Outreach-ER: A Dementia Care Intervention Program

Sponsor

HealthPartners Institute (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05451693

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Behavioral: Outreach-ER

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Outreach-ER: A Dementia Care Intervention Program

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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/PLWD.	Behavioral: 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.

Arm

Intervention/Treatment

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/PLWD.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Number of attempted recruits for feasibility and acceptability of Outreach-ER [through study completion, an average of 1.5 years]
Number of potential participants contacted. Higher number indicates higher number of attempts as recruitment.
Recruitment rate for feasibility and acceptability of Outreach-ER [through study completion, an average of 1.5 years]
Percentage of participants who enroll and consent [range: 0-100%]. Higher number indicates more feasibility.
Participant rate for feasibility and acceptability of Outreach-ER [through study completion, an average of 1.5 years]
Percentage of participants who start Outreach-ER program [range: 0-100%]. Higher number indicates more feasibility.
Completion rate for feasibility and acceptability of Outreach-ER [through study completion, an average of 1.5 years]
Percentage of participants 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 [through study completion, an average of 1.5 years]
Percentage of participants who complete each intervention visit [range: 0-100%]. Higher number indicates more feasibility.
Questionnaire specific response rate for feasibility and acceptability of Outreach-ER [through study completion, an average of 1.5 years]
Percentage of participants who complete each questionnaire [range: 0-100%]. Higher number indicates more feasibility.

Secondary Outcome Measures

Completeness of specific measures for feasibility and acceptability of Outreach-ER [through study completion, an average of 1.5 years]
Percentage of care partners that respond to all of the items on each scale [range: 0-100%]. Higher number indicates more feasibility.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regions Hospital	Saint Paul	Minnesota	United States	55101
2	HealthPartners Neuroscience Center	Saint Paul	Minnesota	United States	55130

Sponsors and Collaborators

HealthPartners Institute

Investigators

Principal Investigator: Bhavani Kashyap, MBBS, PhD, HealthPartners Neuroscience Research
Principal Investigator: Leah R Hanson, PhD, HealthPartners Neuroscience Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

HealthPartners Institute

ClinicalTrials.gov Identifier:

NCT05451693

Other Study ID Numbers:

A22-086

First Posted:

Jul 11, 2022

Last Update Posted:

Aug 3, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dementia

Study Results

No Results Posted as of Aug 3, 2022