Recruiting

Observational Study

Sponsor:

Arizona State University

Code:

NCT06962111

Conditions

Dementia

Mild Cognitive Impairment (MCI)

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Psychoeducational skills training intervention

Study Details

Brief summary:

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.

Conditions

Dementia

Mild Cognitive Impairment (MCI)

Alzheimer Disease

Study ID

NCT06962111

Start date

Mar 26, 2025

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EPICLA+

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.

active comparator: Wait List Control (WLC)

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

Interventions

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 who live alone. In addition, during this intervention, participants will have access to general and personalized virtual resources with materials for use during and after the intervention.

Primary outcome measure

  • Quality of Life in Alzheimer's Disease (QoL-AD) [ Time Frame: Baseline, at 3 months, and at 6 months ]
  • UCLA 3-item Loneliness Scale [ Time Frame: Baseline, at 3 months, and at 6 months ]
  • Dementia Quality of Life (DQoL)- Positive and Negative Feelings Affect Scale [ Time Frame: Baseline, at 3 months, and at 6 months ]
  • Center of Epidemiologic Studies-Depression short form (CES-D) [ Time Frame: Baseline, at 3 months, and at 6 months ]
  • Hopkins Symptoms Checklist - Anger Subscale [ Time Frame: Baseline, at 3 months, and at 6 months ]

Central Contacts and Locations

Central contacts

Dr. Gomez-Morales, PhD

602-543-6672agomezm1@asu.edu

Locations

Arizona State University

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Dr. Gomez-Morales

844-418-5538agingsuccessfully@asu.edu

More Information

Sponsor

Arizona State University

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Living Alone
  • Memory Disorders
  • Older adults (60 years and older)
  • Alzheimer Disease and Related Dementias
  • Early Stage Alzheimer disease
  • Intervention
  • Skill-building

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arizona State University on 2026-03-27.