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

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ClinicalTrials.gov Identifier: NCT04165213
Recruitment Status : Not yet recruiting
First Posted : November 15, 2019
Last Update Posted : July 31, 2020
Sponsor:
Collaborators:
Drexel University
Thomas Jefferson University
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Frontotemporal Dementia Dementia Multi-Infarct Dementia Vascular Dementia Mixed Dementia Alzheimer Disease Lewy Body Disease Pick Disease Neurocognitive Disorders Behavioral: COPE online training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Training and Fidelity Model to Move and Scale Evidence-based Dementia Care and Caregiver Support Programs Into Practice: The Case for COPE in PACE Service Settings
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023


Arm Intervention/treatment
Experimental: Online training site
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).
Behavioral: COPE online training

The intervention being tested is PACE staff training in COPE - accomplished with the creation of self-paced online learning modules.

The modules will include rich multimedia content and interactive assessments to keep the learner engaged and will allow for easy packaging of the content into the latest interoperability standards for such content including the latest Shareable Content Object Reference Model (SCORM) specifications, which will allow for repurposing and sharing with other institutions and will be designed using a hyperlearning model with four dimensions. The self-paced modules will be highly interactive featuring integrated multimedia content, assessments, and learner evaluations to allow PACE staff to engage with the content at a high level and practice application in simulated scenarios. Each module will require approximately 45-60 minutes/module for the learner to complete.le for the learner to complete.


Experimental: COPE-PACE participant outcomes with online training
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.
Behavioral: COPE online training

The intervention being tested is PACE staff training in COPE - accomplished with the creation of self-paced online learning modules.

The modules will include rich multimedia content and interactive assessments to keep the learner engaged and will allow for easy packaging of the content into the latest interoperability standards for such content including the latest Shareable Content Object Reference Model (SCORM) specifications, which will allow for repurposing and sharing with other institutions and will be designed using a hyperlearning model with four dimensions. The self-paced modules will be highly interactive featuring integrated multimedia content, assessments, and learner evaluations to allow PACE staff to engage with the content at a high level and practice application in simulated scenarios. Each module will require approximately 45-60 minutes/module for the learner to complete.le for the learner to complete.





Primary Outcome Measures :
  1. Caregiver Assessment to Function and Upset will measure change in functional ability [ Time Frame: 4 months ]
    Caregiver (CG) proxy report of participant's dependence level (a little to complete help) using the Caregiver Assessment fo Function and Upset (CAFU), a 15-item multidimensional measure of dependence in dementia patients and caregiver reaction. The level of assistance is determined using a 7-point response option (7 = complete independence and 1 = total assistance).


Secondary Outcome Measures :
  1. Neuropsychiatric Inventory will measure neuropychiatric symptoms change [ Time Frame: 4 months ]
    Neuropsychiatric Inventory brief questionnaire (NPI-Q). CG rates presence of 12 symptoms in the past month (yes/no), severity from 1-3 (score 0-36); the NPI-Q has an interscale correlation of 0.91 for severity

  2. Perceived Change for Better Index will measure change in caregiver well being [ Time Frame: 4 months ]
    13-item Perceived Change for Better Index assesses perceived change (gotten worse (a little, a lot), stayed the same, or improved (a little or a lot) in 3 areas: affective wellbeing, somatic (fatigue, sleep, overall health), ability to manage day-to-day care). It is sensitive to change and has strong psychometric properties.

  3. Short Sense of Competence Questionnaire will measure change in caregiver skills [ Time Frame: 4 months ]
    The 7-item Short Sense of Competence Questionnaire (SSCQ), will assess CG sense of capability and confidence in providing assistance to relatives. The SSCQ has demonstrated reliability (α=.76), content validity via expert consensus panel, and construct validity (r=.88)

  4. Health Related Quality of Life change [ Time Frame: 4 months ]
    Short Form-36 (SF-36) is a widely used health related QOL and functional ability measure that generates summary scales for physical components (PCS) and for mental health components (MCS). The SF-36 has been shown to be a reliable and valid measure for caregiver ratings of function and QOL in persons with dementia. The scores for the PCS and MCS have been norm-based to a mean of 50 and a standard deviation of 10.



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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04165213    
Other Study ID Numbers: 831688
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Dementia, Vascular
Lewy Body Disease
Dementia, Multi-Infarct
CADASIL
Neurocognitive Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases