EPIC: An Intervention for Early-stage AD Dyads - Adapted for Virtual Delivery

EPIC: A Group-based Intervention for Early-stage AD Dyads in Diverse Communities

EPIC II (Early-Stage Partners in Care) is a research project designed to assist people with early-stage memory loss and their care partners by providing early-stage related education and skill-training sessions, held via Zoom, designed to reduce stress, enhance well-being, manage challenges, and plan for the future. Researchers will gather feedback from individuals about their experience to continue to improve programs for early-stage memory loss.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Alzheimer Disease; Memory Loss
• Intervention / Treatment: Behavioral: psychoeducational skills training intervention

Detailed Description

The purpose of this study is to help early-stage individuals who have early-stage memory loss or early stage dementia and their current or future care partners by providing education and skill-training programs, held via Zoom, designed to reduce stress and distress, increase well-being and quality of life, and plan for the future. About 160 early-stage dyads (person with early-stage dementia and his/her care partner) will be enrolled across the United States through Arizona State University.

People who decide to voluntarily participate in this program, will be asked to:

• Meet others with memory loss and their care partners.
• Attend six group sessions via Zoom (2 hours & 30 minutes each) to learn strategies to help handle new situations, reduce stress, improve mood, communicate better with each other, and plan for the future.
• Participate in one 90-minute individualized session via Zoom to address specific issues that may be unique to each dyad's situation.
• Participate in three 2-hour confidential interviews that involve questions about background, mood, and quality of life.
• Participate in interviews at the start, and again about 3 and 6 months, via Zoom, to help us to continue to improve the program.
• Attend several monthly booster sessions after completion of the seven EPIC sessions.

Each person will receive up to $45 for completing all follow-up interviews, or $20- 25 for each interview completed. All participants are offered the EPIC sessions shortly after their first interview or shortly after their 3-month interview. Some participants will also attend an additional free education workshop within one month of the initial assessment.

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Coon Research Team; Phone Number: 602-496-1239; Email: coonresearch@asu.edu
• Study Contact Backup: Name: Allison Glinka, MASGIS; Phone Number: 602-496-1239; Email: allison.glinka@asu.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • Nationwide Program Locations (Based at ASU Edson College of Nursing and Health Innovation)
      • Principal Investigator: David W. Coon, PhD
      • Contact: Allison Glinka, MASGIS; Email: allison.glinka@asu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

DYAD INCLUSION CRITERIA:

1. 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.
2. Eligible dyad relationships include spouse, adult-child relationships (e.g., daughters), and other close friends and family members.
3. Care partners must self-identify as the person who currently has or who expects to have the most hands-on responsibility and ongoing involvement with the EP.
4. CPs must live with or have regular contact with the EP.
5. EPs and CPs must reside in a community setting.

EP INCLUSION CRITERIA:

1. Live at home rather than an institutional setting,
2. Have a confirmed diagnosis of OR symptoms consistent with early-stage dementia
3. Exhibit changes in memory as specified on the AD8 dementia screening tool.
4. Have a Mini-Mental State Exam (MMSE)i score within a protocol-specified range.
5. Have a CP who is defined by the EP as being the unpaid "family member" who has or will have primary responsibility for providing assistance to the EP

EP EXCLUSION CRITERIA:

1. Denying or not reporting any trouble with memory, based on self-report
2. Normal cognition, based on score derived from screening tool

3. If yes to BOTH:

   1. severe mental illness or developmental disability before the age of 45
   2. memory problems due to past head injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EPIC A; 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.	Behavioral: psychoeducational skills training intervention; This protocol is a minimal risk care values clarification /care planning and psychoeducational skills training intervention, delivered as a workshop series plus one in-home session for people in the early stages of memory loss and their care partner together.
Active Comparator: EPIC B (WLC); 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.	Behavioral: psychoeducational skills training intervention; This protocol is a minimal risk care values clarification /care planning and psychoeducational skills training intervention, delivered as a workshop series plus one in-home session for people in the early stages of memory loss and their care partner together.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EP and CP Emotional well-being	Examine the efficacy of the EPIC intervention as compared with a Wait List Comparison condition by looking at the change over time in the Positive and Negative Affect Scales (Dementia Quality of Life Instrument).	Assessments T1-T3 to be conducted over span of six months
EP Quality of Life	Assess EP Quality of life and CPs perception of EPs Quality of life by looking at the change over time in the Quality of Life Measure in Dementia.	Assessments T1-T3 to be conducted over span of six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge and Use of Services for People with Dementia and their Care Partners	Assess the knowledge of, use of, and satisfaction with a variety of services (for example, respite, support groups, case management, referral services) relevant to people with dementia and their care partners by looking at the change over time.	Assessments T1-T3 to be conducted over span of six months
Communication Skills and Support within the Dyad	Assess communication by looking at the change over time in the Dyadic Relationship Scale and Emotional Intimacy Disruptive Behavior Scale.	Assessments T1-T3 to be conducted over span of six months
EP and CP Care preparedness	Assess EP and CP perceptions of how well prepared they feel for addressing future care needs by looking at the change over time in the Care Partners Preparedness Scale (modified).	Assessments T1-T3 to be conducted over span of six months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial incremental cost effectiveness of EPIC compared with Wait List Comparison condition	Based on Quality of Life Adjusted Years for the EPs and hours providing care for CPs, conduct a cost benefit analysis to explicitly indicate whether benefits of the EPIC program outweigh costs by looking at the change over time.	T1 - T2 Assessments (Baseline to 3 months)

Collaborators and Investigators

• Sponsor: Arizona State University
• Investigators: Principal Investigator: David W. Coon, PhD, Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Caregivers; Caregiving; Early-stage Dementia; Early-stage Alzheimer's disease; Care partner
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease; Memory Disorders
• Other Study ID Numbers: STUDY00005510, STUDY00012907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No