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

NCT04165213 | Completed Results DMC

• 1 other identifier: 831688
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Determinants of Implementation Behavior Questionnaire (Clinicians)

  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 two domains have demonstrated good discriminant validity and are highly correlated in recent studies (https://doi.org/10.1186/1748-5908-9-33). Participants answer each item with a response from 1 (strongly disagree agree) to 5 (strongly agree) with an option to refuse to respond (score of 0). Each domain has a minimum total score of 0 and maximum total score of 10. Higher scores are positive and indicate improved knowledge and skills in COPE.

  Post-training baseline, 14 months

• Perceived Change for Better Index (Caregivers)

  The Perceived Change for Better Index is a 13-item scale that measures caregiver appraisals of self-improvement or decline in areas of well-being within a month of survey completion. Caregivers rate items on a 5-point Likert-type scale (1 = became much worse, 2 = became somewhat worse, 3 = stayed the same, 4 = improved somewhat, 5 = improved a lot). Total scores at one time point range from 13-65. Higher scores indicate better outcomes.

  Baseline, 4 months

• Target Behaviors (Caregivers)

  This measure captures the top 3 dementia behaviors exhibited by the PLWD and chosen by the caregiver to work on in the COPE program. At baseline, the caregiver selects and ranks the top 3 behaviors (assessed via the Neuropsychiatric Inventory brief questionnaire) and/or activities (assessed via the Caregiver Assessment of Function and Upset Function) and rates confidence levels (0 = not at all, 4 = extremely). Caregivers reassess confidence levels at the 4-month follow up. The means reported are the change scores from baseline to follow up. A positive value indicates greater confidence and a better outcome.

  Baseline, 4 months

Secondary Outcomes (6)

• Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)

  Baseline

• Caregiver Assessment of Function and Upset Function (CAFU) (Caregivers)

  Baseline

• Zarit Burden Scale

  Baseline, 4 months

• Short Sense of Competence Questionnaire (SSCQ) (Caregivers)

  Baseline, 4 months

• Quality of Life in Alzheimer's Disease (QOL-AD) (PLWDs)

  Baseline, 4 months

Study Arms (6)

Instructor-trained COPE clinicians

NO INTERVENTION

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.

COPE module-trained clinicians

EXPERIMENTAL

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."

Behavioral: Care of Older Persons in their Environment (COPE) online module training

Caregivers receiving COPE from instructor-trained COPE clinicians

NO INTERVENTION

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.

Caregivers receiving COPE from module-trained COPE clinicians

EXPERIMENTAL

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.

Behavioral: Care of Older Persons in their Environment (COPE) online module training

PLWDs receiving COPE from instructor-trained COPE clinicians

NO INTERVENTION

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.

PLWDs receiving COPE from module-trained COPE clinicians

EXPERIMENTAL

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.

Behavioral: Care of Older Persons in their Environment (COPE) online module training

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.

Also known as: COPE online training

COPE module-trained clinicians; Caregivers receiving COPE from module-trained COPE clinicians; PLWDs receiving COPE from module-trained COPE clinicians

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Drexel University: collaborator
• Thomas Jefferson University: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4217, United States

Location

Related Publications (1)

• Hodgson NA, McPhillips MV, Hirschman KB, Summerhayes E, Piersol CV, Gitlin LN. Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocol. Contemp Clin Trials Commun. 2025 Apr 5;45:101478. doi: 10.1016/j.conctc.2025.101478. eCollection 2025 Jun.

  PMID: 40248174 DERIVED

MeSH Terms

Conditions

Frontotemporal Dementia; Dementia; Dementia, Multi-Infarct; Dementia, Vascular; Mixed Dementias; Alzheimer Disease; Lewy Body Disease; Pick Disease of the Brain; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Mental Disorders; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Tauopathies; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Results Point of Contact

• Title: Emily Summerhayes, Project Manager
• Organization: University of Pennsylvania, School of Nursing

esummer@nursing.upenn.edu

6099233786

Study Officials

• Nancy A Hodgson, PhD RN FAAN

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: November 15, 2019
• Study Start: June 28, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: May 2025
• Access Criteria: NIH Manuscript Submission System

Locations

US (1)