Early-Stage Partner in Care Living Alone Plus

Not Applicable

Recruiting

• Conditions: Dementia; Mild Cognitive Impairment (MCI); Alzheimer Disease

• Registration Number: NCT06962111
• Lead Sponsor: Arizona State University

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 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 Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-26
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-04-29
• Study First Posted: 2025-05-08
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-06
• Primary Completion: 2026-03
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of Life in Alzheimer's Disease (QoL-AD)	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	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	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)	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	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.

Secondary Outcome Measures

Name	Time	Method
Care Preparedness Scale	Baseline, at 3 months, and at 6 months	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.
Leisure Satisfaction Scale	Baseline, at 3 months, and at 6 months	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.
Knowledge of Dementia (modified)	Baseline, at 3 months, and at 6 months	Assessment of the knowledge and understanding of dementia, causes, course, and treatment. Answers are true or false.
Care preferences/circle diagrams	Baseline, at 3 months, and at 6 months	Peferences for who (informal or paid help) assist with care. Choices are: care partner, family/friends and Paid helper.
Decision-making in daily and long-term care	Baseline, at 3 months, and at 6 months	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.
Emotional-Intimacy Disruptive Behavior Scale	Baseline, at 3 months, and at 6 months	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.
Dementia Quality of life Instrument- self-esteem subscale	Baseline, at 3 months, and at 6 months	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.

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States