MedPath

Aging Brain Care Virtual Program

Not Applicable
Recruiting
Conditions
Dementia
Alzheimer Disease
Interventions
Behavioral: Aging Brain Care Virtual Program
Registration Number
NCT06245499
Lead Sponsor
Indiana University
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
860
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionAging Brain Care Virtual ProgramCare Partners in the intervention group will be approached and offered care coordination through the Aging Brain Care Virtual program
Primary Outcome Measures
NameTimeMethod
Emergency Department UtilizationDuring the 12 months of intervention

Total count of emergency department encounters per patient

Secondary Outcome Measures
NameTimeMethod
New prescriptions for antipsychotic medicationsDuring the 12 months of intervention

Total count of new prescriptions for antipsychotic medications

New prescriptions for benzodiazepine medicationsDuring the 12 months of intervention

Total count of new prescriptions for benzodiazepine medications

Anticholinergic Cognitive Burden Scale scoreBefore 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.

Acceptability of the intervention scoreDuring 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.

Feasibility of the intervention scoreDuring 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.

Appropriateness of the intervention scoreDuring 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.

Trial Locations

Locations (1)

Regenstrief Institute, Inc.

🇺🇸

Indianapolis, Indiana, United States

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