Trial results for the "Care of Persons With Dementia in Their Environments" (COPE) in Programs of All-Inclusive Care of the Elderly (PACE) study were posted on ClinicalTrials.gov on 2025-06-26, involving 85 participants.
Background
Dementia, encompassing conditions such as Alzheimer's Disease, Frontotemporal Dementia, Multi-Infarct Dementia, Vascular Dementia, and Mixed Dementia, presents significant challenges for patients and their caregivers. The "Care of Persons with Dementia in their Environments" (COPE) program is an evidence-based bio-behavioral intervention designed to support individuals with dementia. Integrating such programs into existing long-term care community-based organizations, like Programs of All-Inclusive Care of the Elderly (PACE), is crucial for improving the quality of life for persons with dementia and their caregivers. This study aimed to evaluate the implementation of the COPE program within PACE settings, focusing on clinician training methods and their impact on both clinician behavior and caregiver outcomes.
Trial design
This completed study, designated as Phase NA, enrolled 85 participants. The trial investigated the implementation of the COPE program within PACE organizations for conditions including Frontotemporal Dementia, Dementia, Multi-Infarct Dementia, Vascular Dementia, and Mixed Dementia. The study involved developing an online training program for COPE and an automated approach to fidelity monitoring. Ten PACE organizations were randomized into two groups, with five serving as control sites. The intervention involved training clinicians as either "Instructor-trained COPE Clinicians" or "COPE Module-trained Clinicians" to deliver the COPE program.
Key results
The trial reported several key measurements related to clinician implementation behavior and caregiver outcomes:
- Determinants of Implementation Behavior Questionnaire (Clinicians) (score on a scale):
- For Instructor-trained COPE Clinicians, a mean score of 0.06 (Standard Deviation 0.53) was observed.
- For COPE Module-trained Clinicians, a mean score of -0.25 (Standard Deviation 0.76) was observed.
- Another measurement for Instructor-trained COPE Clinicians showed a mean score of 0.33 (Standard Deviation 0.87).
- For COPE Module-trained Clinicians, another mean score was 0.06 (Standard Deviation 0.78).
- Perceived Change for Better Index (Caregivers) (score on a scale):
- Caregivers receiving COPE from Instructor-trained COPE Clinicians had a mean score of 9.71 (Standard Deviation 8.65).
- Caregivers receiving COPE from Module-trained COPE Clinicians had a mean score of 4.43 (Standard Deviation 4.50).
- Target Behaviors (Caregivers) (score on a scale):
- Caregivers receiving COPE from Instructor-trained COPE Clinicians showed a mean score of -0.33 (Standard Deviation 0.82).
- Caregivers receiving COPE from Module-trained COPE Clinicians showed a mean score of 1.43 (Standard Deviation 0.79).
- Another measurement for Caregivers receiving COPE from Instructor-trained COPE Clinicians showed a mean score of 0.67 (Standard Deviation 1.63).
- For Caregivers receiving COPE from Module-trained COPE Clinicians, another mean score was 1.00 (Standard Deviation 1.29).
- A further measurement for Caregivers receiving COPE from Instructor-trained COPE Clinicians showed a mean score of 0.60 (Standard Deviation 1.52).
- For Caregivers receiving COPE from Module-trained COPE Clinicians, a final mean score was 0.29 (Standard Deviation 1.11).
What this means
The posted results provide detailed measurements on the implementation of the COPE program within PACE settings, comparing outcomes between instructor-trained and module-trained clinicians, and their impact on caregivers. The data indicates varying mean scores and standard deviations across different outcome measures for both clinician implementation behaviors and caregiver perceived changes and target behaviors. For instance, caregivers receiving COPE from instructor-trained clinicians reported a higher mean score on the "Perceived Change for Better Index" compared to those receiving COPE from module-trained clinicians. These findings offer insights into the effectiveness of different training modalities for COPE delivery and their subsequent influence on caregiver experiences, which can inform future strategies for disseminating evidence-based dementia care programs.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04165213, titled "Care of Persons With Dementia in Their Environments (COPE) in Programs of All-Inclusive Care of the Elderly (PACE)", were posted on 2025-06-26 on clinicaltrials.gov.