[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06962111":3,"trial-entities:NCT06962111":121,"trial-summary:NCT06962111":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":45,"secondary_outcomes":62,"sex":84,"minimum_age":85,"maximum_age":86,"healthy_volunteers":87,"eligibility_criteria":88,"std_ages":92,"locations":95,"central_contacts":110,"overall_officials":115,"references":119,"see_also_links":120},"NCT06962111","STUDY00020497","Early-Stage Partner in Care Living Alone Plus","Early-Stage Partner in Care-Living Alone (EPIC-LA)","RECRUITING","2027-03","2026-03","2026-03-27","2025-03-26","Arizona State University","OTHER",true,"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.","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.\n\nPeople who decide to participate in this program voluntarily will be asked to:\n\nMeet 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.\n\nParticipate in one 90-minute individualized session via Zoom to address specific issues unique to each one's situation.\n\nParticipate in three 45-minute confidential interviews that involve questions about background, mood, and quality of life.\n\nParticipate in a booster session for those initially assigned to EPICLA+, lasting approximately 2h 30 minutes.\n\nParticipate in interviews at the start, and again about 3 and 6 months, via Zoom, to help us continue to improve the program.\n\nAll participants are offered the EPICLA+ sessions shortly after their first interview or shortly after their 3-month interview.",[19,20,21],"Dementia","Mild Cognitive Impairment (MCI)","Alzheimer Disease",[23,24,25,26,27,28,29],"Living Alone","Memory Disorders","Older adults (60 years and older)","Alzheimer Disease and Related Dementias","Early Stage Alzheimer disease","Intervention","Skill-building","INTERVENTIONAL","TREATMENT",[33],"NA",{"count":35,"type":36},70,"ESTIMATED",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42},"BEHAVIORAL","Psychoeducational skills training intervention","This protocol is a minimal risk care values clarification \u002Fcare 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.",[43,44],"EPICLA+","Wait List Control (WLC)",[46,50,53,56,59],{"measure":47,"description":48,"timeFrame":49},"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.","Baseline, at 3 months, and at 6 months",{"measure":51,"description":52,"timeFrame":49},"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.",{"measure":54,"description":55,"timeFrame":49},"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.",{"measure":57,"description":58,"timeFrame":49},"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.",{"measure":60,"description":61,"timeFrame":49},"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.",[63,66,69,72,75,78,81],{"measure":64,"description":65,"timeFrame":49},"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.",{"measure":67,"description":68,"timeFrame":49},"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.",{"measure":70,"description":71,"timeFrame":49},"Knowledge of Dementia (modified)","Assessment of the knowledge and understanding of dementia, causes, course, and treatment. Answers are true or false.",{"measure":73,"description":74,"timeFrame":49},"Care preferences\u002Fcircle diagrams","Peferences for who (informal or paid help) assist with care. Choices are: care partner, family\u002Ffriends and Paid helper.",{"measure":76,"description":77,"timeFrame":49},"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.",{"measure":79,"description":80,"timeFrame":49},"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.",{"measure":82,"description":83,"timeFrame":49},"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.","ALL","60 Years",null,false,{"inclusion":89,"exclusion":90,"raw_text":91},[],[],"Early-stage inclusion criteria\n\n1. Must be at least 60 years of age\n2. Must be able to participate in English or Spanish\n3. Must be a US resident\n4. Must be able to provide consent verbally and in writing (electronically or via mail)\n5. 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).\n6. The Early-stage individual must have a diagnosis of early-stage ADRD or have a Mini-Mental State Exam (MMSE) score:\n\n   1. between 20-26 for those who have completed high school, or\n   2. between 17-26\\*, for those who have not completed high school, or\n   3. 27 or higher with a confirmed diagnosis of early-stage dementia or MCI.\n7. Able to participate in EPIC-LA workshops via zoom\n\n   Exclusion Criteria:\n8. Inability to participate via telephone or online video conferencing service.\n9. The participant expresses feelings of not wanting to participate\n10. The participant do not have enough time to attend the training,\n11. The participant demonstrates lack of skills with using a computer that precludes participation\n12. The participant does not have a stable internet connection to connect to the video platform\n13. The participant has difficulty hearing or a visual impairment that precludes participation.",[93,94],"ADULT","OLDER_ADULT",[96],{"facility":13,"status":8,"city":97,"state":98,"zip":99,"country":100,"contacts":101,"geoPoint":107},"Phoenix","Arizona","85004","United States",[102],{"name":103,"role":104,"phone":105,"email":106},"Dr. Gomez-Morales","CONTACT","844-418-5538","agingsuccessfully@asu.edu",{"lat":108,"lon":109},33.44838,-112.07404,[111],{"name":112,"role":104,"phone":113,"email":114},"Dr. Gomez-Morales, PhD","602-543-6672","agomezm1@asu.edu",[116],{"name":103,"affiliation":117,"role":118},"ASU","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":122,"biomarkers":125},[123,19,124],"Alzheimer's Disease","Mild cognitive disorder",[],{"nct_id":4,"found":15,"summary":127,"prompt_version":137},{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is an interventional study with about 70 participants. It is not specified if it is randomized or blinded.","completed","EPICLA+ for Early-Stage Memory Loss","This study, called EPICLA+, is for people aged 60 and older with early-stage memory loss, mild cognitive impairment (MCI), or Alzheimer's disease who live alone. It tests a psychoeducational skills training intervention, delivered through Zoom workshops and one in-home session. The goal is to help you manage challenges, reduce stress, and plan for the future. Researchers will measure your quality of life and feelings of loneliness at the start, and again at 3 and 6 months, to see if the program is helpful. This study is currently unclear regarding its recruitment status and plans to enroll about 70 participants.","You will be followed for about 6 months after the start of the program.",99,"You would attend six 2.5-hour group sessions via Zoom, one 90-minute individual Zoom session, and three 45-minute confidential interviews. You would also participate in a booster session and interviews at the start, 3 months, and 6 months.","Not stated in the trial record.",[40],"v2"]