ClinicalTrials.gg
RecruitingNCT06962111EPICLA+Updated Mar 27, 2026

Early-Stage Partner in Care Living Alone Plus

An interventional study of Psychoeducational skills training intervention in Dementia, Mild Cognitive Impairment (MCI) and Alzheimer Disease, sponsored by Arizona State University. Recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Primary conditionAlzheimer DiseaseRegistry: DementiaReclassifiedWhy we changed it
Registry
Dementia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Alzheimer Disease
Why
  1. The study's listed conditions name Alzheimer Disease, a narrower term within Dementia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Arizona State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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 45-minute 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 2h 30 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.

02

Conditions studied

  • Dementia
  • Mild Cognitive Impairment (MCI)
  • Alzheimer Disease

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Keywords

  • Living Alone
  • Memory Disorders
  • Older adults (60 years and older)
  • Alzheimer Disease and Related Dementias
  • Early Stage Alzheimer disease
  • Intervention
  • Skill-building
03

In context

Alzheimer Disease Reclassified

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 70 is close to the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.

Compared within Alzheimer Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dementia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study 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.

    Behavioral: Psychoeducational skills training intervention

  • 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.

    Behavioral: Psychoeducational skills training intervention

Interventions

  • BehavioralPsychoeducational 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, at 3 months, and at 6 months

  2. 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.

    Time frame: Baseline, at 3 months, and at 6 months

  3. 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.

    Time frame: Baseline, at 3 months, and at 6 months

  4. 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.

    Time frame: Baseline, at 3 months, and at 6 months

  5. 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.

    Time frame: Baseline, at 3 months, and at 6 months

Secondary outcomes

  1. Care Preparedness Scale

    Assessment of the level of preparedness associated with future care using the Likert scale: not at all prepared, not too well prepared, somewhat well prepared, pretty well prepared, and very well prepared. Scores range from 1 to 5. Higher scores indicate higher levels of care preparedness.

    Time frame: Baseline, at 3 months, and at 6 months

  2. Leisure Satisfaction Scale

    Assessment of the diligence in one's own health and leisure activity satisfaction using the ratings not at all, a little, and a lot. Scores range from 1 to 3, respectively, with higher scores indicating higher levels of leisure satisfaction and diligence in one's own health.

    Time frame: Baseline, at 3 months, and at 6 months

  3. Knowledge of Dementia (modified)

    Assessment of the knowledge and understanding of dementia, causes, course, and treatment. Answers are true or false.

    Time frame: Baseline, at 3 months, and at 6 months

  4. Care preferences/circle diagrams

    Peferences for who (informal or paid help) assist with care. Choices are: care partner, family/friends and Paid helper.

    Time frame: Baseline, at 3 months, and at 6 months

  5. Decision-making in daily and long-term care

    Discussion with others on daily and future care options. The answers to the choices are like it very much, like it somewhat, dislike it somewhat, dislike it very much, and don't know.

    Time frame: Baseline, at 3 months, and at 6 months

  6. Emotional-Intimacy Disruptive Behavior Scale

    Assessment of the degree of communication and openness with others. Respondents rate the extent to which they engaged in the behavior using the ratings none of the time, some of the time, much of the time, and most or all of the time. Scores range from 1 to 5, respectively, with higher scores indicating higher engagement in disruptive behavior.

    Time frame: Baseline, at 3 months, and at 6 months

  7. Dementia Quality of life Instrument- self-esteem subscale

    A subscale specifically designed to assess the level of confidence, accomplishment, and decision-making in people with dementia. The assessment is measured with the outcomes never, seldom, sometimes, often, and very often, with scores ranging from 1 to 5, respectively, with higher scores indicating higher levels of confidence.

    Time frame: Baseline, at 3 months, and at 6 months

Other outcomes

  1. Mini-Mental State Examination (MMSE)

    Gives a brief assessment of mental state status. It assesses different aspects of cognitive function, including orientation, memory, language, and visuospatial skills through different activities. The test is scored out of 30, with lower scores indicating more significant cognitive impairment.

    Time frame: Baseline, at 3 months, and at 6 months

  2. Socio-demographics

    Socio-demographics characteristics questions (e.g., level of education, marital status).

    Time frame: Screening and baseline

  3. Perception of benefits and acceptability

    Perceived study benefits questions (e.g., How much do you think you benefitted from participating in EPIC Living Alone Plus?)

    Time frame: At 3 months or at 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Mar 2027, 24 months after the start.

Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 24 months is below that.

Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2025
First posted
May 8, 2025
StartActual
Mar 26, 2025
Primary completionEst.
Mar 2027
CompletionEst.
Mar 2027
Last update
Mar 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06962111
Responsible party
Abigail Gomez Morales (Assistant Professor, Arizona State University) — Principal investigator
First posted
May 8, 2025
Start date
Mar 26, 2025
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Mar 27, 2026

Study contacts

Dr. Gomez-Morales, PhD
Contact
agomezm1@asu.edu
602-543-6672
Dr. Gomez-Morales
principal investigator · ASU

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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