Pain With Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caregiver-Assisted Pain Coping Skills Training (CG-PCST).
- Who it may be relevant to
- Registry conditions: Pain, Dementia, Mild, Dementia, Moderate. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Caregiver-assisted Pain Coping Skills Training for Dementia Pilot Study
Overview
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.
Interventions
- Behavioral Caregiver-Assisted Pain Coping Skills Training (CG-PCST)
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 th
Primary outcome measures
- Client Satisfaction Questionnaire [Time frame: Post-intervention (approximately 8 weeks)]
Secondary outcome measures (8)
- Quality of life in Alzheimer's Disease Caregiver version and Patient version [Time frame: Baseline and post-intervention (approximately 8 weeks)]
- Brief Pain Inventory-Interference Items [Time frame: Baseline and post-intervention (approximately 8 weeks)]
- Caregiver Self-Efficacy in Pain Management [Time frame: Baseline and post-intervention (approximately 8 weeks)]
- Numeric pain scale & verbal descriptor [Time frame: Baseline and post-intervention (approximately 8 weeks)]
- Checklist of nonverbal pain indicators [Time frame: Baseline and post-intervention (approximately 8 weeks)]
- Zarit burden interview [Time frame: Baseline and post-intervention (approximately 8 weeks)]
- Caregiver appraisal-satisfaction scale [Time frame: Baseline and post-intervention (approximately 8 weeks)]
- Neuropsychiatric inventory [Time frame: Baseline and post-intervention (approximately 8 weeks)]
Eligibility criteria
Inclusion criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Duke University Medical Center — Durham
Identifiers
NCT: NCT06854718 · Pro00116129 · 1R61AG088938-01