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临床试验 NCT06264362 针对慢性疼痛,轻度痴呆,活动受限,身体残疾,膝骨关节炎,轻度认知障碍目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。
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Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia

尚未招募
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临床试验NCT06264362是一项针对慢性疼痛,轻度痴呆,活动受限,身体残疾,膝骨关节炎,轻度认知障碍干预性研究试验,当前状态为尚未招募试验尚未开始,计划于2025年6月2日开始,预计招募40名患者。该研究由德雷塞尔大学主导,计划于2027年5月1日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2025年3月11日
简要概括
The purpose of this study is to develop an exercise treatment program for knee osteoarthritis that works well for people with memory problems. This study will include two parts. Participants can choose to participate in either or both parts.

In Part 1 (not a clinical trial) - The investigators are inviting the following people to participate in an interview:

  1. Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain.
  2. Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly.
  3. Clinicians (exercise physiologists or rehabilitation therapists like physical and occupational therapists) who have worked with older adults with memory issues and knee pain.

The goal of these interviews is to learn from the experiences of people with memory issues and knee pain and those who care for them. From these interviews, the investigators hope to design a non-drug, tailored physical activity program that will be interesting and helpful in managing knee pain for older adults with memory problems.

For people with memory problems and knee pain and their care partners: The investigators will ask some questions to determine eligibility to participate in the study.

Those who qualify for the study will be invited to participate in an interview that could be completed online or in person (Philadelphia, PA). The interview could last up to 90 minutes (1 and a half hours) and can be completed as one or multiple sessions.

For clinicians: Participants will engage in a 90-minute focus group with other clinicians where lunch will be served if in person. Those participating in an online focus group will receive a gift card equal to the value of lunch.

In Part 2 (a clinical trial) - The program developed in Part 1 will be tested. The program will be physical activity-based. Specific program details for part 2 will be provided as they emerge. Participants can choose to sign up for either or both parts. Signing up for Part 1 does not mean participants have to sign up for Part 2.

Please contact us for any questions.

详细描述
Chronic musculoskeletal pain, specifically osteoarthritis (OA) of the knee, is common among community-dwelling people living with memory issues and associated with cascading negative consequences on physical function limitations, quality of life decline, and caregiver burden; however, few beneficial and appropriate treatment options exist. This study seeks to use evidence, theory, and stakeholder input to design an exercise-based intervention for knee OA pain management tailored to the interests, preserved abilities, and biopsychosocial-environmental needs of community-dwelling older adults with mild to very mild dementia. Findings from K23 research will yield a nonpharmacological intervention prototype and delivery parameters that will inform a future efficacy study and have a strong potential for preserving or improving the quality of life of community-dwelling older adults with dementia and OA.
官方标题

Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia

疾病
慢性疼痛轻度痴呆活动受限身体残疾膝骨关节炎轻度认知障碍
出版物
关于此临床试验发表的科学文章和研究论文:
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其他研究标识符
NCT编号
实际开始日期
2025-06-02
最近更新发布
2025-03-11
预计完成日期
2027-05-01
计划入组人数
40
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
pain
dementia
cognitive impairment
osteoarthritis
knee pain
memory
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无(开放性试验)
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性Tailored Physical Activity Program for Pain
Specific characteristics of the intervention delivered in Phase 2 will be based on the information gathered from stakeholders in Phase 1.
Tailored Physical Activity Program
Adaptation of physical activity as an intervention for pain management using the 3-Step Tailored Approach: assessing in Step 1 the Person Living with Dementia (PLWD), in Step 2 the Environment, and in Step 3 the Caregiver. With this approach, traditional exercises can be adapted to 1) functional activities (e.g., stair climbing) that are tailored to the interests (e.g., dancing, boxing) and preserved abilities of PLWD; 2) preferred and well-tolerated environments (e.g., home); and 3) account for extent and type of interventionist and caregiver involvement.
主要终点
结果指标度量标准描述时间框架
Program parameters
Qualitative interviews to determine preferred program parameters.
Day 1
Program parameters
Focus groups of clinicians to determine preferred program parameters.
Day 1
Feasibility of Intervention Measure
The Feasibility of Intervention Measure is a standardized 4-question self-reported outcome measure to assess feasibility. Each item is scored on a 5-point scale, where 1 = completely disagree, 2 = disagree, 3 = neither agree or disagree, 4 = agree, 5 = completely agree. The responses are summed and range between 5 to 20, with higher scores indicating greater feasibility. A score of 16 or greater suggests the program is feasible, 15 to 9 indicates the program may be feasible, and a score of 8 or less suggests the program is not feasible.
At study completion, an average of 8 weeks
Perception of program
Qualitative Interview of all who participated in the program to determine components of the intervention prototype that needs revising
At study completion, an average of 8 weeks
次要终点
结果指标度量标准描述时间框架
Numeric Pain Score
A self-reported pain measurement ranging from 0 (no pain) to 10 (worst pain). A high score indicates more pain.
Through study completion, an average of 8 weeks.
Zarit Burden Interview-Short Form
Zarit Burden Interview-Short Form is a12-item questionnaire to assess the burden of caregiving using a 5-point scale where 0 (never) to 4 (almost always). Scores are summed, ranging from 0-48, where a higher score indicates a greater caregiver burden.
At study completion, an average of 8 weeks
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
60 Years
适龄性别
全部
  • Age 60 or older
  • Speaks English
  • Mild/Very Mild dementia
  • Knee pain lasting ≥ 3 months, potentially related to arthritis
  • Knee pain is at least 2 out of 10 on average.

  • Reside in long term care facility
  • Unable or unwilling to consent
  • Has a condition with a life expectancy of less than 1-year
  • No care partner who is also willing to participate
  • Recent changes to pain or psychotropic medications in the last 60 days
  • Recent knee surgery in the last 1-year
  • Has a condition that contraindicates exercise (Phase 2 only)
  • Currently receiving rehab services (Phase 2 only)

For care partners:

  • No sex, gender, or age criteria
  • Has known person living with dementia ≥ 1 year
  • Speaks English
  • Able and willing to consent, including being recorded

For clinicians:

  • No sex, gender, or age criteria
  • Speaks English
  • Has ≥ 2 years of experience working with community-dwelling people with dementia and pain
  • Able and willing to consent, including being recorded
National Institute on Aging (NIA) logoNational Institute on Aging (NIA)
研究中心联系人
联系人: Annalisa Na, PT, PhD, 2673595889, [email protected]
联系人: Ben Senderling, 2673595655, [email protected]
1 位于 1 个国家/地区的研究中心

Pennsylvania

Drexel University, Philadelphia, Pennsylvania, 19104, United States
Annalisa Na, PT, PhD, 联系人, 267-359-5889, [email protected]
Ben Senderling, MS, 联系人, 2673595655, [email protected]