Aging Brain Care Virtual Program

Alzheimer Disease Clinical Trial

— ABCV  

Official title:

The Aging Brain Care Virtual Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245499
• Other study ID #: FY23_Demo2_Torke
• Secondary ID: 20249U54AG063546
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: November 15, 2025

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: Emily S Burke, BA
• Phone: 317-274-9047
• Email: esburke[@]regenstrief.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 860
• Est. completion date: November 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	Regenstrief Institute, Inc.	Indianapolis	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Indiana University	Indiana University Health, National Institute on Aging (NIA), Regenstrief Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Emergency Department Utilization	Total count of emergency department encounters per patient	During the 12 months of intervention
Secondary	New prescriptions for antipsychotic medications	Total count of new prescriptions for antipsychotic medications	During the 12 months of intervention
Secondary	New prescriptions for benzodiazepine medications	Total count of new prescriptions for benzodiazepine medications	During the 12 months of intervention