Early-Stage Partner in Care Living Alone Plus

NCT06962111 | Recruiting DMC

• 2 other identifiers: STUDY000204971P30AG086561
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Mild Cognitive Impairment (MCI); Alzheimer Disease; Dementia

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Quality of Life in Alzheimer's Disease (QoL-AD)

  This scale assesses 13 global items of quality of life covering areas like physical health, mood, family, and finances, with the outcomes poor, fair, good, and excellent. It can be used across different dementia stages and is designed for individuals with dementia and their caregivers. The scale consists of 13 questions. Each question has four possible responses - poor, fair, good, and excellent, each equating to 1-4 points respectively. The total score ranges from 13 to 52, with higher scores indicating a higher quality of life.

  Baseline, at 3 months, and at 6 months

• UCLA 3-item Loneliness Scale

  This scale comprises three questions that measure three dimensions of loneliness: relational connectedness, social connectedness, and self-perceived isolation. The scale is rated with hardly ever, some of the time, and often, with scores ranging from 1 to 3, respectively. The total score ranges from 3 to 9, with scores ranging from 6 to 9 indicating loneliness.

  Baseline, at 3 months, and at 6 months

• Dementia Quality of Life (DQoL)- Positive and Negative Feelings Affect Scale

  The DQoL consists of 30 items and five scales: positive affect (six items), negative affect (11 items), feelings of belonging (three items), self-esteem (four items), sense of aesthetics (five items) and one global item. QDOL is a Likert scale with the outcomes never, seldom, sometimes, often, and very often, ranging from 1 to 5, respectively. Higher scores indicate better QoL, except on the negative affect scale. The study focuses on assessing positive (e.g., content) and negative (e.g., afraid) feelings.

  Baseline, at 3 months, and at 6 months

• Center of Epidemiologic Studies-Depression short form (CES-D)

  Shortened version of the CESD-20. It measures depressive symptoms and assesses feelings such as feeling bothered by things, having trouble concentrating, etc. It is scored by summing the responses to its 10 items, each rated on a 4-point scale with scores rarely or none of the time, some of the time, occasionally, and most of the time, ranging from 0 to 3, respectively. Total scores range from 0 to 30, with higher scores indicating greater depressive symptoms.

  Baseline, at 3 months, and at 6 months

• Hopkins Symptoms Checklist - Anger Subscale

  Tool used for assessing feelings, such as feeling critical of others, irritated, tense, calm, etc., using the Likert scale not at all, a little, somewhat, and very much with scores ranging from 0 to 3 respectively. higher scores indicate higher levels of anger.

  Baseline, at 3 months, and at 6 months

Secondary Outcomes (7)

• Care Preparedness Scale

  Baseline, at 3 months, and at 6 months

• Leisure Satisfaction Scale

  Baseline, at 3 months, and at 6 months

• Knowledge of Dementia (modified)

  Baseline, at 3 months, and at 6 months

• Care preferences/circle diagrams

  Baseline, at 3 months, and at 6 months

• Decision-making in daily and long-term care

  Baseline, at 3 months, and at 6 months

Other Outcomes (3)

• Mini-Mental State Examination (MMSE)

  Baseline, at 3 months, and at 6 months

• Socio-demographics

  Screening and baseline

• Perception of benefits and acceptability

  At 3 months or at 6 months

Study Arms (2)

EPICLA+

EXPERIMENTAL

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.

Behavioral: Psychoeducational skills training intervention

Wait List Control (WLC)

ACTIVE COMPARATOR

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

Behavioral: Psychoeducational skills training intervention

Interventions

Psychoeducational skills training intervention BEHAVIORAL

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.

EPICLA+; Wait List Control (WLC)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 60 years of age
• Must be able to participate in English or Spanish
• Must be a US resident
• Must be able to provide consent verbally and in writing (electronically or via mail)
• 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).
• The Early-stage individual must have a diagnosis of early-stage ADRD or have a Mini-Mental State Exam (MMSE) score:
• between 20-26 for those who have completed high school, or
• between 17-26\*, for those who have not completed high school, or
• or higher with a confirmed diagnosis of early-stage dementia or MCI.
• Able to participate in EPIC-LA workshops via zoom

You may not qualify if:

• Inability to participate via telephone or online video conferencing service.
• The participant expresses feelings of not wanting to participate
• The participant do not have enough time to attend the training,
• The participant demonstrates lack of skills with using a computer that precludes participation
• The participant does not have a stable internet connection to connect to the video platform
• The participant has difficulty hearing or a visual impairment that precludes participation.

Sponsors & Collaborators

• Arizona State University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

RECRUITING

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Alzheimer Disease; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Gomez-Morales

  ASU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Gomez-Morales, PhD

CONTACT

602-543-6672; agomezm1@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: May 8, 2025
• Study Start: March 26, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)