Early-Stage Partner in Care Living Alone Plus

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorArizona State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: EPICLA+Experimental treatment 1 intervention
Group B: Wait List Control (WLC)Active comparator 1 intervention

Trial outcomes

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

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arizona State University

Lead sponsor

National Institute on Aging (NIA)

Collaborator