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

NCT03144921 | Completed

• 1 other identifier: STUDY00005510, STUDY00012907
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Alzheimer Disease; Memory Loss

Keywords

Early-stage Dementia; Early-stage Alzheimer's disease; Care partner; Caregivers; Caregiving

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Knowledge and Use of Services for People with Dementia and their Care Partners

  Assessments T1-T3 to be conducted over span of six months

• Communication Skills and Support within the Dyad

  Assessments T1-T3 to be conducted over span of six months

• EP and CP Care preparedness

  Assessments T1-T3 to be conducted over span of six months

Other Outcomes (1)

• Initial incremental cost effectiveness of EPIC compared with Wait List Comparison condition

  T1 - T2 Assessments (Baseline to 3 months)

Study Arms (2)

EPIC A

EXPERIMENTAL

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

EPIC B (WLC)

ACTIVE COMPARATOR

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

Interventions

psychoeducational skills training intervention BEHAVIORAL

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.

EPIC A; EPIC B (WLC)

Eligibility Criteria

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

You may qualify if:

• 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.
• Eligible dyad relationships include spouse, adult-child relationships (e.g., daughters), and other close friends and family members.
• 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.
• CPs must live with or have regular contact with the EP.
• EPs and CPs must reside in a community setting.
• Live at home rather than an institutional setting,
• Have a confirmed diagnosis of OR symptoms consistent with early-stage dementia
• Exhibit changes in memory as specified on the AD8 dementia screening tool.
• Have a Mini-Mental State Exam (MMSE)i score within a protocol-specified range.
• 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

You may not qualify if:

• Denying or not reporting any trouble with memory, based on self-report
• Normal cognition, based on score derived from screening tool
• If yes to BOTH:
• severe mental illness or developmental disability before the age of 45
• memory problems due to past head injury

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Nationwide Program Locations (Based at ASU Edson College of Nursing and Health Innovation)

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David W. Coon, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean, R.I.S.E. and Professor

Model Details: Dyads will be randomized (assigned by chance) to one of two groups: 10 EPIC A or 2) EPIC B (Wait List Control - WLC. Randomization with stratification by language preference (English vs. Spanish) and geographic setting will occur in sets of 4 to 8 (average 6) eligible dyads. The RCT ends at T2 with comparison of changes in outcomes between EPIC and WLC participants from Assessment 1 (baseline) to Assessment 2 (3 months post baseline). T2-T3 assessments will be used for within-group and maintenance of gains analyses from about 3 months to 6 months post baseline.

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 9, 2017
• Study Start: December 12, 2017
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)