Optimizing Rural Community Health Through Dementia Detection and Care

NCT05760521 | Completed DMC

• 1 other identifier: 1851318
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer' Disease

Keywords

Rural; Multicultural; Early Detection; Multidisciplinary

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change in rates of preventable admission related to ADRD to the local hospital

  at baseline, 3 months, and 6 months post-intervention

• Change in provider knowledge related to ADRD

  at baseline, 3 months, and 6 months post-intervention

• Change in provider confidence in establishing an ADRD diagnosis and treatment plan

  at baseline, 3 months, and 6 months post-intervention

• Change in caregiver burden

  at baseline, 3 months, and 6 months post-intervention

• Change in caregiver self-efficacy

  at baseline, 3 months, and 6 months post-intervention

Study Arms (2)

Arm A: Provider Educational Intervention

EXPERIMENTAL

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

Arm B: Provider Control

NO INTERVENTION

Providers receiving AGNP assessments/recommendations only.

Interventions

Provider Educational Intervention 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 A: Provider Educational Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Florida Atlantic University: lead
• University of Miami: collaborator
• Palm Beach State College: collaborator

Study Sites (2)

Palm Beach State College

Belle Glade, Florida, 33430, United States

Location

Florida Atlantic University

Boca Raton, Florida, 33431, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not know to which Randomized group that they have been assigned (intervention or control).
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Nursing

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: March 8, 2023
• Study Start: April 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 30, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the data has been analyzed and deidentified. We expect that to be within a year of study closure (March 2024).
• Access Criteria: By Request, with approval of Data Management Officer, Research Team, and IRB Officials.

Locations

US (2)