Care of Persons With Dementia in Their Environments (COPE) in Programs of All-Inclusive Care of the Elderly (PACE)
Frontotemporal Dementia, Dementia, Multi-Infarct Dementia
About this trial
This is an interventional supportive care trial for Frontotemporal Dementia
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.
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Online training site
COPE-PACE participant outcomes with online training
Ten participating Trinity PACE Organizations will participate via webinar in a brief orientation/ training to the study and project logistics. Next, Trinity Health PACE organizations will be randomized into two groups using the re-randomization procedures described in the paragraph below; 5 PACE organizations will serve as the "control" site in which training will be provided via the traditional high intensity face-to-face.; 5 PACE organizations will serve as the comparison and be trained through the online training site. Prior to randomization, we will carefully examine PACE organizations on important variables such as size, location (urban; rural) percent of persons with dementia, and staff: participant ratio. In each site, one occupational therapist (OT) and one nurse (RN) will be trained (e.g., 5 OTs and 5 RNs in traditional sites; 5 OTS and 5 RNS in online training sites for a total of 10 OTs and 10 RNs or 20 health providers).
The efficacy of the COPE program training on PACE participant outcomes by type of COPE training will be evaluated in this arm. Each of the PACE organizations will enroll 5 persons with dementia and their caregivers in the study. This will yield 50 family dyads or 100 subjects (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.