Clinical trial NCT05760521: Optimizing Rural Community Health Through Dementia Detection and Care
Official title: Optimizing Rural Community Health Through Interdisciplinary Dementia Detection and Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer' Disease
Keywords: Rural
Multicultural
Early Detection
Multidisciplinary
Lead sponsor: Florida Atlantic University
Sponsor class: OTHER
Collaborators: name: University of Miami
name: Palm Beach State College
First posted: 2023-03-08
Enrollment: 336
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged 50 years and older
* Lives in the Glades Area of Florida
* Lives in the community/ be non-institutionalized
* Has no known diagnosis of Alzheimer's Disease and Related Dementias
* Speaks either English, Spanish, or Creole
* Has no known plans to move out of the Glades Area in the next 12 months

Exclusion Criteria:

* Previous diagnosis of a dementia-related illness
* Aged under 50 years

Primary outcomes:
measure: Change in rates of new dementia diagnosis and treatment
timeFrame: at baseline, 3 months, 6 months, and 12 months post-intervention
measure: Change in rates of referrals to Area Support Services
timeFrame: baseline, 3 months, 6 months, and 12 months post-intervention
measure: Change in AD knowledge
timeFrame: : 6 weeks
measure: Change in AD literacy treatment plan.
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in rates of preventable admission related to ADRD to the local hospital
timeFrame: at baseline, 3 months, and 6 months post-intervention
measure: Change in provider knowledge related to ADRD
timeFrame: at baseline, 3 months, and 6 months post-intervention
measure: Change in provider confidence in establishing an ADRD diagnosis and treatment plan
timeFrame: at baseline, 3 months, and 6 months post-intervention
measure: Change in caregiver burden
timeFrame: at baseline, 3 months, and 6 months post-intervention
measure: Change in caregiver self-efficacy
timeFrame: at baseline, 3 months, and 6 months post-intervention
Other outcomes:
Locations:
city: Belle Glade
country: United States
facility: Palm Beach State College
state: Florida
city: Boca Raton
country: United States
facility: Florida Atlantic University
state: Florida
Study officials:
affiliation: Florida Atlantic University, C.E. Lynn College of Nursing
name: Lisa A Wiese
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Magdalena I Tolea, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palm Beach State College
name: Joanne Pulido
role: PRINCIPAL_INVESTIGATOR
References: