Trial Outcomes & Findings for Care of Persons With Dementia in Their Environments (COPE) in Programs of All-Inclusive Care of the Elderly (PACE) (NCT NCT04165213)
NCT ID: NCT04165213
Last Updated: 2025-06-26
Results Overview
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.
COMPLETED
NA
85 participants
Post-training baseline, 14 months
2025-06-26
Participant Flow
Once at least 10 PACE sites agreed to participate, each site was randomized to the control or intervention groups. Clinicians were enrolled and received the type of training that had already been assigned to their site. Intervention = online module training. Control = Instructor-led training. After training, clinicians and staff enrolled dyads (PLWDs \& CGs) to receive COPE. Dyads are assigned to the study arm according to which training their clinician received.
Prior to assignment, the study team worked with Trinity Health PACE to ensure at least 10 PACE sites would enroll in the study.
Unit of analysis: sites
Participant milestones
| Measure |
Traditional Training
These sites were randomized to the control group. Clinicians at these sites received the traditional instructor-led training in the COPE program before delivering to dyads enrolled at their sites.
|
Module Training
These sites were randomized to the intervention group. Clinicians at these sites received the new module training in the COPE program before delivering to dyads enrolled at their sites.
|
|---|---|---|
|
Clinician Enrollment
STARTED
|
15 7
|
12 4
|
|
Clinician Enrollment
Clinician Training Complete
|
12 7
|
12 4
|
|
Clinician Enrollment
Post-training Surveys Complete
|
12 7
|
12 4
|
|
Clinician Enrollment
COPE Delivery Complete
|
8 5
|
9 4
|
|
Clinician Enrollment
COMPLETED
|
8 5
|
9 4
|
|
Clinician Enrollment
NOT COMPLETED
|
7 2
|
3 0
|
|
Caregiver Enrollment
STARTED
|
12 7
|
17 4
|
|
Caregiver Enrollment
Baseline Measures Collected.
|
10 5
|
12 4
|
|
Caregiver Enrollment
Minimal Dose of COPE (4 Sessions) Received.
|
9 5
|
8 4
|
|
Caregiver Enrollment
COMPLETED
|
7 5
|
7 4
|
|
Caregiver Enrollment
NOT COMPLETED
|
5 2
|
10 0
|
|
PLWD Enrollment
STARTED
|
12 7
|
17 4
|
|
PLWD Enrollment
Baseline Measures Collected.
|
10 5
|
12 4
|
|
PLWD Enrollment
Minimal Dose of COPE (4 Sessions) Received.
|
9 5
|
8 4
|
|
PLWD Enrollment
COMPLETED
|
7 5
|
7 4
|
|
PLWD Enrollment
NOT COMPLETED
|
5 2
|
10 0
|
Reasons for withdrawal
| Measure |
Traditional Training
These sites were randomized to the control group. Clinicians at these sites received the traditional instructor-led training in the COPE program before delivering to dyads enrolled at their sites.
|
Module Training
These sites were randomized to the intervention group. Clinicians at these sites received the new module training in the COPE program before delivering to dyads enrolled at their sites.
|
|---|---|---|
|
Clinician Enrollment
Did not deliver COPE to dyads
|
1
|
2
|
|
Clinician Enrollment
Withdrawal by Subject
|
6
|
0
|
|
Clinician Enrollment
Termination from site
|
0
|
1
|
|
Caregiver Enrollment
Withdrawal by Subject
|
0
|
5
|
|
Caregiver Enrollment
Lost to Follow-up
|
1
|
1
|
|
Caregiver Enrollment
Physician Decision
|
1
|
0
|
|
Caregiver Enrollment
PLWD entered long term care, no longer eligible
|
1
|
0
|
|
Caregiver Enrollment
PLWD death
|
2
|
0
|
|
Caregiver Enrollment
Did not receive minimal dose of COPE
|
0
|
4
|
|
PLWD Enrollment
Withdrawal by Subject
|
0
|
5
|
|
PLWD Enrollment
Lost to Follow-up
|
1
|
1
|
|
PLWD Enrollment
Physician Decision
|
1
|
0
|
|
PLWD Enrollment
Entered long term care, no longer eligible
|
1
|
0
|
|
PLWD Enrollment
Death
|
2
|
0
|
|
PLWD Enrollment
Did not receive minimal dose of COPE
|
0
|
4
|
Baseline Characteristics
The age of PLWDS was shared by Trinity Health PACE within a limited data set. The true age of participants aged 89 and older could not be included but only in the category "89 years of age and older."
