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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03144921
• Other study ID #: STUDY00005510, STUDY00012907
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2017
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: Arizona State University
• Contact: Coon Research Team
• Phone: 602-496-1239
• Email: coonresearch[@]asu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Memory Disorders
• Memory Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Nationwide Program Locations (Based at ASU Edson College of Nursing and Health Innovation)	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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
Primary	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	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
Secondary	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
Secondary	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