NCT Number: NCT05760521
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.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Palm Beach State College, Belle Glade, Florida, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: at baseline, 3 months, 6 months, and 12 months post-intervention
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: baseline, 3 months, 6 months, and 12 months post-intervention
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: : 6 weeks
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
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: at baseline, 3 months, and 6 months post-intervention
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
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
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
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
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.
Florida Atlantic University
Other
Optimizing Rural Community Health Through Interdisciplinary Dementia Detection and Care
Acronym: ORCHID
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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