Caregiver-assisted Pain Coping Skills Training for Dementia Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Client Satisfaction Questionnaire
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Mild or moderate dementia
- •Pain on most days for at least 3 months that interferes with function
- •Living at home (non-institutional)
- •English Speaking
- •Caregivers:
- •Provides on average at least 4 hours/day of care/assistance to the patient
- •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.
Arms & Interventions
Patient-Caregiver Dyads
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.
Intervention: Caregiver-Assisted Pain Coping Skills Training (CG-PCST) (Behavioral)
Outcomes
Primary Outcomes
Client Satisfaction Questionnaire
Time Frame: Post-intervention (approximately 8 weeks)
Caregiver completes. Score range: 1-4; higher score indicates better outcome
Secondary Outcomes
- 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))
- Zarit burden interview(Baseline and post-intervention (approximately 8 weeks))
- Caregiver appraisal-satisfaction scale(Baseline and post-intervention (approximately 8 weeks))
- Neuropsychiatric inventory(Baseline and post-intervention (approximately 8 weeks))