Caregiver-Assisted Pain Coping for Dementia

(PWD Trial)

Overseen By Katherine Ramos, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Severe behavioral problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 6-8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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).

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Is Caregiver-Assisted Pain Coping for Dementia safe for humans?

The studies reviewed focus on the feasibility and acceptability of caregiver-assisted interventions for pain management in dementia, but they do not report any specific safety concerns or adverse effects, suggesting that these interventions are generally safe for humans. ^{1 2 3 4 5}

How is the Caregiver-Assisted Pain Coping Skills Training (CG-PCST) treatment different from other treatments for dementia?

The Caregiver-Assisted Pain Coping Skills Training (CG-PCST) is unique because it focuses on equipping caregivers with coping strategies to manage their own stress and anxiety, which can indirectly improve the care they provide to people with dementia. Unlike other treatments that may focus directly on the person with dementia, this approach emphasizes the caregiver's role and their ability to handle stress, potentially reducing caregiver burden and improving the caregiving experience. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Caregiver-Assisted Pain Coping Skills Training (CG-PCST) for dementia?

Research shows that caregivers can effectively assess and manage pain in people with dementia when they receive proper training, as seen in studies where caregivers improved their skills in recognizing and communicating about pain. This suggests that caregiver-assisted interventions like CG-PCST could be beneficial in managing pain for dementia patients. ^{1 2 11 12 13}

Who Is on the Research Team?

Laura Porter, Ph.D

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals aged 50 or older with mild to moderate dementia experiencing daily pain for at least three months that disrupts their daily life. They must live at home, speak English, and have a caregiver who assists them for at least four hours per day. Caregivers must be 18 or older.

Inclusion Criteria

I provide at least 4 hours of care daily to the patient.

I live in my own home, not in a care facility.

I am 50 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patient-caregiver dyads receive five 45-60 minute sessions over a 6-8 week period via videoconference with a masters-level therapist

6-8 weeks

5 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Caregiver-Assisted Pain Coping Skills Training (CG-PCST)

Trial Overview The study aims to test a program where caregivers help patients with dementia develop skills to manage pain better. It involves training sessions designed specifically for patient-caregiver pairs, focusing on coping strategies tailored to the challenges of dementia.

How Is the Trial Designed?

Group I: Patient-Caregiver Dyads Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

The Pain Identification and Communication Toolkit (PICT) was successfully implemented in a pilot trial with family caregivers of 34 individuals with dementia, showing that 100% of participants completed the intervention and 94% completed follow-up assessments.

Caregivers who used PICT reported increased confidence in recognizing (67%) and communicating about pain symptoms (83%), indicating that the toolkit may effectively enhance caregivers' skills in managing pain in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia. Riffin, C., Brody, L., Mukhi, P., et al.[2023]

An educational intervention based on the Progressively Lowered Stress Threshold (PLST) model significantly improved the knowledge and caregiving practices of 38 caregivers for people with dementia over a two-year period in Isfahan, Iran.

The study demonstrated that tailored educational content, considering cultural and religious backgrounds, effectively enhanced caregivers' skills in managing challenging behaviors associated with dementia, as indicated by statistically significant increases in their knowledge and practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of educational intervention based on the Progressively Lowered Stress Threshold extended model on the process of caregiving for people with dementia. Zamani-Alavijeh, F., Zahed, S., Emami, M., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Partnering to cope with pain: A pilot study of a caregiver-assisted pain coping skills intervention for patients with cognitive impairment and dementia. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Pain in community-dwelling persons with dementia: frequency, intensity, and congruence between patient and caregiver report. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Caregiving self-efficacy and pain assessment by family caregivers of people living with dementia. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

People Living With Dementia: Dementia Characteristics and Family Caregiver Pain Assessment. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Developing a Training for Certified Nursing Assistants to Recognize, Communicate, and Document Discomfort in Residents With Dementia. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility of a staff training and support programme to improve pain assessment and management in people with dementia living in care homes. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Immediate and Lagged Effects of Daily Stress and Affect on Caregivers' Daily Pain Experience. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Coping strategies and anxiety in caregivers of people with Alzheimer's disease: the LASER-AD study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness of coping strategies intervention on caregiver burden among caregivers of elderly patients with dementia. [2022]

11. France pubmed.ncbi.nlm.nih.gov

Helping caregivers of people with dementia: a need to renew theoretical frameworks in France. [2019]

12. England pubmed.ncbi.nlm.nih.gov

The effect of educational intervention based on the Progressively Lowered Stress Threshold extended model on the process of caregiving for people with dementia. [2023]

13. Spain pubmed.ncbi.nlm.nih.gov

[Differential efficacy of two psychoeducational interventions for dementia family caregivers]. [2018]