Baseline characteristics by cohort
| Measure |
Instructor-trained COPE Clinicians
n=12 Participants
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
n=12 Participants
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."
Care of Older Persons in their Environment (COPE) online module training: 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.
|
Caregivers Receiving COPE From Instructor-trained COPE Clinicians
n=10 Participants
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
n=12 Participants
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.
Care of Older Persons in their Environment (COPE) online module training: 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.
|
PLWDs Receiving COPE From Instructor-trained COPE Clinicians
n=10 Participants
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
n=12 Participants
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.
Care of Older Persons in their Environment (COPE) online module training: 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.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Mean Age (Years)
|
44 years
n=12 Participants • The age of PLWDS was shared by Trinity Health PACE within a limited data set. The true age of participants aged 89 and older could not be included but only in the category "89 years of age and older."
|
48 years
n=12 Participants • The age of PLWDS was shared by Trinity Health PACE within a limited data set. The true age of participants aged 89 and older could not be included but only in the category "89 years of age and older."
|
56 years
n=10 Participants • The age of PLWDS was shared by Trinity Health PACE within a limited data set. The true age of participants aged 89 and older could not be included but only in the category "89 years of age and older."
|
63 years
n=12 Participants • The age of PLWDS was shared by Trinity Health PACE within a limited data set. The true age of participants aged 89 and older could not be included but only in the category "89 years of age and older."
|
—
|
—
|
53 years
n=46 Participants • The age of PLWDS was shared by Trinity Health PACE within a limited data set. The true age of participants aged 89 and older could not be included but only in the category "89 years of age and older."
|
|
Age, Customized
60-69 years
|
—
|
—
|
—
|
—
|
1 Participants
n=10 Participants • Clinicians and caregivers mean ages are reported in another measure titles "PLWD age categories."
|
1 Participants
n=12 Participants • Clinicians and caregivers mean ages are reported in another measure titles "PLWD age categories."
|
2 Participants
n=22 Participants • Clinicians and caregivers mean ages are reported in another measure titles "PLWD age categories."
|
|
Age, Customized
70-79 years
|
—
|
—
|
—
|
—
|
4 Participants
n=10 Participants • Clinicians and caregivers mean ages are reported in another measure titles "PLWD age categories."
|
2 Participants
n=12 Participants • Clinicians and caregivers mean ages are reported in another measure titles "PLWD age categories."
|
6 Participants
n=22 Participants • Clinicians and caregivers mean ages are reported in another measure titles "PLWD age categories."
|
|
Age, Customized
80-88 years
|
—
|
—
|
—
|
—
|
4 Participants
n=10 Participants • Clinicians and caregivers mean ages are reported in another measure titles "PLWD age categories."
|
7 Participants
n=12 Participants • Clinicians and caregivers mean ages are reported in another measure titles "PLWD age categories."
|
11 Participants
n=22 Participants • Clinicians and caregivers mean ages are reported in another measure titles "PLWD age categories."
|
|
Age, Customized
89 years and older
|
—
|
—
|
—
|
—
|
1 Participants
n=10 Participants • Clinicians and caregivers mean ages are reported in another measure titles "PLWD age categories."
|
2 Participants
n=12 Participants • Clinicians and caregivers mean ages are reported in another measure titles "PLWD age categories."
|
3 Participants
n=22 Participants • Clinicians and caregivers mean ages are reported in another measure titles "PLWD age categories."
|
|
Sex: Female, Male
Female
|
11 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=12 Participants
|
7 Participants
n=10 Participants
|
6 Participants
n=12 Participants
|
57 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=12 Participants
|
11 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
6 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
8 Participants
n=10 Participants
|
11 Participants
n=12 Participants
|
8 Participants
n=10 Participants
|
10 Participants
n=12 Participants
|
61 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=12 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=12 Participants
|
21 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=12 Participants
|
10 Participants
n=12 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=12 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=12 Participants
|
40 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
6 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: Post-training baseline, 14 monthsPopulation: These outcome measures were collected from clinicians in the control and intervention study arms at post-training baseline (just after training) and follow-up (after implementing COPE to dyads). The means reported are change scores between those timepoints.
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.
Outcome measures
| Measure |
Instructor-trained COPE Clinicians
n=9 Participants
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
n=8 Participants
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."
