Aging Brain Care Virtual Program

NCT ID: NCT06245499

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

989 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2025-10-31

Brief Summary

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The program involves a virtual intervention to be delivered by RN or SW care coordinators over one year. Every care partner will receive monthly virtual visits during the first 3 months and then quarterly or more depending on assessed need. The intervention relies on a tailored approach in which patient and caregiver needs are identified during visits using validated assessment tools and addressed with standardized protocols. Protocols include management of behavioral/psychological symptoms of dementia, caregiver stress, medication management, comorbidity management and advance care planning.

Detailed Description

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Conditions

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Dementia Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Care Partners in the intervention group will be approached and offered care coordination through the Aging Brain Care Virtual program

Group Type EXPERIMENTAL

Aging Brain Care Virtual Program

Intervention Type BEHAVIORAL

The program involves a virtual intervention to be delivered by RN or SW care coordinators over one year. Every care partner will receive monthly virtual visits during the first 3 months and then quarterly or more depending on assessed need. The intervention relies on a tailored approach in which patient and caregiver needs are identified during visits using validated assessment tools and addressed with standardized protocols. Protocols include management of behavioral/psychological symptoms of dementia, caregiver stress, medication management, comorbidity management and advance care planning.

Control

Care partners in the control group will not be approached, but outcomes data will be collected from the EMR for comparison with the intervention group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aging Brain Care Virtual Program

The program involves a virtual intervention to be delivered by RN or SW care coordinators over one year. Every care partner will receive monthly virtual visits during the first 3 months and then quarterly or more depending on assessed need. The intervention relies on a tailored approach in which patient and caregiver needs are identified during visits using validated assessment tools and addressed with standardized protocols. Protocols include management of behavioral/psychological symptoms of dementia, caregiver stress, medication management, comorbidity management and advance care planning.

Intervention Type BEHAVIORAL

Other Intervention Names

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ABCV

Eligibility Criteria

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Inclusion Criteria

* 65 and older,
* active primary care patient (visit in past 14 months),
* diagnosis of Alzheimer's disease and related dementias (ADRD) based on ICD criteria in primary care problems list.


* 18 and older,
* able to access a phone or computer for intervention delivery in English, and
* identified in the EMR as the emergency contact or as the primary care partner.

Exclusion Criteria

* enrolled in hospice at the study start (study screening)or
* living in a long term care nursing facility.


\- Individuals who decline to participate in the ABCV intervention
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Regenstrief Institute, Inc.

OTHER

Sponsor Role collaborator

Indiana University Health

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Alexia M. Torke

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexia M Torke, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Regenstrief Institute, Inc.

Locations

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Regenstrief Institute, Inc.

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Sauerteig-Rolston MR, Fowler NR, Sachs GA, Boustani M, Slaven J, Monahan PO, Burke ES, Higbie A, Torke AM. Pragmatic trial of a virtual dementia collaborative care management program: protocol for the Aging Brain Care Virtual (ABCV) program. BMJ Open. 2025 Sep 23;15(9):e108800. doi: 10.1136/bmjopen-2025-108800.

Reference Type DERIVED
PMID: 40987722 (View on PubMed)

Other Identifiers

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20249

Identifier Type: OTHER

Identifier Source: secondary_id

U54AG063546

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FY23_Demo2_Torke

Identifier Type: -

Identifier Source: org_study_id

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