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

Primary Purpose

Alzheimer' Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Provider Educational Intervention
Sponsored by
Florida Atlantic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer' Disease focused on measuring Rural, Multicultural, Early Detection, Multidisciplinary

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Palm Beach State College
  • Florida Atlantic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm A: Provider Educational Intervention

Arm B: Provider Control

Arm Description

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.

Providers receiving AGNP assessments/recommendations only.

Outcomes

Primary Outcome Measures

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.
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.
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
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
January 24, 2023
Last Updated
October 4, 2023
Sponsor
Florida Atlantic University
Collaborators
University of Miami, Palm Beach State College
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1. Study Identification

Unique Protocol Identification Number
NCT05760521
Brief Title
Optimizing Rural Community Health Through Dementia Detection and Care
Acronym
ORCHID
Official Title
Optimizing Rural Community Health Through Interdisciplinary Dementia Detection and Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida Atlantic University
Collaborators
University of Miami, Palm Beach State College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer' Disease
Keywords
Rural, Multicultural, Early Detection, Multidisciplinary

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients will not know to which Randomized group that they have been assigned (intervention or control).
Allocation
Randomized
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Provider Educational Intervention
Arm Type
Experimental
Arm Description
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 Title
Arm B: Provider Control
Arm Type
No Intervention
Arm Description
Providers receiving AGNP assessments/recommendations only.
Intervention Type
Other
Intervention Name(s)
Provider Educational Intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in rates of new dementia diagnosis and treatment
Description
The intervention and control groups will be compared on rates of dementia diagnosis and treatment at four different time points; baseline and post-intervention.
Time Frame
at baseline, 3 months, 6 months, and 12 months post-intervention
Title
Change in rates of referrals to Area Support Services
Description
The intervention and control groups will be compared on rates of referrals to support service at four different time points; baseline and post-intervention.
Time Frame
baseline, 3 months, 6 months, and 12 months post-intervention
Title
Change in AD knowledge
Description
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
Time Frame
: 6 weeks
Title
Change in AD literacy treatment plan.
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in rates of preventable admission related to ADRD to the local hospital
Description
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.
Time Frame
at baseline, 3 months, and 6 months post-intervention
Title
Change in provider knowledge related to ADRD
Description
Alzheimer's Disease Knowledge Scale (ADKS) will be administered at baseline, and at three different time points post-intervention.
Time Frame
at baseline, 3 months, and 6 months post-intervention
Title
Change in provider confidence in establishing an ADRD diagnosis and treatment plan
Description
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.
Time Frame
at baseline, 3 months, and 6 months post-intervention
Title
Change in caregiver burden
Description
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.
Time Frame
at baseline, 3 months, and 6 months post-intervention
Title
Change in caregiver self-efficacy
Description
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.
Time Frame
at baseline, 3 months, and 6 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A Wiese
Organizational Affiliation
Florida Atlantic University, C.E. Lynn College of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Magdalena I Tolea, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanne Pulido
Organizational Affiliation
Palm Beach State College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palm Beach State College
City
Belle Glade
State/Province
Florida
ZIP/Postal Code
33430
Country
United States
Facility Name
Florida Atlantic University
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Optimizing Rural Community Health Through Dementia Detection and Care

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