LEADing Dementia End-of-Life Planning Conversations (LEAD)

July 8, 2026 updated by: Kara Dassel, University of Utah
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah College of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADRD dyads
This is a single-arm study enrolling 60 ADRD community-based dyads.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision-Making Self-Efficacy
Time Frame: Week 20
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship Quality
Time Frame: Week 20
Relationship quality as measured by both the care recipient and care partner as measured by the Dyadic Relationship Scale (DRS)
Week 20
Anxiety
Time Frame: Week 20
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
Subjective well-being
Time Frame: Week 20
Perceived subjective well being of care recipient and care partner as measured by the PROMIS General Life Satisfaction- Short Form 5a
Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Kara Dassel, PhD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRANT13319762
  • 5R01AG069033-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The data will become available upon completion of the study and once findings have been published by the study team.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe