N/A
Completed N=27
Care of Persons With Dementia in Their Environments (COPE) in Programs of All-Inclusive Care of the Elderly (PACE)
Source: ClinicalTrials.gov NCT04165213 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Determinants of Implementation Behavior Questionnaire (Clinicians) — 0.06; -0.25; 0.33; 0.06 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determinants of Implementation Behavior Questionnaire (Clinicians) |
0.06; -0.25; 0.33; 0.06 | — |
| PRIMARY Perceived Change for Better Index (Caregivers) |
9.71; 4.43 | — |
| PRIMARY Target Behaviors (Caregivers) |
-0.33; 1.43; 0.67; 1.00; 0.60; 0.29 | — |
| SECONDARY Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs) |
3; 4; 2; 3; 5; 6 | — |
| SECONDARY Caregiver Assessment of Function and Upset Function (CAFU) (Caregivers) |
8.00; 10.57; 77.50; 100.7; 22.57; 22.43 | — |
| SECONDARY Zarit Burden Scale |
16.71; 20.86 | — |
| SECONDARY Short Sense of Competence Questionnaire (SSCQ) (Caregivers) |
-0.17; 2.43 | — |
| SECONDARY Quality of Life in Alzheimer's Disease (QOL-AD) (PLWDs) |
-1.71; -0.43 | — |
| SECONDARY Lubben Social Network Scale (LSNS) (Caregivers) |
35.33; 35.14 | — |
Eligibility Criteria
Inclusion Criteria
- Our inclusion criteria are purposively broad to reflect the real world case mix of PACE staff, persons living with dementia and their caregivers using PACE programs. Inclusion Criteria: PACE organization staff will be eligible if they are Occupational Therapists (OTs) or Registered Nurses (RNs) employed full time for more than 1 year at the enrolled PACE site and in good standing . Persons with dementia will be eligible if they: a) are a Trinity PACE participant; b) have a diagnosis of dementia or = four errors on the Mental Status Questionnaire (MSQ, 39), which is updated for each PACE participant every 6 months; (The MSQ threshold of = 4 errors is considered moderate cognitive impairment); c) speaks or understands English. Caregivers are eligible to participate if they: a) have primary responsibility for care of the person with dementia (defined as being the responsible party who enrolled the participant in PACE and who provides hands-on or supervisory assistance with one or more instrumental or daily activities of living); b) speak English; c) have a telephone and are willing to participate in 3 telephone interviews (baseline, 4-and 9 month follow-ups); and d) are 21 years of age or older (male or female). While more than one family member may provide care to the person with dementia and participate in the COPE sessions, we will enroll the family member designated as the responsible party for the purpose of evaluating treatment effects.s in online training sites). At 4 months, study outcomes will be assessed.
Exclusion Criteria
- Persons with dementia will be excluded if they are a) Diagnosed with schizophrenia or bipolar disorder; b) bedbound and unresponsive; c) participating in a concurrent experimental drug study designed to treat agitation or aggressive behaviors. Dyads are not eligible if: a) they plan to move from the area within 9 months, b) either has been hospitalized >3 times in past year; c) either is in active treatment for a terminal illness or are in hospice; and d) caregiver is involved in other support services/trials. These criteria are designed to minimize attrition and exclude caregivers of relatives at high mortality risk who may not benefit from the COPE Program.
Dyads (PLWDS and CGs) will be excluded from the final sample if they do not complete at least 4 COPE sessions.
Data sourced from ClinicalTrials.gov (NCT04165213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.