Trial Outcomes & Findings for Outreach-ER: A Dementia Care Intervention Program (NCT NCT05451693)
NCT ID: NCT05451693
Last Updated: 2025-02-05
Results Overview
Number of potential participant/care partner dyads contacted. Higher number indicates higher number of attempts as recruitment.
Recruitment status
TERMINATED
Target enrollment
8 participants
Primary outcome timeframe
4 months
Results posted on
2025-02-05
Participant Flow
4 PLWD 4 Caregivers of PLWD
Participant milestones
| Measure |
Outreach-ER (People Living With Dementia)
Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.
Outreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.
|
Outreach-ER (Caregiver)
Caregiver to the PLWD also participating in the Outreach-ER program.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Outreach-ER (People Living With Dementia)
Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.
Outreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.
|
Outreach-ER (Caregiver)
Caregiver to the PLWD also participating in the Outreach-ER program.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Outreach-ER: A Dementia Care Intervention Program
Baseline characteristics by cohort
| Measure |
Outreach-ER (People Living With Dementia)
n=4 Participants
Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.
Outreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.
|
Outreach-ER (Caregivers of PLWD)
n=4 Participants
Caregivers of PLWD also participating in the Outreach-ER program.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
65 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Dementia Type
Late Onset Alzheimer's Disease
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Dementia Type
Lewy Body Dementia (Mixed)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Dementia Type
Alzheimer's Disease with Down Syndrome
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Dementia Type
No Dementia
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsNumber of potential participant/care partner dyads contacted. Higher number indicates higher number of attempts as recruitment.
Outcome measures
| Measure |
Outreach-ER
n=32 Participants
Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.
Outreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.
|
|---|---|
|
Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER
|
32 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPercentage of participant/care partner dyads who enroll and consent \[range: 0-100%\]. Higher number indicates more feasibility.
Outcome measures
| Measure |
Outreach-ER
n=32 Participants
Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.
Outreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.
|
|---|---|
|
Recruitment Rate for Feasibility and Acceptability of Outreach-ER
|
13 percentage of attempted recruits
|
PRIMARY outcome
Timeframe: First day of interventionPercentage of participant/care partner dyads who start Outreach-ER program \[range: 0-100%\]. Higher number indicates more feasibility.
Outcome measures
| Measure |
Outreach-ER
n=32 Participants
Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.
Outreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.
|
|---|---|
|
Participant Rate for Feasibility and Acceptability of Outreach-ER
|
13 percentage of attempted recruits
|
PRIMARY outcome
Timeframe: about 4 monthsPercentage of participant/care partner dyads who complete intervention (7 or more visits) \[range: 0-100%\]. Higher number indicates more feasibility.
Outcome measures
| Measure |
Outreach-ER
n=4 Participants
Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.
Outreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.
|
|---|---|
|
Completion Rate for Feasibility and Acceptability of Outreach-ER
|
75 percentage of enrolled participants
|
PRIMARY outcome
Timeframe: about 4 monthsPercentage of participant/care partner dyads who complete each intervention visit \[range: 0-100%\]. Number of total intervention visits completed = total completed visits for the 4 dyads. Number of total intervention visits available = 6 visits x 4 dyads = 24 visits. Number of total intervention visits completed/24 total intervention visits x 100 = percentage. Higher number indicates more feasibility.
Outcome measures
| Measure |
Outreach-ER
n=24 sessions
Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.
Outreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.
|
|---|---|
|
Session Specific Completion Rate for Feasibility and Acceptability of Outreach-ER
|
86 percentage of sessions completed
|
PRIMARY outcome
Timeframe: about 4 monthsPercentage of participant/care partner dyads who complete each questionnaire \[range: 0-100%\]. Number of total questionnaires completed = total completed questionnaires for the 4 dyads. Number of total questionnaires available = 3 questionnaires x 4 dyads x 2 visit time points = 24 available questionnaires. Number of total questionnaires completed/24 total questionnaires available x 100 = percentage. Higher number indicates more feasibility.
Outcome measures
| Measure |
Outreach-ER
n=24 questionnaires
Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.
Outreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.
|
|---|---|
|
Questionnaire Specific Response Rate for Feasibility and Acceptability of Outreach-ER
|
67 percentage of completed questionnaires
|
SECONDARY outcome
Timeframe: about 4 monthsPercentage of care partners that respond to all of the items on each scale \[range: 0-100%\]. Higher number indicates more feasibility.
Outcome measures
| Measure |
Outreach-ER
n=4 Participants
Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.
Outreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.
|
|---|---|
|
Completeness of Specific Measures for Feasibility and Acceptability of Outreach-ER
|
75 percentage of completed questions
|
Adverse Events
Outreach-ER (People Living With Dementia)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Outreach-ER (Caregivers of PLWD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place