Clinical trial NCT03144921: EPIC: An Intervention for Early-stage AD Dyads - Adapted for Virtual Delivery
Official title: EPIC: A Group-based Intervention for Early-stage AD Dyads in Diverse Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Memory Loss
Keywords: Early-stage Dementia
Early-stage Alzheimer's disease
Care partner
Caregivers
Caregiving
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: EP and CP Emotional well-being
timeFrame: Assessments T1-T3 to be conducted over span of six months
measure: EP Quality of Life
timeFrame: Assessments T1-T3 to be conducted over span of six months
Secondary outcomes:
measure: Knowledge and Use of Services for People with Dementia and their Care Partners
timeFrame: Assessments T1-T3 to be conducted over span of six months
measure: Communication Skills and Support within the Dyad
timeFrame: Assessments T1-T3 to be conducted over span of six months
measure: EP and CP Care preparedness
timeFrame: Assessments T1-T3 to be conducted over span of six months
Other outcomes:
measure: Initial incremental cost effectiveness of EPIC compared with Wait List Comparison condition
timeFrame: T1 - T2 Assessments (Baseline to 3 months)
Locations:
city: Phoenix
country: United States
facility: Nationwide Program Locations (Based at ASU Edson College of Nursing and Health Innovation)
state: Arizona
Study officials:
affiliation: Arizona State University
name: David W. Coon, PhD
role: PRINCIPAL_INVESTIGATOR
References: