Pain With Dementia
Part of paid clinical trials in Durham, North Carolina.
- Sponsor
- Duke University
- Study ID
- NCT06854718
- Status
- Recruiting
Conditions
- Dementia, Mild
- Dementia, Moderate
- Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Caregiver-Assisted Pain Coping Skills Training (CG-PCST) — BEHAVIORALPatient-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.
Study Details
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).
Key Dates
- Start date
- Aug 13, 2025
- Status verified
- Jun 2025
- Primary completion
- Dec 1, 2026
- Completion
- Dec 1, 2026
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Other: Patient-Caregiver DyadsPatient 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.
Primary Outcome Measure
Client Satisfaction Questionnaire [ Time Frame: Post-intervention (approximately 8 weeks) ]
Central Contacts
- Laura Porter, Ph.D919-416-3436
- Katherine Ramos, Ph.D919-416-3434
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | Laura Porter, Ph.D (PRINCIPAL_INVESTIGATOR) Katherine Ramos, Ph.D (PRINCIPAL_INVESTIGATOR) |
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