Aging Brain Care Virtual Program (ABCV)
The Aging Brain Care Virtual Program
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
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Indianapolis, Indiana, United States, 46202
- Regenstrief Institute, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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)
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
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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:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency Department Utilization
Time Frame: During the 12 months of intervention
|
Total count of emergency department encounters per patient.
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During the 12 months of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
New Prescriptions for Benzodiazepine and/or Antipsychotic Medications
Time Frame: During the 12 months of intervention
|
Total count of new prescriptions for benzodiazepine and/or antipsychotic medications per patient.
|
During the 12 months of intervention
|
|
Change in Anticholinergic Cognitive Burden Scale Score
Time Frame: Before and 12 months after initial intervention
|
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. |
Before and 12 months after initial intervention
|
|
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.
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During the 12 month intervention period
|
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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.
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During the 12 month intervention period
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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.
|
During the 12 month intervention period
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anticholinergic Cognitive Burden Scale score
Time Frame: Before and 12 months after 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. |
Before and 12 months after intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexia M Torke, MD, MS, Regenstrief Institute, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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