NCT05909189

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
12mo left

Started Aug 2024

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Aug 2024May 2027

First Submitted

Initial submission to the registry

May 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 4, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

May 12, 2023

Last Update Submit

April 3, 2026

Conditions

Alzheimer DiseaseMild Cognitive Impairment

Keywords

advance care planningcaregivingdecision-making

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Relationship Quality

    Week 20

  • Anxiety

    Week 20

  • Subjective well-being

    Week 20

Study Arms (1)

ADRD dyads

EXPERIMENTAL

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

Other: LEADing Dementia End-of-Life Planning Conversations

Interventions

LEADing Dementia End-of-Life Planning ConversationsOTHER

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.

ADRD dyads

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Has moderate to severe symptoms of dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah College of Nursing

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 28273753BACKGROUND

  • 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.

    PMID: 28990872BACKGROUND

  • 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.

    PMID: 31392286BACKGROUND

  • 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.

    PMID: 39717518DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Kara Dassel, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kara Dassel, PhD

CONTACT

801-646-4667kara.dassel@nurs.utah.edu

Nancy Aruscavage, MS

CONTACT

8015877353nancy.aruscavage@nurs.utah.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The LEAD Intervention is a web-baed platform that integrates the LEAD Guide with self-paced educational modules that guide care recipient-care partner pairs through conversations and the process of dementia-focused advance care planning. The aims of this study are: 1. To describe the acceptability, usability, and feasibility of the LEAD Intervention. Methods: Conduct a process evaluation using survey-based outcome assessments and qualitative analysis of participant-recorded advance care planning conversation(s)to identify facilitators and/or barriers to intervention participation. 2. To assess the initial efficacy of the LEAD Intervention on the primary outcome and secondary outcomes as perceived by both the care recipient and the care partner. 3. To examine advance care planning congruence as a mechanism of action for the LEAD Intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Assistant Dean

Study Record Dates

First Submitted

May 12, 2023

First Posted

June 18, 2023

Study Start

August 4, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

We welcome analysis and use by other investigators once our primary aims have been analyzed and disseminated. All data and resources will be shared following the policies of the University of Utah and NIH. We will share LEAD intervention survey data by depositing these data at National Alzheimer's Coordinating Center (NACC), which is an NIH-funded repository. These data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes such as examining components of self-efficacy. Data will be shared in an Excel file format that will allow for easy access to qualified users. Shared data will include participant demographic information and survey data relevant to all predictor and primary study outcome variables.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data will become available upon completion of the study and once findings have been published by the study team.
Access Criteria
We will share LEAD intervention survey data by depositing these data at National Alzheimer's Coordinating Center (NACC), which is an NIH-funded repository.

Locations

US(1)