Aging Brain Care Virtual Program (ABCV)

The 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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease
• Intervention / Treatment: Behavioral: Aging Brain Care Virtual Program

• Study Type: Interventional
• Enrollment (Actual): 989
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Regenstrief Institute, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Patient 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.

Patient Exclusion Criteria:

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

Care Partners Inclusion Criteria:

• 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.

Care Partners Exclusion Criteria:

- Individuals who decline to participate in the ABCV intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.; Other Names: ABCV
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Department Utilization	Total count of emergency department encounters per patient	During the 12 months of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New prescriptions for antipsychotic medications	Total count of new prescriptions for antipsychotic medications	During the 12 months of intervention
New prescriptions for benzodiazepine medications	Total count of new prescriptions for benzodiazepine medications	During the 12 months of intervention
Anticholinergic Cognitive Burden Scale score	Total score rating the anticholinergic burden of medications the patient is taking There are 88 medications on the Anticholinergic Cognitive Burden Scale. Possible anticholinergics include those listed with a score of 1; Definite anticholinergics include those listed with a score of 2 or 3. The overall ACB score is calculated by adding the score for each possible or definite anticholinergic medication that the patient is taking. An ACB Scale score can be as low as 0. The vast majority of patients have an ACB score at or below 4. Scores of 1 are low, 2 are moderate and anything above 3 is considered high. There is no published max score on the ACB scale, however, scores above 4 are somewhat uncommon. The top score could be as high as 264 (88x3) A higher ACB score indicates higher cognitive burden. Higher scores indicate worse outcomes.	Before and 12 months after initial intervention
Acceptability of the intervention score	Acceptability of Intervention Measure (AIM) Scores range from 4 to 20. Cut-off scores for interpretation are not yet available however higher scores indicate superior psychometric quality.	During the 12 month intervention period
Feasibility of the intervention score	Feasibility of Intervention Measure (FIM) Scores range from 4 to 20. Cut-off scores for interpretation are not yet available however higher scores indicate superior psychometric quality.	During the 12 month intervention period
Appropriateness of the intervention score	Intervention Appropriateness Measure (IAM) Scores range from 4 to 20. Cut-off scores for interpretation are not yet available however higher scores indicate superior psychometric quality.	During the 12 month intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anticholinergic Cognitive Burden Scale score	Total score rating the anticholinergic burden of medications the patient is taking There are 88 medications on the Anticholinergic Cognitive Burden Scale. Possible anticholinergics include those listed with a score of 1; Definite anticholinergics include those listed with a score of 2 or 3. The overall ACB score is calculated by adding the score for each possible or definite anticholinergic medication that the patient is taking. An ACB Scale score can be as low as 0. The vast majority of patients have an ACB score at or below 4. Scores of 1 are low, 2 are moderate and anything above 3 is considered high. There is no published max score on the ACB scale, however, scores above 4 are somewhat uncommon. The top score could be as high as 264 (88x3) A higher ACB score indicates higher cognitive burden. Higher scores indicate worse outcomes.	Before and 12 months after intervention

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Aging (NIA); Indiana University Health; Regenstrief Institute, Inc.
• Investigators: Principal Investigator: Alexia M Torke, MD, MS, Regenstrief Institute, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Telehealth; Virtual intervention; Aging brain care
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: FY23_Demo2_Torke; U54AG063546 (U.S. NIH Grant/Contract); 20249 (Other Identifier: Indiana University Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No