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Planned recruitment was not feasible.
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This is a feasibility/pilot, prospective cohort study to determine how to implement and refine Outreach-ER intervention for a larger clinical study. A key feature of Outreach-ER is to reach out to people living with dementia (PLWD) and their families following an emergency room visit or hospitalization. The outcome of this study will help in the overall goal of studying the impact of Outreach-ER in a larger clinical study and focus on outcomes relevant to PLWD and their care partners.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outreach-ER | 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/people living with dementia (PLWD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outreach-ER | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER | Number of potential participant/care partner dyads contacted. Higher number indicates higher number of attempts as recruitment. | 4 months |
| Recruitment Rate for Feasibility and Acceptability of Outreach-ER | Percentage of participant/care partner dyads who enroll and consent [range: 0-100%]. Higher number indicates more feasibility. | 4 months |
| Participant Rate for Feasibility and Acceptability of Outreach-ER | Percentage of participant/care partner dyads who start Outreach-ER program [range: 0-100%]. Higher number indicates more feasibility. | First day of intervention |
| Completion Rate for Feasibility and Acceptability of Outreach-ER | Percentage of participant/care partner dyads who complete intervention (7 or more visits) [range: 0-100%]. Higher number indicates more feasibility. | about 4 months |
| Session Specific Completion Rate for Feasibility and Acceptability of Outreach-ER | Percentage 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. | about 4 months |
| Questionnaire Specific Response Rate for Feasibility and Acceptability of Outreach-ER |
| Measure | Description | Time Frame |
|---|---|---|
| Completeness of Specific Measures for Feasibility and Acceptability of Outreach-ER | Percentage of care partners that respond to all of the items on each scale [range: 0-100%]. Higher number indicates more feasibility. | about 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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Population includes people living with dementia (PLWD) who are treated at the Regions Hospital Emergency Department in Saint Paul, MN.
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| Name | Affiliation | Role |
|---|---|---|
| Bhavani Kashyap, MBBS, PhD | HealthPartners Neuroscience Research | Principal Investigator |
| Leah R Hanson, PhD | HealthPartners Neuroscience Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States | ||
| HealthPartners Neuroscience Center |
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4 PLWD 4 Caregivers of PLWD
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Outreach-ER (Caregiver) | Caregiver to the PLWD also participating in the Outreach-ER program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER | Number of potential participant/care partner dyads contacted. Higher number indicates higher number of attempts as recruitment. | Posted | Count of Participants | Participants | 4 months |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bhavani Kashyap, PhD, MBBS | HealthPartners Institute | 651-495-6363 | Bhavani.x.kashyap@healthpartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2022 | Apr 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
Percentage 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.
| about 4 months |
| Saint Paul |
| Minnesota |
| 55130 |
| United States |
| BG001 | Outreach-ER (Caregivers of PLWD) | Caregivers of PLWD also participating in the Outreach-ER program. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Dementia Type | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Recruitment Rate for Feasibility and Acceptability of Outreach-ER | Percentage of participant/care partner dyads who enroll and consent [range: 0-100%]. Higher number indicates more feasibility. | Posted | Number | percentage of attempted recruits | 4 months |
|
|
|
| Primary | Participant Rate for Feasibility and Acceptability of Outreach-ER | Percentage of participant/care partner dyads who start Outreach-ER program [range: 0-100%]. Higher number indicates more feasibility. | Posted | Number | percentage of attempted recruits | First day of intervention |
|
|
|
| Primary | Completion Rate for Feasibility and Acceptability of Outreach-ER | Percentage of participant/care partner dyads who complete intervention (7 or more visits) [range: 0-100%]. Higher number indicates more feasibility. | Posted | Number | percentage of enrolled participants | about 4 months |
|
|
|
| Primary | Session Specific Completion Rate for Feasibility and Acceptability of Outreach-ER | Percentage 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. | Posted | Number | percentage of sessions completed | about 4 months | sessions | sessions |
|
|
|
| Primary | Questionnaire Specific Response Rate for Feasibility and Acceptability of Outreach-ER | Percentage 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. | Posted | Number | percentage of completed questionnaires | about 4 months | questionnaires | questionnaires |
|
|
|
| Secondary | Completeness of Specific Measures for Feasibility and Acceptability of Outreach-ER | Percentage of care partners that respond to all of the items on each scale [range: 0-100%]. Higher number indicates more feasibility. | Posted | Number | percentage of completed questions | about 4 months |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Outreach-ER (Caregivers of PLWD) | Caregivers of PLWD also participating in the Outreach-ER program. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D001523 | Mental Disorders |