Skip to main content
OpenTrials
Completed

NCT Number: NCT06245499

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regenstrief Institute, Inc.

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aging Brain Care Virtual Program

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.

Other names: ABCV

Primary outcomes

  1. Emergency Department Utilization

    Time frame: During the 12 months of intervention

    Total count of emergency department encounters per patient

Secondary outcomes

  1. New prescriptions for antipsychotic medications

    Time frame: During the 12 months of intervention

    Total count of new prescriptions for antipsychotic medications

  2. New prescriptions for benzodiazepine medications

    Time frame: During the 12 months of intervention

    Total count of new prescriptions for benzodiazepine medications

  3. Anticholinergic Cognitive Burden Scale score

    Time frame: Before and 12 months after initial intervention

    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.

  4. Acceptability of the intervention score

    Time frame: During the 12 month intervention period

    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.

  5. Feasibility of the intervention score

    Time frame: During the 12 month intervention period

    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.

  6. Appropriateness of the intervention score

    Time frame: During the 12 month intervention period

    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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana University Health
  • National Institute on Aging (NIA)
  • Regenstrief Institute, Inc.

Registry information

Official study title

The Aging Brain Care Virtual Program

Acronym: ABCV

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2024
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.