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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61AG088938-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institutes of Health (NIH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-Caregiver Dyads | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caregiver-Assisted Pain Coping Skills Training (CG-PCST) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Client Satisfaction Questionnaire | Caregiver completes. Score range: 1-4; higher score indicates better outcome | Post-intervention (approximately 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and post-intervention (approximately 8 weeks) |
| Brief Pain Inventory-Interference Items |
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Inclusion Criteria:
Patients:
Caregivers:
Exclusion Criteria:
Patient and caregivers
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Porter, Ph.D | Contact | 919-416-3436 | Laura.Porter@duke.edu | |
| Katherine Ramos, Ph.D | Contact | 919-416-3434 | Katherine.Ramos@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Laura Porter, Ph.D | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D003704 | Dementia |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
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Patient and Caregiver will complete Patient pain interference. Score range: 0-10; higher score indicates worse outcome |
| Baseline and post-intervention (approximately 8 weeks) |
| Caregiver Self-Efficacy in Pain Management | Caregiver will complete caregiver self-efficacy. Score range: 0-10; higher score indicates better outcome | Baseline and post-intervention (approximately 8 weeks) |
| Numeric pain scale & verbal descriptor | Patient will complete patient pain intensity. Score range: 0-19; higher score indicates worse outcome | Baseline and post-intervention (approximately 8 weeks) |
| Checklist of nonverbal pain indicators | Caregiver will complete patient pain intensity. Score range: 0-10; higher score indicates worse outcome | Baseline and post-intervention (approximately 8 weeks) |
| Zarit burden interview | Caregivers will complete caregiver burden. Score range: 0-88; higher score indicates worse outcome | Baseline and post-intervention (approximately 8 weeks) |
| Caregiver appraisal-satisfaction scale | Caregiver will complete caregiver satisfaction. Score range: 0-10; higher score indicates worse outcome | Baseline and post-intervention (approximately 8 weeks) |
| Neuropsychiatric inventory | Caregiver will complete patient neuropsychiatry behaviors. Score range: 0-144; higher score indicates worse outcome | Baseline and post-intervention (approximately 8 weeks) |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |