Outreach-ER: A Dementia Care Intervention Program

NCT ID: NCT05451693

Last Updated: 2025-02-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-08

Study Completion Date

2023-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dementia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Outreach-ER

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bhavani Kashyap, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Neuroscience Research

Leah R Hanson, PhD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Neuroscience Research

Locations

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Regions Hospital

Saint Paul, Minnesota, United States

Site Status

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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A22-086

Identifier Type: -

Identifier Source: org_study_id

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