Alzheimer Disease, Dementia
Conditions
Keywords
Telehealth, Virtual intervention, Aging brain care
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.
Interventions
BEHAVIORALAging 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.
Sponsors
Indiana University
National Institute on Aging (NIA)
Regenstrief Institute, Inc.
Indiana University Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department Utilization | During the 12 months of intervention | Total count of emergency department encounters per patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New Prescriptions for Benzodiazepine and/or Antipsychotic Medications | During the 12 months of intervention | Total count of new prescriptions for benzodiazepine and/or antipsychotic medications per patient. |
| Change in Anticholinergic Cognitive Burden Scale Score | 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. |
| Acceptability of the Intervention Score | 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. |
| Feasibility of the Intervention Score | 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. |
| Appropriateness of the Intervention Score | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlexia M Torke, MD, MS
Regenstrief Institute, Inc.
Participant flow
Recruitment details
We identified 24 primary care clinics and randomly assigned half the clinics (12) to each arm. Within each arm we randomly selected 430 patients living with dementia (PLWD), based on an ICD-10 diagnosis of dementia. For the intervention arm, staff called the care partner to invite participation in ABCV. Calls occurred between 3/11/24 and 7/31/24.
Pre-assignment details
Our planned enrollment was 860 patients. 858 were included (2 were excluded because they were duplicate records). Care partners were only considered enrolled if they agreed to participate in the ABCV intervention. There were 129 care partners who agreed to participate in ABCV. The total enrollment was 858 patients and 129 care partners.
Baseline characteristics
| Characteristic | — |
|---|---|
| ADRD ICD-10 list in EMR Alzheimer's Disease | 112 Participants |
| ADRD ICD-10 list in EMR Other | 56 Participants |
| ADRD ICD-10 list in EMR Unspecified Dementia | 272 Participants |
| ADRD ICD-10 list in EMR Vascular Dementia | 29 Participants |
| Age, Continuous | 82.1 years STANDARD_DEVIATION 7.7 |
| Area Deprivation Index | 63 score on a scale |
| Comorbidities Arthritis | 254 Participants |
| Comorbidities Cancer | 90 Participants |
| Comorbidities Chronic lung disease | 241 Participants |
| Comorbidities Congestive heart failure | 117 Participants |
| Comorbidities Coronary artery disease | 192 Participants |
| Comorbidities Depression | 182 Participants |
| Comorbidities Diabetes | 535 Participants |
| Comorbidities Hypertension | 372 Participants |
| Comorbidities Stroke | 58 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 421 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Geographic Region Rural | 205 Participants |
| Geographic Region Urban | 338 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 142 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 343 Participants |
| Sex: Female, Male Female | 278 Participants |
| Sex: Female, Male Male | 152 Participants |
| Years since ADRD diagnosis | 2.3 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 15 / 430 | 0 / 0 |
| other Total, other adverse events | 84 / 430 | 0 / 129 |
| serious Total, serious adverse events | 48 / 430 | 0 / 0 |
Outcome results
None listed