Pain With Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorDuke University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mild or moderate dementia
Pain on most days for at least 3 months that interferes with function
Living at home (non-institutional)
Age ≥ 50
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Patient-Caregiver DyadsOther 1 intervention
Trial outcomes
Primary outcomes
1
Client Satisfaction Questionnaire
Caregiver completes. Score range: 1-4; higher score indicates better outcome
Time frame
Post-intervention (approximately 8 weeks)Secondary outcomes
1
Quality of life in Alzheimer's Disease Caregiver version and Patient version
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)2
Brief Pain Inventory-Interference Items
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)3
Caregiver Self-Efficacy in Pain Management
Caregiver will complete caregiver self-efficacy. Score range: 0-10; higher score indicates better outcome
Time frame
Baseline and post-intervention (approximately 8 weeks)4
Numeric pain scale & verbal descriptor
Patient will complete patient pain intensity. Score range: 0-19; higher score indicates worse outcome
Time frame
Baseline and post-intervention (approximately 8 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov