Alzheimer DiseaseLEADNCT05909189
LEADing Dementia End-of-Life Planning Conversations
A study testing LEADing Dementia End-of-Life Planning Conversations in people with Alzheimer Disease and Mild Cognitive Impairment, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- LEADing Dementia End-of-Life Planning Conversations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has moderate to severe symptoms of dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah College of Nursing
Salt Lake City, Utah, 84112
About this study
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.
Read the 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
- Being tested
- LEADing Dementia End-of-Life Planning Conversations
- Keywords
- advance care planning, caregiving, decision-making
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| ADRD dyads | Experimental | This is a single-arm study enrolling 60 ADRD community-based dyads. Receives: Other: LEADing Dementia End-of-Life Planning Conversations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 20
Secondary outcomes (3)
Relationship Quality
Relationship quality as measured by both the care recipient and care partner as measured by the Dyadic Relationship Scale (DRS)
Measured: Week 20
Anxiety
Perceived symptoms of anxiety by both the care recipient and care partner as measured by the PROMIS Emotional Distress-Anxiety-Short Form 8a
Measured: Week 20
Subjective well-being
Perceived subjective well being of care recipient and care partner as measured by the PROMIS General Life Satisfaction- Short Form 5a
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start4 Aug 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kara Dassel, University of Utah
- Investigators
- Kara Dassel, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909189
- Sponsor's protocol ID
- GRANT13319762
- Other IDs
- 5R01AG069033-03
- Acronym
- LEAD
- Status last verified
- Jul 2026
- First submitted
- 12 May 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 28273753Supiano 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.
PubMed 28990872Dassel 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.
PubMed 31392286Clayton 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.
PubMed 39717518
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEADing Dementia End-of-Life Planning Conversations
- ClinicalTrials.gov ID
- NCT05909189
- Acronym / sponsor ID
- LEAD / GRANT13319762
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- advance care planning, caregiving, decision-making
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Aug 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ADRD dyads | Experimental | Other: LEADing Dementia End-of-Life Planning ConversationsThis is a single-arm study enrolling 60 ADRD community-based dyads. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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+
Key exclusion criteria (1 listed)
- Has moderate to severe symptoms of dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEADing Dementia End-of-Life Planning ConversationsThe 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. | Other | ADRD dyads |
Primary outcome
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
3 secondary outcomes
Relationship Quality
Time frame: Week 20
Anxiety
Time frame: Week 20
Subjective well-being
Time frame: Week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 28273753Dassel 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.
- Background: PubMed 28990872Supiano 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.
- Background: PubMed 31392286Dassel 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.
- Derived from this study: PubMed 39717518Clayton 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara Dassel, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEADing Dementia End-of-Life Planning Conversations in people with Alzheimer Disease and Mild Cognitive Impairment, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision-Making Self-Efficacy (time frame: Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05909189, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.