Early-Stage Partner in Care Living Alone Plus (EPICLA+)

Arizona State University (ASU)

Status: Enrolling

Conditions: Mild Cognitive Impairment (MCI); Alzheimer Disease; Dementia

Treatments: Behavioral: Psychoeducational skills training intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06962111

1P30AG086561 (U.S. NIH Grant/Contract)

STUDY00020497

Details and patient eligibility

About

EPICLA+ (Early-Stage Partners in Care Living Alone Plus) is a research project designed to assist people with early-stage memory loss who live alone in the community 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.

Full description

This study aims to create a supportive environment to help individuals with early-stage memory loss or early-stage dementia living alone in the community by providing education and skill-training programs, held via Zoom, where they can be educated in memory changes associated with dementia, learn to manage behavioral changes, improve communication skills, cope with stress, and plan for the future. About 70 people will be enrolled across the United States through Arizona State University.

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

Meet others in the earlier stages of memory loss who live alone Attend six group sessions via Zoom (2 hours and 30 minutes each) to learn strategies for handling new situations, reducing stress, improving mood, communicating better with others, and planning for the future.

Participate in one 90-minute individualized session via Zoom to address specific issues unique to each one's situation.

Participate in three 2-hour confidential interviews that involve questions about background, mood, and quality of life.

Participate in a booster session for those initially assigned to EPICLA+, lasting approximately 90 minutes.

Participate in interviews at the start, and again about 3 and 6 months, via Zoom, to help us continue to improve the program.

All participants are offered the EPICLA+ sessions shortly after their first interview or shortly after their 3-month interview.

Enrollment: 70 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Early-stage inclusion criteria

1. Must be at least 60 years of age

2. Must be able to participate in English or Spanish

3. Must be a US resident

4. Must be able to provide consent verbally and in writing (electronically or via mail)

5. Must exhibit at least 2 of 8 changes caused by thinking and memory problems on the AD8 (a reliable and valid 8-item dementia screening tool).

6. The Early-stage individual must have a diagnosis of early-stage ADRD or have a Mini-Mental State Exam (MMSE) score:

   1. between 20-26 for those who have completed high school, or
   2. between 17-26*, for those who have not completed high school, or
   3. 27 or higher with a confirmed diagnosis of early-stage dementia or MCI.

7. Able to participate in EPIC-LA workshops via zoom

   Exclusion Criteria:

8. Inability to participate via telephone or online video conferencing service.

9. The participant expresses feelings of not wanting to participate

10. The participant do not have enough time to attend the training,

11. The participant demonstrates lack of skills with using a computer that precludes participation

12. The participant does not have a stable internet connection to connect to the video platform

13. The participant has difficulty hearing or a visual impairment that precludes participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

EPICLA+

Experimental group

Description:

Group EPICLA+ will start the intervention immediately after assessment 1. The EPICLA+ program consists of a 7-session, psychoeducational skills training intervention, held via Zoom, designed to assist people with early-stage memory loss that live alone in the community by providing early-stage-related education and skill-training sessions to reduce stress, enhance well-being, manage challenges, and plan for the future. Following the 7 EPIC sessions, participants will attend a booster session, held via Zoom, to reinforce the skills/lessons.

Treatment:

Behavioral: Psychoeducational skills training intervention

Wait List Control (WLC)

Active Comparator group

Description:

The WLC group will start the intervention after 3 months of the EPICLA+ group start date, once T2 assessment is completed.

Treatment:

Behavioral: Psychoeducational skills training intervention