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Behavioral Intervention

Psychoeducational Skills Training for Early-Stage Alzheimer's Disease

N/A
Recruiting
Led By David W. Coon, PhD
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
EPs must have a confirmed diagnosis of OR symptoms consistent with early-stage dementia
All participants - Care Partners (CP) and Early-Stage People (EP) - will be at least 18 years of age and speak, read, and write English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up t1 - t2 assessments (baseline to 3 months)
Awards & highlights

Study Summary

This trial is designed to help people with early-stage memory loss and their care partners. It provides education and skill-training to reduce stress, enhance well-being, manage challenges, and plan for the future. Feedback from participants will be used to improve the program.

Who is the study for?
This trial is for pairs of individuals where one person has early-stage memory loss and the other is their primary, unpaid caregiver. Both must be adults who speak English or Spanish. The person with memory loss should have a diagnosis or symptoms of early dementia and not live in an institution. Caregivers need to be closely involved with them.Check my eligibility
What is being tested?
The EPIC II project tests a virtual psychoeducational skills training program for people with early-stage memory issues and their caregivers. It aims to reduce stress, improve well-being, manage challenges, and plan ahead through Zoom sessions.See study design
What are the potential side effects?
Since this intervention involves educational and skill-training sessions rather than medication, traditional side effects are not expected; however, participants may experience emotional discomfort discussing sensitive topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with or show symptoms of early-stage dementia.
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I am over 18 and can communicate in English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~t1 - t2 assessments (baseline to 3 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and t1 - t2 assessments (baseline to 3 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
EP Quality of Life
EP and CP Emotional well-being
Secondary outcome measures
Communication Skills and Support within the Dyad
EP and CP Care preparedness
Knowledge and Use of Services for People with Dementia and their Care Partners
Other outcome measures
Initial incremental cost effectiveness of EPIC compared with Wait List Comparison condition

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EPIC AExperimental Treatment1 Intervention
Group A will start the EPIC intervention immediately after assessment 1. The EPIC program consists of a 7-session, psychoeducational skills training intervention, held via Zoom, designed to provide education and skills on how to prepare for the future and reduce stress regarding memory changes and loss for both the person with early-stage dementia and their care partner. Following the 7 EPIC sessions, participants will attend monthly booster sessions, held via Zoom, to reinforce the skills/lessons. Participants may voluntarily choose to continue attending booster sessions through 2024.
Group II: EPIC B (WLC)Active Control1 Intervention
Group B - the wait list comparison (WLC) group - will have a 75-minute group education session (comparator intervention), held via Zoom, about 3 weeks after baseline assessment. The WLC session is an overview of memory loss/dementia and its related impact for EPs and CPs and an overview of aging network services in the community. They will receive a brief telephone check-in call approximately 3 weeks before the T2 assessment. The WLC group will start the complete EPIC psychoeducational skills training intervention, held via Zoom, immediately after Assessment 2. Following completion of the 7 EPIC sessions, participants will attend monthly booster sessions, held via Zoom, to reinforce the skills/lessons. Participants may voluntarily choose to continue attending booster sessions through 2024.

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Who is running the clinical trial?

Arizona State UniversityLead Sponsor
283 Previous Clinical Trials
109,194 Total Patients Enrolled
David W. Coon, PhDPrincipal InvestigatorArizona State University

Media Library

EPIC: An Intervention for Early-stage AD Dyads - Adapted for Virtual Delivery (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03144921 — N/A
Alzheimer's Disease Research Study Groups: EPIC B (WLC), EPIC A
Alzheimer's Disease Clinical Trial 2023: EPIC: An Intervention for Early-stage AD Dyads - Adapted for Virtual Delivery Highlights & Side Effects. Trial Name: NCT03144921 — N/A
EPIC: An Intervention for Early-stage AD Dyads - Adapted for Virtual Delivery (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03144921 — N/A

Frequently Asked Questions

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~0 spots leftby May 2024