DementiaNCT05451693

Outreach-ER: A Dementia Care Intervention Program

An observational study of Dementia, run by HealthPartners Institute at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Dementia
What is being tested?: Outreach-ER
Type of treatment: Lifestyle or therapy programme
How many people: 8 participants
Where: 2 sitesUnited States
Study dates: 8 Sep 2022to 30 Mar 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Population includes people living with dementia (PLWD) who are treated at the Regions Hospital Emergency Department in Saint Paul, MN.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Regions Hospital
Saint Paul, Minnesota, 55101
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130

Other trials in United States

About this study

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.

Conditions: Dementia
Being tested: Outreach-ER
Medical subject headings: Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Outreach-ERBehavioural
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.

Study groups in NCT05451693
Study group	Role	What they receive
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). Receives: Behavioral: Outreach-ER

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: about 4 months
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.
Measured: about 4 months

Secondary outcomes (1)

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.
Measured: about 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 202230 Mar 2023

First posted11 Jul 2022
Study start8 Sep 2022
Primary completion27 Jan 2023
Study completion30 Mar 2023

Why it stopped: Planned recruitment was not feasible.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DementiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05451693
Sponsor's protocol ID: A22-086
Status last verified: Oct 2022
First submitted: 5 Jul 2022
Last updated: 5 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dementia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Outreach-ER: A Dementia Care Intervention Program
ClinicalTrials.gov ID: NCT05451693
Acronym / sponsor ID: A22-086
Conditions: Dementia
Study type: Observational
Recruitment status: TerminatedReason stopped: Planned recruitment was not feasible.
Enrolment: 8 participants (actual)
Lead sponsor: HealthPartners InstituteUniversity, hospital or other
Study start: 8 Sep 2022 (actual)
Primary completion: 27 Jan 2023 (actual)
Study completion: 30 Mar 2023 (actual)
First posted: 11 Jul 2022 (actual)
Results: Posted 5 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Outreach-ER	–	Behavioral: Outreach-EROutreach-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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Population includes people living with dementia (PLWD) who are treated at the Regions Hospital Emergency Department in Saint Paul, MN.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Outreach-ERThe 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.	Behavioural	Outreach-ER

Primary outcome

Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER
Time frame: 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
Time frame: 4 months
Percentage of participant/care partner dyads who enroll and consent [range: 0-100%]. Higher number indicates more feasibility.
Participant Rate for Feasibility and Acceptability of Outreach-ER
Time frame: First day of intervention
Percentage of participant/care partner dyads who start Outreach-ER program [range: 0-100%]. Higher number indicates more feasibility.
Completion Rate for Feasibility and Acceptability of Outreach-ER
Time frame: 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
Time frame: 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.
Questionnaire Specific Response Rate for Feasibility and Acceptability of Outreach-ER
Time frame: 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.

1 secondary outcome

Completeness of Specific Measures for Feasibility and Acceptability of Outreach-ER
Time frame: about 4 months

Results and safety

Results posted to the registry on 5 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Outreach-ER (People Living With Dementia)	4	3
Outreach-ER (Caregiver)	4	3

Primary outcome: Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER

Time frame: 4 months. Count of participants. Unit: Participants

Measure	Outreach-ER n = 32
Value	32

Primary outcome: Recruitment Rate for Feasibility and Acceptability of Outreach-ER

Time frame: 4 months. Number. Unit: percentage of attempted recruits

Measure	Outreach-ER n = 32
Value	13

Primary outcome: Participant Rate for Feasibility and Acceptability of Outreach-ER

Time frame: First day of intervention. Number. Unit: percentage of attempted recruits

Measure	Outreach-ER n = 32
Value	13

Primary outcome: Completion Rate for Feasibility and Acceptability of Outreach-ER

Time frame: about 4 months. Number. Unit: percentage of enrolled participants

Measure	Outreach-ER n = 4
Value	75

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Outreach-ER (People Living With Dementia)	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Outreach-ER (Caregivers of PLWD)	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Dementia

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bhavani Kashyap, MBBS, PhD principal investigator

HealthPartners Neuroscience Research

Leah R Hanson, PhD principal investigator

HealthPartners Neuroscience Research

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dementia, run by HealthPartners Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER (time frame: 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05451693.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.