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Alzheimer' DiseaseORCHIDNCT05760521

Optimizing Rural Community Health Through Dementia Detection and Care

A study testing Provider Educational Intervention in people with Alzheimer' Disease, run by Florida Atlantic University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer' Disease
What is being tested?
Provider Educational Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
2 sitesUnited States
Study dates
1 Apr 2022to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Palm Beach State College

    Belle Glade, Florida, 33430

  • Florida Atlantic University

    Boca Raton, Florida, 33431

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Provider Educational Intervention
Keywords
Rural, Multicultural, Early Detection, Multidisciplinary
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Provider Educational InterventionOther

    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).

Study groups in NCT05760521
Study groupRoleWhat they receive
Arm A: Provider Educational InterventionExperimentalProviders 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.
Receives: Other: Provider Educational Intervention
Arm B: Provider ControlNo interventionProviders receiving AGNP assessments/recommendations only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at baseline, 3 months, 6 months, and 12 months post-intervention

  2. 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.

    Measured: baseline, 3 months, 6 months, and 12 months post-intervention

  3. 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

    Measured: : 6 weeks

  4. 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.

    Measured: 6 weeks

Secondary outcomes (5)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2023
  2. Study start1 Apr 2022
  3. Primary completion1 Sep 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05760521
Sponsor's protocol ID
1851318
Acronym
ORCHID
Status last verified
Oct 2023
First submitted
24 Jan 2023
Last updated
6 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Provider Educational Intervention in people with Alzheimer' Disease, run by Florida Atlantic University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in rates of new dementia diagnosis and treatment (time frame: at baseline, 3 months, 6 months, and 12 months post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05760521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.

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