Pain With Dementia

NCT06854718 | Recruiting DMC

• 2 other identifiers: Pro001161291R61AG088938-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain; Dementia, Mild; Dementia, Moderate

Outcome Measures

Primary Outcomes (1)

• Client Satisfaction Questionnaire

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

  Post-intervention (approximately 8 weeks)

Secondary Outcomes (8)

• 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)

Study Arms (1)

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.

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

Interventions

Caregiver-Assisted Pain Coping Skills Training (CG-PCST) BEHAVIORAL

Patient-caregiver dyads will receive five, forty-to-sixty-minute sessions over a six-to-eight-week period with a therapist to learn pain coping skills. These include training caregivers in strategies for assessing patient pain, including nonverbal pain behaviors (e.g., grimacing, bodily tension, labored breathing), which will become increasingly important as the patient's ability to express pain verbally decreases. The therapist will also train the caregiver to coach the patient in the use of the skills during activities that are challenging because of pain. We will focus on increasing positive patient-caregiver interactions and patient engagement in valued activities. Throughout the training, the therapist will help the patient and caregiver learn strategies for fostering regular home practice and application of the skills, identify challenges in using the skills, and find strategies for coping with challenges.

Patient-Caregiver Dyads

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Pain; Dementia; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Laura Porter, Ph.D

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Porter, Ph.D

CONTACT

919-416-3436; Laura.Porter@duke.edu

Katherine Ramos, Ph.D

CONTACT

919-416-3434; Katherine.Ramos@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 3, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)