Optimizing Rural Community Health Through Dementia Detection and Care

Alzheimer' Disease Clinical Trial

— ORCHID  

Official title:

Optimizing Rural Community Health Through Interdisciplinary Dementia Detection and Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05760521
• Other study ID #: 1851318
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Florida Atlantic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: September 30, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer' Disease
• Dementia

Intervention

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).

Locations

Country	Name	City	State
United States	Palm Beach State College	Belle Glade	Florida
United States	Florida Atlantic University	Boca Raton	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida Atlantic University	Palm Beach State College, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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