Alzheimer Disease Clinical Trial
— LEADOfficial title:
LEADing Dementia End-of-Life Planning Conversations
Advance care planning is important for all adults, but perhaps even more so for the 5.7 million persons with Alzheimer's disease or related dementia (ADRD), due to the progressive and protracted cognitive deterioration associated with the disease process. In the context of ADRD, medical decision-making at the end of life is typically left to one's care partner, who often does not have the knowledge or confidence in their ability to make such decisions. This study will refine and evaluate a web-based platform, called the LEAD Intervention (Life-Planning in Early Alzheimer's and other Dementias), which is designed to help persons in the preclinical or early stage of ADRD engage in conversations about, document, and share their end-of-life values and preferences with a care partner, extended family members, and health care providers.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | June 30, 2027 |
Est. primary completion date | June 30, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: ADRD Pairs = 1 care recipient + 1 care partner, where: 1) The care recipient self-reports having subjective cognitive complaints indicative of the preclinical or early stage of ADRD and 2) The care partner self-identifies as a spouse, long-term partner, or adult child of the care recipient. Preclinical is defined as having self-reported subjective cognitive complaints, measured using the Alzheimer's Association's "10 Warning Signs" checklist (participants must self-report having at least one warning sign), or self-report of having received a diagnosis of "mild cognitive impairment" (MCI) from a health care provider. Early Stage is defined by the criteria outlined by the Alzheimer's Association. In the early stage, a person may be able to function independently but is aware that he or she is having memory lapses, such as forgetting words or locations of everyday objects. Persons close to the individual with memory loss may notice changes, such as trouble coming up with the right word or name, trouble remembering names when introduced to new people, difficulty performing social or work tasks, forgetting information that he or she just read, misplacing objects, and trouble with planning or organizing. Exclusion Criteria: Previous engagement in advance care planning (defined as the completion of a medical advance directive for the care recipient). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Utah | National Institute on Aging (NIA) |
Dassel K, Utz R, Supiano K, Bybee S, Iacob E. Development of a Dementia-Focused End-of-Life Planning Tool: The LEAD Guide (Life-Planning in Early Alzheimer's and Dementia). Innov Aging. 2019 Aug 2;3(3):igz024. doi: 10.1093/geroni/igz024. eCollection 2019 Jul. — View Citation
Dassel KB, Utz R, Supiano K, McGee N, Latimer S. The Influence of Hypothetical Death Scenarios on Multidimensional End-of-Life Care Preferences. Am J Hosp Palliat Care. 2018 Jan;35(1):52-59. doi: 10.1177/1049909116680990. Epub 2016 Dec 17. — View Citation
Supiano KP, McGee N, Dassel KB, Utz R. A Comparison of the Influence of Anticipated Death Trajectory and Personal Values on End-of-Life Care Preferences: A Qualitative Analysis. Clin Gerontol. 2019 May-Jun;42(3):247-258. doi: 10.1080/07317115.2017.1365796. Epub 2017 Oct 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decision-Making Self-Efficacy | Decision-making efficacy as measured by both the care recipient and care partner as measured by the Family Decision-Making Self-Efficacy Scale | Week 20 | |
Secondary | Relationship Quality | Relationship quality as measured by both the care recipient and care partner as measured by the Dyadic Relationship Scale (DRS) | Week 20 | |
Secondary | Anxiety | Perceived symptoms of anxiety by both the care recipient and care partner as measured by the PROMIS Emotional Distress-Anxiety-Short Form 8a | Week 20 | |
Secondary | Subjective well-being | Perceived subjective well being of care recipient and care partner as measured by the PROMIS General Life Satisfaction- Short Form 5a | Week 20 |
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