Early-Stage Partner in Care Living Alone Plus

Official title

Early-Stage Partner in Care-Living Alone (EPIC-LA)

Overview

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.

Interventions

• Behavioral Psychoeducational 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.

Primary outcome measures

• Quality of Life in Alzheimer's Disease (QoL-AD) [Time frame: Baseline, at 3 months, and at 6 months]
• UCLA 3-item Loneliness Scale [Time frame: Baseline, at 3 months, and at 6 months]
• Dementia Quality of Life (DQoL)- Positive and Negative Feelings Affect Scale [Time frame: Baseline, at 3 months, and at 6 months]
• Center of Epidemiologic Studies-Depression short form (CES-D) [Time frame: Baseline, at 3 months, and at 6 months]
• Hopkins Symptoms Checklist - Anger Subscale [Time frame: Baseline, at 3 months, and at 6 months]

Secondary outcome measures (7)

• 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]

Eligibility criteria

Early-stage inclusion criteria

• Must be at least 60 years of age
• 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).
• The Early-stage individual must have a diagnosis of early-stage ADRD or have a Mini-Mental State Exam (MMSE) score:

• between 20-26 for those who have completed high school, or
• between 17-26\*, for those who have not completed high school, or
• 27 or higher with a confirmed diagnosis of early-stage dementia or MCI.
• Able to participate in EPIC-LA workshops via zoom

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Arizona State University — Phoenix

Identifiers

NCT: NCT06962111 · STUDY00020497 · 1P30AG086561

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