Clinical trial NCT06854718: Pain With Dementia
Official title: Caregiver-assisted Pain Coping Skills Training for Dementia Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Dementia, Mild
Dementia, Moderate
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
First posted: 2025-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Patients:

* Mild or moderate dementia
* Pain on most days for at least 3 months that interferes with function
* Living at home (non-institutional)
* Age ≥ 50
* English Speaking

Caregivers:

* Provides on average at least 4 hours/day of care/assistance to the patient
* Age ≥ 18
* English Speaking

Exclusion Criteria:

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.

Primary outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: Post-intervention (approximately 8 weeks)
Secondary outcomes:
measure: Quality of life in Alzheimer's Disease Caregiver version and Patient version
timeFrame: Baseline and post-intervention (approximately 8 weeks)
measure: Brief Pain Inventory-Interference Items
timeFrame: Baseline and post-intervention (approximately 8 weeks)
measure: Caregiver Self-Efficacy in Pain Management
timeFrame: Baseline and post-intervention (approximately 8 weeks)
measure: Numeric pain scale & verbal descriptor
timeFrame: Baseline and post-intervention (approximately 8 weeks)
measure: Checklist of nonverbal pain indicators
timeFrame: Baseline and post-intervention (approximately 8 weeks)
measure: Zarit burden interview
timeFrame: Baseline and post-intervention (approximately 8 weeks)
measure: Caregiver appraisal-satisfaction scale
timeFrame: Baseline and post-intervention (approximately 8 weeks)
measure: Neuropsychiatric inventory
timeFrame: Baseline and post-intervention (approximately 8 weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Laura Porter, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: