Pain With Dementia

Not Applicable

Recruiting

• Conditions: Pain; Dementia, Mild; Dementia, Moderate

• Registration Number: NCT06854718
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-25
• Study First Posted: 2025-03-03
• Status Verified: 2025-04
• Study Start: 2025-04-29
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire	Post-intervention (approximately 8 weeks)	Caregiver completes. Score range: 1-4; higher score indicates better outcome

Secondary Outcome Measures

Name	Time	Method
Quality of life in Alzheimer's Disease Caregiver version and Patient version	Baseline and post-intervention (approximately 8 weeks)	Patient and Caregiver will complete Patient QOL. Score range: 13-52; higher score indicates better outcome
Brief Pain Inventory-Interference Items	Baseline and post-intervention (approximately 8 weeks)	Patient and Caregiver will complete Patient pain interference. Score range: 0-10; higher score indicates worse outcome
Caregiver Self-Efficacy in Pain Management	Baseline and post-intervention (approximately 8 weeks)	Caregiver will complete caregiver self-efficacy. Score range: 0-10; higher score indicates better outcome
Numeric pain scale & verbal descriptor	Baseline and post-intervention (approximately 8 weeks)	Patient will complete patient pain intensity. Score range: 0-19; higher score indicates worse outcome
Checklist of nonverbal pain indicators	Baseline and post-intervention (approximately 8 weeks)	Caregiver will complete patient pain intensity. Score range: 0-10; higher score indicates worse outcome
Zarit burden interview	Baseline and post-intervention (approximately 8 weeks)	Caregivers will complete caregiver burden. Score range: 0-88; higher score indicates worse outcome
Caregiver appraisal-satisfaction scale	Baseline and post-intervention (approximately 8 weeks)	Caregiver will complete caregiver satisfaction. Score range: 0-10; higher score indicates worse outcome
Neuropsychiatric inventory	Baseline and post-intervention (approximately 8 weeks)	Caregiver will complete patient neuropsychiatry behaviors. Score range: 0-144; higher score indicates worse outcome

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States