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临床试验/NCT06854718
NCT06854718招募中不适用

Caregiver-assisted Pain Coping Skills Training for Dementia Pilot Study

Duke University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Client Satisfaction Questionnaire

研究概览

简要总结

The purpose of the study is to develop a caregiver-assisted pain coping skills training program for older adults who have pain and mild to moderate dementia and are living at home with a family caregiver. The investigators are planning to recruit 30 patient-caregiver dyads (60 individuals).

详细描述

Involving caregivers in a pain coping skills protocol is likely to optimize treatment outcomes in several ways.

First, people with dementia (PWD) are likely to have difficulty learning and remembering pain coping skills; training the caregiver to coach the patient in the use of the skills is likely to improve the patients' acquisition and ongoing use of learned skills.

Second, caregiver involvement in pain coping skills training may increase their understanding of how to gauge how much pain the PWD is experiencing and the impact of pain management strategies. This understanding is increasingly important as the patient's disease progresses, and s/he is less able to report pain verbally.

Third, caregiver-assisted pain management training may enhance caregivers' self-confidence for managing the patient's pain.

Finally, by participating in the pain coping skills training protocol, caregivers may learn coping skills (such as relaxation) that can help them manage the stress associated with caring for a PWD and pain which can be significant.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mild or moderate dementia
  • Pain on most days for at least 3 months that interferes with function
  • Living at home (non-institutional)
  • English Speaking
  • Caregivers:
  • Provides on average at least 4 hours/day of care/assistance to the patient
  • English Speaking

排除标准

  • Patient and caregivers
  • Lacking capacity for interview or unable to provide informed consent/assent.
  • Visual or hearing impairments or severe behavioral problems that preclude participation.
  • Too sick to participate.

研究组 & 干预措施

Patient-Caregiver Dyads

Other

Patient and caregiver dyads will receive five 45-60 minute sessions over 6-8 week period. This will be over videoconference with a masters-level therapist. All sessions will be audio recorded.

干预措施: Caregiver-Assisted Pain Coping Skills Training (CG-PCST) (Behavioral)

结局指标

主要结局

Client Satisfaction Questionnaire

时间窗: Post-intervention (approximately 8 weeks)

Caregiver completes. Score range: 1-4; higher score indicates better outcome

次要结局

  • Quality of life in Alzheimer's Disease Caregiver version and Patient version(Baseline and post-intervention (approximately 8 weeks))
  • Brief Pain Inventory-Interference Items(Baseline and post-intervention (approximately 8 weeks))
  • Caregiver Self-Efficacy in Pain Management(Baseline and post-intervention (approximately 8 weeks))
  • Numeric pain scale & verbal descriptor(Baseline and post-intervention (approximately 8 weeks))
  • Checklist of nonverbal pain indicators(Baseline and post-intervention (approximately 8 weeks))
  • Zarit burden interview(Baseline and post-intervention (approximately 8 weeks))
  • Caregiver appraisal-satisfaction scale(Baseline and post-intervention (approximately 8 weeks))
  • Neuropsychiatric inventory(Baseline and post-intervention (approximately 8 weeks))

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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