Pain With Dementia (PWD)

Duke University

Status: Enrolling

Conditions: Dementia, Moderate; Dementia, Mild; Pain

Treatments: Behavioral: Caregiver-Assisted Pain Coping Skills Training (CG-PCST)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06854718

1R61AG088938-01 (U.S. NIH Grant/Contract)

Pro00116129

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Patient-Caregiver Dyads

Other group

Description:

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.

Treatment:

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