DementiaEPICLA+NCT06962111
Early-Stage Partner in Care Living Alone Plus
A study testing Psychoeducational skills training intervention in people with Dementia and Mild Cognitive Impairment (MCI), run by Arizona State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Mild Cognitive Impairment (MCI), Alzheimer Disease
- What is being tested?
- Psychoeducational skills training intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Arizona State University
Phoenix, Arizona, 85004
Dr. Gomez-Morales, 844-418-5538, agingsuccessfully@asu.edu
About this study
Official title: Early-Stage Partner in Care-Living Alone (EPIC-LA)
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.
- Conditions
- Dementia, Mild Cognitive Impairment (MCI), Alzheimer Disease
- Being tested
- Psychoeducational skills training intervention
- Keywords
- Living Alone, Memory Disorders, Older adults (60 years and older), Alzheimer Disease and Related Dementias, Early Stage Alzheimer disease, Intervention, Skill-building
- Medical subject headings
- Dementia, Cognitive Dysfunction, Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational skills training interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychoeducational skills training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, at 3 months, and at 6 months
Secondary outcomes (7)
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.
Measured: Baseline, at 3 months, and at 6 months
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.
Measured: Baseline, at 3 months, and at 6 months
Knowledge of Dementia (modified)
Assessment of the knowledge and understanding of dementia, causes, course, and treatment. Answers are true or false.
Measured: Baseline, at 3 months, and at 6 months
Care preferences/circle diagrams
Peferences for who (informal or paid help) assist with care. Choices are: care partner, family/friends and Paid helper.
Measured: Baseline, at 3 months, and at 6 months
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.
Measured: Baseline, at 3 months, and at 6 months
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.
Measured: Baseline, at 3 months, and at 6 months
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.
Measured: Baseline, at 3 months, and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start26 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Abigail Gomez Morales, Arizona State University
- Investigators
- Dr. Gomez-Morales, Principal investigator, ASU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962111
- Sponsor's protocol ID
- STUDY00020497
- Other IDs
- 1P30AG086561
- Acronym
- EPICLA+
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-Stage Partner in Care-Living Alone (EPIC-LA)
- ClinicalTrials.gov ID
- NCT06962111
- Acronym / sponsor ID
- EPICLA+ / STUDY00020497
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| EPICLA+ | Experimental | Behavioral: Psychoeducational skills training interventionGroup 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. |
| Wait List Control (WLC) | Active comparator | Behavioral: Psychoeducational skills training interventionThe WLC group will start the intervention after 3 months of the EPICLA+ group start date, once T2 assessment is completed. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational skills training interventionThis 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. | Behavioural | EPICLA+, Wait List Control (WLC) |
Primary outcome
Quality of Life in Alzheimer's Disease (QoL-AD)
Time frame: Baseline, at 3 months, and at 6 months
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.
UCLA 3-item Loneliness Scale
Time frame: Baseline, at 3 months, and at 6 months
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.
Dementia Quality of Life (DQoL)- Positive and Negative Feelings Affect Scale
Time frame: Baseline, at 3 months, and at 6 months
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.
Center of Epidemiologic Studies-Depression short form (CES-D)
Time frame: Baseline, at 3 months, and at 6 months
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.
Hopkins Symptoms Checklist - Anger Subscale
Time frame: Baseline, at 3 months, and at 6 months
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.
7 secondary outcomes
Care Preparedness Scale
Time frame: Baseline, at 3 months, and at 6 months
Leisure Satisfaction Scale
Time frame: Baseline, at 3 months, and at 6 months
Knowledge of Dementia (modified)
Time frame: Baseline, at 3 months, and at 6 months
Care preferences/circle diagrams
Time frame: Baseline, at 3 months, and at 6 months
Decision-making in daily and long-term care
Time frame: Baseline, at 3 months, and at 6 months
Emotional-Intimacy Disruptive Behavior Scale
Time frame: Baseline, at 3 months, and at 6 months
Dementia Quality of life Instrument- self-esteem subscale
Time frame: Baseline, at 3 months, and at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Gomez-Morales principal investigator
ASU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational skills training intervention in people with Dementia and Mild Cognitive Impairment (MCI), run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Gomez-Morales, PhD (602-543-6672, agomezm1@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life in Alzheimer's Disease (QoL-AD) (time frame: Baseline, at 3 months, and at 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.