Clinical trial NCT06962111: Early-Stage Partner in Care Living Alone Plus
Official title: Early-Stage Partner in Care-Living Alone (EPIC-LA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Mild Cognitive Impairment (MCI)
Alzheimer Disease
Keywords: Living Alone
Memory Disorders
Older adults (60 years and older)
Alzheimer Disease and Related Dementias
Early Stage Alzheimer disease
Intervention
Skill-building
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-05-08
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized (assigned by chance) to one of two groups: 1) EPICLA+ or 2) Wait List Control (WLC).

The WLC group is offered EPICLA+ after the T2. For the WLC, comparing their T2 and T3 assessments provides an opportunity to examine within-person change before and after receiving the EPICLA+ intervention. For those assignments at T1 to EPIC LA+, follow-ups between T2 and T3 provide opportunities to examine maintenance of gains.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Quality of Life in Alzheimer's Disease (QoL-AD)
timeFrame: Baseline, at 3 months, and at 6 months
measure: UCLA 3-item Loneliness Scale
timeFrame: Baseline, at 3 months, and at 6 months
measure: Dementia Quality of Life (DQoL)- Positive and Negative Feelings Affect Scale
timeFrame: Baseline, at 3 months, and at 6 months
measure: Center of Epidemiologic Studies-Depression short form (CES-D)
timeFrame: Baseline, at 3 months, and at 6 months
measure: Hopkins Symptoms Checklist - Anger Subscale
timeFrame: Baseline, at 3 months, and at 6 months
Secondary outcomes:
measure: Care Preparedness Scale
timeFrame: Baseline, at 3 months, and at 6 months
measure: Leisure Satisfaction Scale
timeFrame: Baseline, at 3 months, and at 6 months
measure: Knowledge of Dementia (modified)
timeFrame: Baseline, at 3 months, and at 6 months
measure: Care preferences/circle diagrams
timeFrame: Baseline, at 3 months, and at 6 months
measure: Decision-making in daily and long-term care
timeFrame: Baseline, at 3 months, and at 6 months
measure: Emotional-Intimacy Disruptive Behavior Scale
timeFrame: Baseline, at 3 months, and at 6 months
measure: Dementia Quality of life Instrument- self-esteem subscale
timeFrame: Baseline, at 3 months, and at 6 months
Other outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: Baseline, at 3 months, and at 6 months
measure: Socio-demographics
timeFrame: Screening and baseline
measure: Perception of benefits and acceptability
timeFrame: At 3 months or at 6 months
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: ASU
name: Dr. Gomez-Morales
role: PRINCIPAL_INVESTIGATOR
References: