Arizona State University
Phoenix, Arizona, 85004, United States
Location status: Recruiting
NCT Number: NCT06962111
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Phoenix, Arizona, 85004, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Early-stage inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, at 3 months, and at 6 months
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: Screening and baseline
Socio-demographics characteristics questions (e.g., level of education, marital status).
Time frame: At 3 months or at 6 months
Perceived study benefits questions (e.g., How much do you think you benefitted from participating in EPIC Living Alone Plus?)
Contact information is provided by the study sponsor or research team.
Arizona State University
Other
Early-Stage Partner in Care-Living Alone (EPIC-LA)
Acronym: EPICLA+
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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