Dementia
Conditions
Brief summary
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.
Interventions
BEHAVIORALOutreach-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.
Sponsors
HealthPartners Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PLWD with a recent Emergency department visit or admission at Regions Hospital * Diagnosis of dementia based on international classification of diseases (ICD) Codes in the medical record * Provides informed consent prior to participation * Must be able to read and speak English * PLWD Living at Home * Age \>=18 years for PLWD and their care partner
Exclusion criteria
* PLWD living in a nursing home/Long term care - Assisted living facility * Current involvement in another clinical research study/trial for care partners * PLWD medical record number (MRN) on the HealthPartners (HP) exclusion list
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Rate for Feasibility and Acceptability of Outreach-ER | First day of intervention | Percentage of participant/care partner dyads who start Outreach-ER program \[range: 0-100%\]. Higher number indicates more feasibility. |
| Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER | 4 months | Number of potential participant/care partner dyads contacted. Higher number indicates higher number of attempts as recruitment. |
| Recruitment Rate for Feasibility and Acceptability of Outreach-ER | 4 months | Percentage of participant/care partner dyads who enroll and consent \[range: 0-100%\]. Higher number indicates more feasibility. |
| Questionnaire Specific Response Rate for Feasibility and Acceptability of Outreach-ER | about 4 months | 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. |
| Completion Rate for Feasibility and Acceptability of Outreach-ER | about 4 months | Percentage of participant/care partner dyads who complete intervention (7 or more visits) \[range: 0-100%\]. Higher number indicates more feasibility. |
| Session Specific Completion Rate for Feasibility and Acceptability of Outreach-ER | about 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completeness of Specific Measures for Feasibility and Acceptability of Outreach-ER | about 4 months | Percentage of care partners that respond to all of the items on each scale \[range: 0-100%\]. Higher number indicates more feasibility. |
Countries
United States
Participant flow
Recruitment details
4 PLWD 4 Caregivers of PLWD
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Outreach-ER (Caregivers of PLWD) Caregivers of PLWD also participating in the Outreach-ER program. | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Outreach-ER (Caregivers of PLWD) | Outreach-ER (People Living With Dementia) | Total |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 4.7 | 68 years STANDARD_DEVIATION 9.8 | 66.9 years STANDARD_DEVIATION 7.7 |
| Dementia Type Alzheimer's Disease with Down Syndrome | 0 Participants | 1 Participants | 1 Participants |
| Dementia Type Late Onset Alzheimer's Disease | 0 Participants | 2 Participants | 2 Participants |
| Dementia Type Lewy Body Dementia (Mixed) | 0 Participants | 1 Participants | 1 Participants |
| Dementia Type No Dementia | 4 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: about 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Outreach-ER | Completion Rate for Feasibility and Acceptability of Outreach-ER | 75 percentage of enrolled participants |
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.
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Outreach-ER | Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER | 32 Participants |
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.
Time frame: First day of intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Outreach-ER | Participant Rate for Feasibility and Acceptability of Outreach-ER | 13 percentage of attempted recruits |
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.
Time frame: about 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Outreach-ER | Questionnaire Specific Response Rate for Feasibility and Acceptability of Outreach-ER | 67 percentage of completed questionnaires |
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.
Time frame: 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Outreach-ER | Recruitment Rate for Feasibility and Acceptability of Outreach-ER | 13 percentage of attempted recruits |
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.
Time frame: about 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Outreach-ER | Session Specific Completion Rate for Feasibility and Acceptability of Outreach-ER | 86 percentage of sessions completed |
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.
Time frame: about 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Outreach-ER | Completeness of Specific Measures for Feasibility and Acceptability of Outreach-ER | 75 percentage of completed questions |