Care of Older Persons in their Environment (COPE) online module training: 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.
|
|---|---|---|
|
Determinants of Implementation Behavior Questionnaire (Clinicians)
Domain 1 (knowledge) change score
|
0.06 score on a scale
Standard Deviation 0.53
|
-0.25 score on a scale
Standard Deviation 0.76
|
|
Determinants of Implementation Behavior Questionnaire (Clinicians)
Domain 2 (skills) change score
|
0.33 score on a scale
Standard Deviation 0.87
|
0.06 score on a scale
Standard Deviation 0.78
|
PRIMARY outcome
Timeframe: Baseline, 4 monthsPopulation: The means reported indicate the change from baseline to follow up. A positive value indicates an improved perception of well being and better outcome.
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.
Outcome measures
| Measure |
Instructor-trained COPE Clinicians
n=7 Participants
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
n=7 Participants
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."
Care of Older Persons in their Environment (COPE) online module training: 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.
|
|---|---|---|
|
Perceived Change for Better Index (Caregivers)
|
9.71 score on a scale
Standard Deviation 8.65
|
4.43 score on a scale
Standard Deviation 4.50
|
PRIMARY outcome
Timeframe: Baseline, 4 monthsPopulation: 1 caregiver in the control group refused to complete the assessment.
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.
Outcome measures
| Measure |
Instructor-trained COPE Clinicians
n=6 Participants
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
n=7 Participants
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."
Care of Older Persons in their Environment (COPE) online module training: 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.
|
|---|---|---|
|
Target Behaviors (Caregivers)
PLWD behavior ranked #1 in upset level by Caregiver
|
-0.33 score on a scale
Standard Deviation 0.82
|
1.43 score on a scale
Standard Deviation 0.79
|
|
Target Behaviors (Caregivers)
PLWD behavior ranked #2 in upset level by Caregiver
|
0.67 score on a scale
Standard Deviation 1.63
|
1.00 score on a scale
Standard Deviation 1.29
|
|
Target Behaviors (Caregivers)
PLWD behavior ranked #3 in upset level by Caregiver
|
0.60 score on a scale
Standard Deviation 1.52
|
0.29 score on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: BaselinePresence of 12 neuropsychiatric symptoms related to dementia. Caregivers answer yes or no to behaviors exhibited by the PLWD in the month prior to enrollment.
Outcome measures
| Measure |
Instructor-trained COPE Clinicians
n=7 Participants
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
n=7 Participants
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."
Care of Older Persons in their Environment (COPE) online module training: 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.
|
|---|---|---|
|
Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)
Delusions
|
3 Participants
|
4 Participants
|
|
Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)
Hallucinations
|
2 Participants
|
3 Participants
|
|
Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)
Agitation/Aggression
|
5 Participants
|
6 Participants
|
|
Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)
Depression
|
3 Participants
|
5 Participants
|
|
Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)
Anxiety
|
6 Participants
|
6 Participants
|
|
Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)
Elation/Europhia
|
3 Participants
|
0 Participants
|
|
Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)
Apathy/Indifference
|
4 Participants
|
6 Participants
|
|
Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)
Disinhibition
|
3 Participants
|
4 Participants
|
|
Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)
Irritability/Lability
|
6 Participants
|
6 Participants
|
|
Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)
Motor Disturbance
|
3 Participants
|
3 Participants
|
|
Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)
Nighttime behaviors
|
5 Participants
|
7 Participants
|
|
Neuropsychiatric Inventory Brief Questionnaire (NPI-Q) (PLWDs)
Appetite Change
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Caregivers report IADL and ADL support for PLWDs and their upset and confidence in providing support.
Caregivers report instrumental activities of daily living (IADLs) and activities of daily living (ADLs) support for PLWDs and their upset and confidence in providing support. CG chooses up to 16 IADLs/ADLs for which they provide support for the PLWD. Then, the CG rates their own upset level 0 (not upset) to 10 (extremely upset) and confidence level from 0 (not confident at all) to 10 (extremely confident) for each IADL/ADL. Upset and confidence scores are sums of 16 items rated 0-10 on Likert scale. Higher numbers for upset are negative and higher numbers for confidence are positive.
Outcome measures
| Measure |
Instructor-trained COPE Clinicians
n=7 Participants
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
n=7 Participants
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."
