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| ID | Type | Description | Link |
|---|---|---|---|
| AZ160032 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| Richard L. Roudebush VA Medical Center | FED |
| Cleveland State University | OTHER |
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This study will test the effectiveness of an intervention for Veterans diagnosed with Alzheimer's Disease (AD) or Traumatic Brain Injury (TBI) and the burden on their informal (family/friend) caregiver.
The majority of people with Alzheimer's (AD) and Traumatic brain Injury (TBI) are cared for in primary care settings and receive significant amounts of care and assistance in activities of daily living from family members or friends.
The ABC ANSWERS intervention will incorporate and integrate the common features of an evidence-based collaborative care model for brain care, while also attending to the implementation barriers of delivering care and skills to dyads of patients with AD and TBI and their family caregivers.
The study team will conduct a 1-year randomized control trial (RCT) designed to improve the Quality of Life (QoL) of Veterans with AD and TBI, and their family caregivers, and decrease their family caregivers' burden. The dyads in the intervention group will receive primary care plus ABC ANSWERS. The control group will receive primary care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Primary Care |
|
| Intervention | Experimental | Primary Care plus ABC ANSWERS intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABC ANSWERS | Other | Primary Care plus ABC ANSWERS |
| |
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Caregivers Quality of Life at 12 months | Measure of quality of life using the 12 item Logsdon's Quality of Life scale. Items are scored on a scale from 0-3, "poor to excellent". The higher the score, the better the reporting of item. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Veterans Quality of Life at 12 months | Measure of quality of life using the 12 item Logsden's Quality of Life scale. Items are scored on a scale from 0-3, "poor to excellent". The higher the score, the better the reporting of item. | Baseline to 12 months |
| Change from baseline Caregiver Burden at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VAMC | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32306982 | Derived | Carnahan JL, Judge KS, Daggy JK, Slaven JE, Coleman N, Fortier EL, Suelzer C, Fowler NR. Supporting caregivers of veterans with Alzheimer's disease and traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2020 Apr 19;21(1):340. doi: 10.1186/s13063-020-4199-1. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D000544 | Alzheimer Disease |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The outcomes assessor is blinded to which arm a dyad is enrolled.
| Other |
Primary Care as usual |
|
Caregiver burden is measured using the Oberst Caregiver Burden Scale (OCBS). This is a valid 15 item questionnaire that rates 15 different types of caregiving tasks for informal caregivers based on perceived time and difficulty of the task. For each item the caregiver chooses a value from not difficult(0) to extremely difficult (5). Scores are averaged across 15 items of the time and difficulty subscales, thus achieving a score between 1 and 5 for each. |
| Baseline to 12 months |
| Change from baseline Veteran depression at 12 months | Measure of Veteran depression using the Center for Epidemilogic Scale -Depression (CESD).This is a twenty item questionnaire comprising of six scales reflecting major facets of depression. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology. | Baseline to 12 months |
| Change from baseline Caregiver depression at 12 months | Measure of Caregiver depression using the Center for Epidemilogic Scale -Depression (CESD).This is a twenty item questionnaire comprising of six scales reflecting major facets of depression. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology. | Baseline to12 months |
| Change from baseline Veteran anxiety at 12 months | Measure of anxiety using the Generalized Anxiety Disorder Scale (GAD-7). This is a seven item anxiety scale with a total score from 0-21. Items are scored from "Not at all" (0) to "Nearly everyday" (3). The higher the score, the more often anxiety symptoms are endorsed. | Baseline to 12 months |
| Change from Caregiver anxiety at 12 months | Measure of anxiety using the Generalized Anxiety Disorder Scale (GAD-7). This is a seven item anxiety scale with a total score from 0-21. Items are scored from "Not at all" (0) to "Nearly everyday" (3). The higher the score, the more often anxiety symptoms are endorsed. | Baseline to 12 months |
| Change from Caregiver dyadic strain at 12 months | This is a 12 item scale ranging from strongly agree (3) to strongly disagree (0). The higher the score the more the respondent agrees or endorses relationship strain. | Baseline to 12 months |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D003704 | Dementia |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |