LEADing Dementia End-of-Life Planning Conversations

NCT ID: NCT05909189

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-04
• Study Completion Date: 2027-05-31

Brief Summary

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.

Detailed Description

Advance care planning is the process that allows individuals to express their future healthcare values and preferences so that these wishes can be enacted in the event that they become incapacitated and unable to participate in their own healthcare decisions. In the case of Alzheimer's disease or related dementia (ADRD), the person with dementia (care recipient), almost inevitably loses decisional capacity toward the end of life, given the progressive decline in cognitive functioning that accompanies the disease over time. The care partners to persons with dementia, most often family members such as spouse/partners and adult children, are therefore tasked with making end-of-life decisions on behalf of the care recipient with ADRD. These care partners are not always well-informed of the care recipient's end-of-life values and preferences and therefore may not feel confident in their ability to make decisions regarding care and treatment at the end-of-life, resulting in unnecessary, futile, and often unwanted medical treatments and interventions. Oftentimes, families do not want to engage in these challenging conversations and wait too long, whereby the care recipient with ADRD no longer has the decisional ability to participate in the advance care planning process. We developed "The LEAD Guide" (Life-Planning in Early Alzheimer's and other Dementias), as a tool to help persons with preclinical awareness of ADRD risk and those with early-stage cognitive impairment to begin these important conversations with a care partner. In this NIH Stage-1 behavioral intervention study we will refine the LEAD Intervention based on our pilot work (Stage 1A) and then evaluate the usability, acceptability, feasibility, and initial efficacy of the LEAD Intervention (Stage 1B). We will recruit a diverse sample of 60 community-dwelling ADRD pairs, defined as a care recipient in the preclinical or early stage of ADRD, plus their current or anticipated care partner (i.e., spouse/partner or adult child). Results are expected to show that the LEAD Intervention can improve outcomes related to decision-making self-efficacy through greater advance care planning congruence and improve subjective well-being, anxiety, and relationship quality as perceived and reported by both the care recipient and the care partner. Results from this study have the potential to guide and accelerate the implementation of the LEAD Intervention in community and healthcare practice, where a dementia-focused advance care process is needed.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ADRD dyads

This is a single-arm study enrolling 60 ADRD community-based dyads.

Group Type: EXPERIMENTAL

LEADing Dementia End-of-Life Planning Conversations

Intervention Type: OTHER

The LEAD Intervention is self-administered and delivered through an interactive, web-based platform designed according to recommended functionalities and user-designed principles. Through three distinct modules, the LEAD Intervention will facilitate the advance care planning processes of 1) defining care recipients' values and preferences for care, 2) developing advance care planning congruence within the pair, or a shared understanding of the care recipient's values and preferences, through conversation(s), and 3) encouraging ongoing advance care planning conversation and documentation that can be shared beyond the pair. All modules will include video tutorials to introduce the goals and tasks as well as provide interactive resources to provide support and education relevant to the content of each module. The three modules are intended to be followed in a sequential pattern.

Interventions

LEADing Dementia End-of-Life Planning Conversations

The LEAD Intervention is self-administered and delivered through an interactive, web-based platform designed according to recommended functionalities and user-designed principles. Through three distinct modules, the LEAD Intervention will facilitate the advance care planning processes of 1) defining care recipients' values and preferences for care, 2) developing advance care planning congruence within the pair, or a shared understanding of the care recipient's values and preferences, through conversation(s), and 3) encouraging ongoing advance care planning conversation and documentation that can be shared beyond the pair. All modules will include video tutorials to introduce the goals and tasks as well as provide interactive resources to provide support and education relevant to the content of each module. The three modules are intended to be followed in a sequential pattern.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Care Recipient (CR) is age 50+
• CR Is interested in having conversations about and documenting wishes for future end-of-life care
• CR has noticed changes in memory or thinking skills indicative of preclinical or early stage of AD, OR
• CR has been diagnosed with mild cognitive impairment, Alzheimer's disease, or another type of dementia and in the preclinical or early stage
• Care Partner (CP) is age 18+
• CP is a Spouse/partner, family member, or close friend of CR

Exclusion Criteria

• Has moderate to severe symptoms of dementia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Kara Dassel

Professor, Assistant Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kara Dassel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah College of Nursing

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kara Dassel, PhD

Role: CONTACT

kara.dassel@nurs.utah.edu

801-646-4667

Nancy Aruscavage, MS

Role: CONTACT

nancy.aruscavage@nurs.utah.edu

8015877353

Facility Contacts

Nancy Aruscavage

Role: primary

nancy.aruscavage@nurs.utah.edu

801-587-7353

References

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.

Reference Type: BACKGROUND

PMID: 28273753 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28990872 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31392286 (View on PubMed)

Clayton JL, Utz RL, Aruscavage N, Bybee SG, Bigger SE, Iacob E, Dassel KB. Using community engagement with FRAME: Framework for reporting adaptations and modifications to evidence-based interventions. Contemp Clin Trials Commun. 2024 Nov 26;42:101398. doi: 10.1016/j.conctc.2024.101398. eCollection 2024 Dec.

Reference Type: DERIVED

PMID: 39717518 (View on PubMed)

Other Identifiers

5R01AG069033-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GRANT13319762

Identifier Type: -

Identifier Source: org_study_id