Care of Older Persons in their Environment (COPE) online module training: 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.
|
|---|---|---|
|
Caregiver Assessment of Function and Upset Function (CAFU) (Caregivers)
Report of ADL/IADLs
|
8.00 score on a scale
Standard Deviation 3.37
|
10.57 score on a scale
Standard Deviation 2.88
|
|
Caregiver Assessment of Function and Upset Function (CAFU) (Caregivers)
Level of CG confidence for ADL/IADLs support (sum across 16 items on Likert scale 0-10)
|
77.50 score on a scale
Standard Deviation 32.17
|
100.7 score on a scale
Standard Deviation 37.18
|
|
Caregiver Assessment of Function and Upset Function (CAFU) (Caregivers)
Level of CG upset for ADL/IADLs support (sum across 16 items on Likert scale 0-10)
|
22.57 score on a scale
Standard Deviation 8.38
|
22.43 score on a scale
Standard Deviation 9.98
|
SECONDARY outcome
Timeframe: Baseline, 4 monthsThe Zarit Burden Scale (Short 12-items) measures caregiver burden via 12 items assessed via the caregiver as (0 = never, 5 = nearly always). Total scores range from 0 to 48 and indicate no to mild burden (0-10), mild to moderate burden (10-20) and high burden (\> 20).
Outcome measures
| Measure |
Instructor-trained COPE Clinicians
n=7 Participants
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
n=7 Participants
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."
Care of Older Persons in their Environment (COPE) online module training: 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.
|
|---|---|---|
|
Zarit Burden Scale
|
16.71 score on a scale
Standard Deviation 6.32
|
20.86 score on a scale
Standard Deviation 11.68
|
SECONDARY outcome
Timeframe: Baseline, 4 monthsPopulation: Participant data is missing for 1 caregiver in the control group as this participant refused to complete this measure at baseline.
The 7-item SSCQ assesses CG sense of capability and confidence in providing assistance to relatives. Respondents respond to statements about being a caregiver on a 5-point Likert-type scale (1 = strongly agree, 2 = agree, 3 = neither agree not disagree, 4 = disagree, 5 = strongly disagree). Total scores at one time point range from 7-35. The SSCQ has demonstrated reliability (α=.76), content validity via expert consensus panel, and construct validity (r=.88).
Outcome measures
| Measure |
Instructor-trained COPE Clinicians
n=6 Participants
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
n=7 Participants
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."
Care of Older Persons in their Environment (COPE) online module training: 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.
|
|---|---|---|
|
Short Sense of Competence Questionnaire (SSCQ) (Caregivers)
|
-0.17 score on a scale
Standard Deviation 5.19
|
2.43 score on a scale
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: Baseline, 4 monthsCaregivers complete this 13-item questionnaire as proxies to measure the quality of life of the person living with dementia (PLWD). Points are assigned to each item (poor = 1, fair = 2, good = 3, excellent = 4). The total score is the sum of all 13 items that generates summary scales for physical components (PCS) and for mental health components (MCS). Total scores range from 13-52.
Outcome measures
| Measure |
Instructor-trained COPE Clinicians
n=7 Participants
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
n=7 Participants
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."
Care of Older Persons in their Environment (COPE) online module training: 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.
|
|---|---|---|
|
Quality of Life in Alzheimer's Disease (QOL-AD) (PLWDs)
|
-1.71 score on a scale
Standard Deviation 4.92
|
-0.43 score on a scale
Standard Deviation 4.69
|
SECONDARY outcome
Timeframe: BaselinePopulation: One caregiver in the control group refused to answer this baseline measure.
Self-report measure of social engagement including family and friends via 12 items. Items assess how many people participant sees at different time periods (0 = none, 5 = nine of more) and how often participant has social interactions (0 = less than monthly, 5 = daily). Total scores range from 0 - 60.
Outcome measures
| Measure |
Instructor-trained COPE Clinicians
n=6 Participants
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
n=7 Participants
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."
Care of Older Persons in their Environment (COPE) online module training: 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.
|
|---|---|---|
|
Lubben Social Network Scale (LSNS) (Caregivers)
|
35.33 score on a scale
Standard Deviation 7.81
|
35.14 score on a scale
Standard Deviation 3.44
|
Adverse Events
Instructor-trained COPE Clinicians
COPE Module-trained Clinicians
Caregivers Receiving COPE From Instructor-trained COPE Clinicians
Caregivers Receiving COPE From Module-trained COPE Clinicians
PLWDs Receiving COPE From Instructor-trained COPE Clinicians
PLWDs Receiving COPE From Module-trained COPE Clinicians
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Emily Summerhayes, Project Manager
University of Pennsylvania, School of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place