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| Name | Class |
|---|---|
| University of Miami | OTHER |
| Palm Beach State College | UNKNOWN |
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The overall goal of this one-year study is to test a comprehensive protocol for Alzheimer's Disease and Related Dementias (ADRD) diagnosis and care management that can be used as a model for rural communities, which experience low rates of dementia diagnosis and treatment.
The ORCHID study integrates 1) A one-group community educational intervention focused on increasing community awareness of brain-health promoting behaviors and dementia literacy and knowledge; and 2) A primary care provider dementia educational intervention designed to improve provider knowledge and confidence in detecting, diagnosing, and treating patients with cognitive impairment, with the goal of increasing ADRD diagnosis and treatment rates, reducing dementia-related hospitalization rates, increasing utilization of available local support services, and improving caregiver-related outcomes.
The community education intervention is a 6-week culturally-relevant educational program focused on brain health promotion. Effects of the community intervention on dementia knowledge and literacy will be assessed with a pre-post analytic approach using paired t-tests to compare changes in mean AD knowledge and literacy. The provider dementia educational intervention uses a cluster-randomized trial design with participating primary care provider offices randomly assigned to either receive the intervention (Arm A) or the control group (Arm B). Providers assigned to Arm A receive an educational intervention that includes training in ADRD detection, diagnosis, and care management. Providers assigned to Arm B do not receive educational intervention. Both groups receive the following: detailed reports from neuropsychological testing performed by a study clinician, hands-on training of provider office staff on dementia screening tools, and support with referrals to local support services. The two study groups (Arms A and B) will be compared on: 1) change in provider dementia knowledge and confidence, caregiver burden and self-efficacy; and 2) rates of dementia diagnosis and treatment, rates of dementia-related hospital admissions, and rates of referral to support service. A generalized linear mixed model analytic approach will be used to assess the effect of the provider intervention on study outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Provider Educational Intervention | Experimental | Providers receiving education/support from neurology teams, Adult Gerontological Nurse Practitioner (AGNP) assessments/recommendations, and training of office staff regarding ADRD and community resources support for patients/caregivers. |
|
| Arm B: Provider Control | No Intervention | Providers receiving AGNP assessments/recommendations only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provider Educational Intervention | Other | Following the informed consent (10 min) and sociodemographic survey (5 minutes), the providers in Arm A will be offered education of two days, six hours each day, with support and follow-up. They will also be asked to complete brief knowledge and confidence surveys pre-post-intervention (30 minutes total). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in rates of new dementia diagnosis and treatment | The intervention and control groups will be compared on rates of dementia diagnosis and treatment at four different time points; baseline and post-intervention. | at baseline, 3 months, 6 months, and 12 months post-intervention |
| Change in rates of referrals to Area Support Services | The intervention and control groups will be compared on rates of referrals to support service at four different time points; baseline and post-intervention. | baseline, 3 months, 6 months, and 12 months post-intervention |
| Change in AD knowledge | Alzheimer's Disease Knowledge Scale (ADKS) will be collected from participants in the community educational intervention before (week 0) and immediately after the intervention (week 6). Scores on the ADKS range from 0 to 13, with higher scores indicating greater knowledge | : 6 weeks |
| Change in AD literacy treatment plan. | Dementia Literacy Assessment (DELA) will be administered as part of the community educational intervention before (week 0) and immediately after the intervention (week 6). DELA consists of 25 items scored 0=incorrect/1=correct. Total DELA score ranges from 0 to 25 with a higher score being indicative of greater dementia literacy. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in rates of preventable admission related to ADRD to the local hospital | The intervention and control groups will be compared on rates of hospitalization for ADRD-related complications, at baseline and at three different time points post-intervention. | at baseline, 3 months, and 6 months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa A Wiese | Florida Atlantic University, C.E. Lynn College of Nursing | Principal Investigator |
| Magdalena I Tolea, PhD | University of Miami | Principal Investigator |
| Joanne Pulido | Palm Beach State College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palm Beach State College | Belle Glade | Florida | 33430 | United States | ||
| Florida Atlantic University |
Data will be de-identified and stored on the PI's university Biomedical Health Research Informatics Core (BHRIC) which is an isolated and independently secured infrastructure managed by the FAU Office of Information technology. The BHRIC Data managed system includes limited access controls, software firewalls, and network-wide virus protection, and daily backups. Data export for analysis is expected to be automated export procedures allowing for seamless download of data into Excel or other widely used statistical packages (SPSS, SAS). Data output tables will be password protected and maintained via password protected university computers. Limited information (informed consents) will be maintained on paper, numerically coded, and secured under lock and key access (further described under the "Informed Consents" section.
After the data has been analyzed and deidentified. We expect that to be within a year of study closure (March 2024).
By Request, with approval of Data Management Officer, Research Team, and IRB Officials.
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Patients will not know to which Randomized group that they have been assigned (intervention or control).
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| Change in provider knowledge related to ADRD |
Alzheimer's Disease Knowledge Scale (ADKS) will be administered at baseline, and at three different time points post-intervention. |
| at baseline, 3 months, and 6 months post-intervention |
| Change in provider confidence in establishing an ADRD diagnosis and treatment plan | General Practitioners' Attitude and Confidence Scale for Dementia (GPACS-D) will be administered at baseline, and at three different time points post-intervention, in the intervention and control groups. Total scores range from 15 to 75, with higher scores indicating greater confidence and attitudes towards dementia. | at baseline, 3 months, and 6 months post-intervention |
| Change in caregiver burden | The 12-item Zarit Burden Inventory (ZBI) will be collected at baseline, and at three different time points post-intervention, in the intervention and control groups. Scores range from 0 to 48, with higher scores indicating greater burden. | at baseline, 3 months, and 6 months post-intervention |
| Change in caregiver self-efficacy | The Revised Scale for Caregiver Self-Efficacy (RSCSE) will be administered at baseline, and at three different time points post-intervention, in the intervention and control groups. RSCSE consists of 3 subscales (Self-Efficacy for Obtaining Respite; Self-Efficacy for Responding to Disruptive Patient Behaviors; and Self-Efficacy for Controlling Upsetting Thoughts about Caregiving), each consisting of 5 statements scored on a 0-100 with higher scores indicating better self-efficacy. | at baseline, 3 months, and 6 months post-intervention |
| Boca Raton |
| Florida |
| 33431 |
| United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |