Outreach-ER: A Dementia Care Intervention Program

Dementia Clinical Trial

Official title:

Outreach-ER: A Dementia Care Intervention Program

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05451693
• Other study ID #: A22-086
• Status: Terminated
• Start date: September 8, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: October 2022
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 30, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	HealthPartners Neuroscience Center	Saint Paul	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of attempted recruits for feasibility and acceptability of Outreach-ER	Number of potential participants contacted. Higher number indicates higher number of attempts as recruitment.	through study completion, an average of 1.5 years
Primary	Recruitment rate for feasibility and acceptability of Outreach-ER	Percentage of participants who enroll and consent [range: 0-100%]. Higher number indicates more feasibility.	through study completion, an average of 1.5 years
Primary	Participant rate for feasibility and acceptability of Outreach-ER	Percentage of participants who start Outreach-ER program [range: 0-100%]. Higher number indicates more feasibility.	through study completion, an average of 1.5 years
Primary	Completion rate for feasibility and acceptability of Outreach-ER	Percentage of participants who complete intervention (7 or more visits) [range: 0-100%]. Higher number indicates more feasibility.	through study completion, an average of 1.5 years
Primary	Session specific completion rate for feasibility and acceptability of Outreach-ER	Percentage of participants who complete each intervention visit [range: 0-100%]. Higher number indicates more feasibility.	through study completion, an average of 1.5 years
Primary	Questionnaire specific response rate for feasibility and acceptability of Outreach-ER	Percentage of participants who complete each questionnaire [range: 0-100%]. Higher number indicates more feasibility.	through study completion, an average of 1.5 years
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.	through study completion, an average of 1.5 years