Care of Persons With Dementia in Their Environments (COPE) in Programs of All-Inclusive Care of the Elderly (PACE)

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT04165213
Status
Completed

Conditions

  • Alzheimer Disease
  • Dementia
  • Frontotemporal Dementia
  • Lewy Body Disease
  • Mixed Dementia
  • Multi-Infarct Dementia
  • Neurocognitive Disorders
  • Pick Disease
  • Vascular Dementia

Eligibility Criteria

Sex
ALL
Age
21 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Care of Older Persons in their Environment (COPE) online module training — BEHAVIORAL
    An online module version of training for clinicians (OTs and RNs) in the evidence-based dementia caregiving program called Care of Older Persons in their Environment (COPE) is the intervention being tested for non-inferiority against the usual instructor-led COPE training. COPE modules include rich multimedia content, simulated scenarios, interactive assessments to keep the learner engaged The content is packaged into the latest the latest Shareable Content Object Reference Model (SCORM) specifications, which will allow for repurposing and sharing with other institutions. Each of the ten modules last 45-60 minutes.

Study Details

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.

Key Dates

Start date
Jun 28, 2021
Status verified
Jun 2025
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

Enrollment
85 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Instructor-trained COPE clinicians
    Clinicians from PACE sites randomized to this study arm (control) will receive instructor-led training in the evidence-based dementia care program called COPE. After clinician consent and enrollment, outcome measures will be collected prior to training (pre-training baseline), after training (post-training baseline), and after delivering COPE to dyads (4 months post-implementation). Dyads (caregivers and PLWDs) receiving COPE from Instructor-trained COPE clinicians are represented in the study arms "Caregivers receiving COPE from instructor-trained COPE clinicians" and "PLWDs COPE from instructor-trained COPE clinicians." These participants are receiving the usual instructor-led training - not the experimental training.
  • Experimental: COPE module-trained clinicians
    Clinicians from PACE sites randomized to this study arm (intervention) will receive self-paced online module training in the evidence-based dementia care program called COPE. After clinician consent and enrollment, outcome measures will be collected prior to training (pre-training baseline), after training (post-training baseline), and after delivering COPE to dyads (4 months post-implementation). Dyads (caregivers and PLWDs) receiving COPE from module-trained COPE clinicians are represented in the study arms "Caregivers receiving COPE from module-trained COPE clinicians" and "PLWDs COPE from module-trained COPE clinicians."
  • No Intervention: Caregivers receiving COPE from instructor-trained COPE clinicians
    Caregivers of eligible PLWDS enrolled at PACE sites randomized to the control arm will be recruited by "instructor-trained COPE clinicians." After initial recruitment, the study team will carry out consent and screening procedures with caregivers and collect caregiver outcome data at baseline (before meeting with COPE clinicians) and follow-up (4 months post-implementation). Caregivers must complete a minimal dose of 4 sessions out of 10 to be included in follow-up measures. Outcomes will be reviewed for change from baseline to follow-up and compared to "caregivers receiving COPE from module-trained COPE clinicians" for non-inferiority. These participants are receiving COPE from clinicians trained in the instructor-led COPE training.
  • Experimental: Caregivers receiving COPE from module-trained COPE clinicians
    Primary caregivers of eligible PLWDS enrolled at PACE sites randomized to the intervention arm will be recruited by "module-trained COPE clinicians." After initial recruitment, the study team will carry out consent and screening procedures with caregivers and collect caregiver outcome data at baseline (before meeting with COPE clinicians) and follow-up (4 months post-implementation). Caregivers must complete a minimal dose of 4 sessions out of 10 to be included in follow-up measures. Outcomes will be reviewed for change from baseline to follow-up and compared to "caregivers receiving COPE from instructor-trained COPE clinicians" for non-inferiority.
  • No Intervention: PLWDs receiving COPE from instructor-trained COPE clinicians
    Eligible PLWDS enrolled at PACE sites randomized to the control arm will be screened for eligibility and initial interest by "instructor-trained COPE clinicians" before caregiver recruitment. PLWDs will only be enrolled if caregivers consent to participate. PLWD outcome data will be collected at baseline (before meeting with COPE clinicians) and follow-up (4 months post-implementation). A minimal dose of 4 sessions out of 10 sessions must be completed for PLWD to be included in follow-up measures. Outcomes will be reviewed for change from baseline to follow-up and compared to "PLWDS receiving COPE from module-trained COPE clinicians" for non-inferiority. These participants are receiving COPE from clinicians trained in the usual instructor-led COPE training.
  • Experimental: PLWDs receiving COPE from module-trained COPE clinicians
    Eligible PLWDS enrolled at PACE sites randomized to the intervention arm will be screened for eligibility and initial interest by "module-trained COPE clinicians" before caregiver recruitment. PLWDs will only be enrolled if caregivers consent to participate. PLWD outcome data will be collected at baseline (before meeting with COPE clinicians) and follow-up (4 months post-implementation). A minimal dose of 4 sessions out of 10 sessions must be completed for PLWD to be included in follow-up measures. Outcomes will be reviewed for change from baseline to follow-up and compared to "PLWDS receiving COPE from instructor-trained COPE clinicians" for non-inferiority.

Primary Outcome Measure

Determinants of Implementation Behavior Questionnaire (Clinicians) [ Time Frame: Post-training baseline, 14 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-4217-

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By research site
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