DementiaABCVNCT06245499
Aging Brain Care Virtual Program
A study testing Aging Brain Care Virtual Program in people with Dementia and Alzheimer Disease, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Aging Brain Care Virtual Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 987 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to 31 Oct 2025
- Phase
- Interventional
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
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Regenstrief Institute, Inc.
Indianapolis, Indiana, 46202
About this study
Official title: 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.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Aging Brain Care Virtual Program
- Keywords
- Telehealth, Virtual intervention, Aging brain care
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aging Brain Care Virtual ProgramBehavioural
Also called ABCV
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Care Partners in the intervention group will be approached and offered care coordination through the Aging Brain Care Virtual program Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department Utilization
Total count of emergency department encounters per patient.
Measured: During the 12 months of intervention
Secondary outcomes (5)
New Prescriptions for Benzodiazepine and/or Antipsychotic Medications
Total count of new prescriptions for benzodiazepine and/or antipsychotic medications per patient.
Measured: During the 12 months of intervention
Change in Anticholinergic Cognitive Burden Scale Score
The Anticholinergic Cognitive Burden Scale (ACB) provides a 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the 12 month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start11 Mar 2024
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 987 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Regenstrief Institute, Inc., Indiana University Health
- Responsible party
- Principal investigator, Alexia M. Torke, Indiana University
- Investigators
- Alexia M Torke, MD, MS, Principal investigator, Regenstrief Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245499
- Sponsor's protocol ID
- FY23_Demo2_Torke
- Other IDs
- 20249, U54AG063546
- Acronym
- ABCV
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2024
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40987722