chronic musculoskeletal pain (pain in muscles or joints for > 3 months)
  • >4 (0-10 scale) average pain level over last week
  • >1 day/previous 30 when pain made it difficult to do usual activities
  • Ability to travel to study location in Detroit for a one-time session
  • Exclusion criteria:
  • Serious acute illness or hospitalization in last month
  • Planned surgery in next month
  • Severe cognitive impairment

排除标准

  • 未提供

结局指标

主要结局

Adherence to Step Count Reporting - SMS

时间窗: Two weeks

Proportion of days that step count was successfully provided/possible reporting days for SMS

Change in Pain Interference

时间窗: Baseline, eight weeks

The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference 4-item subscale, where a higher score indicates more pain interference. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much). Raw scores are converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation). The possible range is 42 to 76, with a higher score representing worse outcome.

Adherence to Step Count Reporting - IVR

时间窗: two weeks

Proportion of days that step count was successfully provided/possible reporting days for IVR.

Adherence to Step Count Reporting - Sync

时间窗: two weeks

Proportion of days that step count was successfully provided/possible reporting days for syncing with app

次要结局

  • Change in Social Participation(Baseline, eight weeks)
  • Validity of Manually-reported Step Count Data - SMS(Two weeks)
  • Change in Physical Functioning(Baseline, eight weeks)
  • Validity of Manually Reported Step Count Data - IVR(Two weeks)

研究者

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

Mary Janevic

Assistant Research Scientist

University of Michigan

研究点 (2)

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