Optimizing Rural Community Health Through Dementia Detection and Care

NCT ID: NCT05760521

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alzheimer' Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants
Patients will not know to which Randomized group that they have been assigned (intervention or control).

Study Groups

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Arm A: Provider Educational Intervention

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.

Group Type EXPERIMENTAL

Provider Educational Intervention

Intervention Type 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).

Arm B: Provider Control

Providers receiving AGNP assessments/recommendations only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Provider Educational Intervention

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role collaborator

Palm Beach State College

UNKNOWN

Sponsor Role collaborator

Florida Atlantic University

OTHER

Sponsor Role lead

Responsible Party

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Lisa A Wiese

Associate Professor, Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa A Wiese

Role: PRINCIPAL_INVESTIGATOR

Florida Atlantic University, C.E. Lynn College of Nursing

Magdalena I Tolea, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Joanne Pulido

Role: PRINCIPAL_INVESTIGATOR

Palm Beach State College

Locations

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Palm Beach State College

Belle Glade, Florida, United States

Site Status

Florida Atlantic University

Boca Raton, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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1851318

Identifier Type: -

Identifier Source: org_study_id

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