Duke University Medical Center
Durham, North Carolina, 27705, United States
Location status: Recruiting
Location contact
Katherine Ramos, Ph.D
PRINCIPAL_INVESTIGATOR
Laura Porter, Ph.D
CONTACT
Laura Porter, Ph.D
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06854718
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).
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27705, United States
Location status: Recruiting
Katherine Ramos, Ph.D
PRINCIPAL_INVESTIGATOR
Laura Porter, Ph.D
CONTACT
Laura Porter, Ph.D
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients:
Caregivers:
Exclusion criteria
Patient and caregivers
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.
Time frame: Post-intervention (approximately 8 weeks)
Caregiver completes. Score range: 1-4; higher score indicates better outcome
Time frame: Baseline and post-intervention (approximately 8 weeks)
Patient and Caregiver will complete Patient QOL. Score range: 13-52; higher score indicates better outcome
Time frame: Baseline and post-intervention (approximately 8 weeks)
Patient and Caregiver will complete Patient pain interference. Score range: 0-10; higher score indicates worse outcome
Time frame: Baseline and post-intervention (approximately 8 weeks)
Caregiver will complete caregiver self-efficacy. Score range: 0-10; higher score indicates better outcome
Time frame: Baseline and post-intervention (approximately 8 weeks)
Patient will complete patient pain intensity. Score range: 0-19; higher score indicates worse outcome
Time frame: Baseline and post-intervention (approximately 8 weeks)
Caregiver will complete patient pain intensity. Score range: 0-10; higher score indicates worse outcome
Time frame: Baseline and post-intervention (approximately 8 weeks)
Caregivers will complete caregiver burden. Score range: 0-88; higher score indicates worse outcome
Time frame: Baseline and post-intervention (approximately 8 weeks)
Caregiver will complete caregiver satisfaction. Score range: 0-10; higher score indicates worse outcome
Time frame: Baseline and post-intervention (approximately 8 weeks)
Caregiver will complete patient neuropsychiatry behaviors. Score range: 0-144; higher score indicates worse outcome
Contact information is provided by the study sponsor or research team.
Katherine Ramos, Ph.D
CONTACT
Laura Porter, Ph.D
CONTACT
Duke University
Other
Caregiver-assisted Pain Coping Skills Training for Dementia Pilot Study
Acronym: PWD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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