NCT06245499

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
989

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

November 5, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

January 30, 2024

Last Update Submit

November 3, 2025

Conditions

DementiaAlzheimer Disease

Keywords

TelehealthVirtual interventionAging brain care

Outcome Measures

Primary Outcomes (1)

  • Emergency Department Utilization

    Total count of emergency department encounters per patient

    During the 12 months of intervention

Secondary Outcomes (6)

  • New prescriptions for antipsychotic medications

    During the 12 months of intervention

  • New prescriptions for benzodiazepine medications

    During the 12 months of intervention

  • Anticholinergic Cognitive Burden Scale score

    Before and 12 months after initial intervention

  • Acceptability of the intervention score

    During the 12 month intervention period

  • Feasibility of the intervention score

    During the 12 month intervention period

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Aging Brain Care Virtual Program

Control

NO INTERVENTION

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.

Interventions

Aging Brain Care Virtual ProgramBEHAVIORAL

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.

Also known as: ABCV
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • enrolled in hospice at the study start (study screening)or
  • living in a long term care nursing facility.
  • 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.
  • \- Individuals who decline to participate in the ABCV intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regenstrief Institute, Inc.

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 40987722DERIVED

MeSH Terms

Conditions

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Alexia M Torke, MD, MS

    Regenstrief Institute, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

March 11, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

November 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)