Optimizing Rural Community Health Through Dementia Detection and Care (ORCHID)

Optimizing Rural Community Health Through Interdisciplinary Dementia Detection and Care

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer' Disease
• Intervention / Treatment: Other: Provider Educational Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Belle Glade, Florida, United States, 33430
      • Palm Beach State College
    • Boca Raton, Florida, United States, 33431
      • Florida Atlantic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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).
No Intervention: Arm B: Provider Control; Providers receiving AGNP assessments/recommendations only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Florida Atlantic University
• Collaborators: University of Miami; Palm Beach State College
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Rural; Early Detection; Multidisciplinary; Multicultural
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: 1851318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After the data has been analyzed and deidentified. We expect that to be within a year of study closure (March 2024).
• IPD Sharing Access Criteria: By Request, with approval of Data Management Officer, Research Team, and IRB Officials.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No