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NCT04165213 · ClinicalTrials.gov registry record · NA
Care of Persons With Dementia in Their Environments (COPE) in Programs of All-Inclusive Care of the Elderly (PACE)
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 85
- Enrollment target
NCT04165213: Completed NA study, sponsored by University of Pennsylvania.
NCT04165213 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 85 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04165213, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 85 participants
- Enrollment target
Study Summary
The protocol is organized into three Phases - In Phase I an online training program will be developed in "Care of Persons with Dementia in their Environments" (COPE) -an evidence-based bio-behavioral dementia program -using state-of-the science simulation and best online learning practices. In addition an automated approach to fidelity monitoring using computational linguistics (automatic classification programs) will be developed. In Phase II, ten long term care community-based (PACE) organizations will be randomized into two groups; 5 PACE organizations will serve as the "control" site in which staff training will be provided via the traditional high intensity face-to-face training in the COPE program. 5 PACE organizations will serve as the comparison and staff will be trained using the online COPE training program. Phase II will evaluate the whether an online training program is the same or better in improving PACE staff competency and fidelity to COPE principles and protocols compared to a high intensity face-to-face traditional form of training. In Phase III the efficacy of the COPE program on PACE participant outcomes by type of COPE training will be evaluated. Each of the PACE organizations will enroll 5 persons with dementia and their caregivers in the study. This will yield 50 family dyads (25 dyads in traditional training sites and 25 dyads in online training sites). Dyads will be followed for 4 months. Non-inferiority analysis will be used to assess whether dyads will yield the same or better outcomes regardless of how PACE staff were trained.
Primary Outcome
The Determinants of Implementation Behavior Questionnaire (DIBQ) contains 93 items assessing 18 domains and is used to identify determinants of implementation behaviors in order to be able to develop effective strategies to improve healthcare professionals' implementation behaviors. Clinicians in this study were assessed for implementation behavior at post training baseline (prior to COPE implementation) and at follow up (post-implementation) for two DIBQ domains, "knowledge" and "skills." These
Interventions
- BEHAVIORAL Care of Older Persons in their Environment (COPE) online module training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2024-05-31 |
| Phase | NA |
What the finished NCT04165213 record still lists
NCT04165213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Care of Older Persons in their Environment (COPE) online module training is the first listed.
NCT04165213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04165213 about?
NCT04165213 is a clinical study titled "Care of Persons With Dementia in Their Environments (COPE) in Programs of All-Inclusive Care of the Elderly (PACE)". The protocol is organized into three Phases - In Phase I an online training program will be developed in "Care of Persons with Dementia in their Environments" (COPE) -an evidence-based bio-behavioral dementia program -using state-of-the science simulation and best online learning practices. In addit...
What is the current status of trial NCT04165213?
This trial is currently completed. It is a NA study. The enrollment target is 85 participants. The study started on 2021-06-28. Estimated completion is 2024-05-31.
What interventions are being tested in trial NCT04165213?
The interventions under investigation include: Care of Older Persons in their Environment (COPE) online module training (BEHAVIORAL).
Who is sponsoring clinical trial NCT04165213?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04165213's enrollment target sits among peer trials
85 980th of 2000 higher than 1,018 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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