120 Participants Needed

End-of-Life Planning for Dementia

(LEAD Trial)

KD
NA
Overseen ByNancy Aruscavage, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Utah
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment LEADing Dementia End-of-Life Planning Conversations?

Research shows that structured conversations about end-of-life care with family members of people with advanced dementia can lead to higher satisfaction with care and more informed medical decisions. This suggests that having guided discussions, like those in the LEADing Dementia End-of-Life Planning Conversations, may help improve decision-making and satisfaction for families dealing with dementia.12345

Is the End-of-Life Planning for Dementia treatment safe for humans?

The research articles do not provide specific safety data for the End-of-Life Planning for Dementia treatment, but they discuss the importance of advance care planning in dementia, which is generally considered safe as it involves discussions and decision-making rather than medical interventions.56789

How is the LEADing Dementia End-of-Life Planning Conversations treatment different from other treatments for dementia?

The LEADing Dementia End-of-Life Planning Conversations treatment is unique because it focuses on facilitating structured conversations between family members and clinicians to plan end-of-life care for people with dementia, addressing the challenges of decision-making when the person can no longer make decisions themselves.310111213

What is the purpose of this trial?

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.

Research Team

KD

Kara Dassel, PhD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for pairs consisting of a person with early-stage or preclinical Alzheimer's/dementia and their care partner, who could be a spouse, long-term partner, or adult child. The person with dementia should have memory lapses or cognitive complaints but can still do daily tasks. They must recognize changes in their memory and thinking.

Inclusion Criteria

I am part of a care pair for someone with early-stage cognitive issues, and I am their spouse, partner, or adult child.
I am in the early stage of Alzheimer's as defined by the Alzheimer's Association.
I have noticed changes in my memory or thinking, or I've been told I have mild cognitive impairment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Refinement

Refinement of the LEAD Intervention based on pilot work (Stage 1A)

4 weeks

Intervention Evaluation

Evaluation of the usability, acceptability, feasibility, and initial efficacy of the LEAD Intervention (Stage 1B)

16 weeks
Multiple virtual sessions

Follow-up

Participants are monitored for outcomes related to decision-making self-efficacy, subjective well-being, anxiety, and relationship quality

4 weeks

Treatment Details

Interventions

  • LEADing Dementia End-of-Life Planning Conversations
Trial Overview The study tests the LEAD Intervention, a web-based platform designed to help those with early Alzheimer's/dementia discuss and document end-of-life preferences. It aims to empower them and their care partners to make informed decisions about future healthcare needs.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ADRD dyadsExperimental Treatment1 Intervention
This is a single-arm study enrolling 60 ADRD community-based dyads.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

In a study of 32 older adults with a mean age of 84.1, over half (53.1%) were found to lack the capacity to engage in advanced care planning (ACP), particularly struggling with understanding the concept of ACP.
The Advance Care Planning-Capacity Assessment Vignette tool (ACP-CAV) was accurate in assessing capacity in 68.8% of cases compared to the MacCAT-T, indicating that while it can be useful, clinicians should ensure thorough understanding and consider further assessment when needed.
Should capacity assessments be performed routinely prior to discussing advance care planning with older people?Kiriaev, O., Chacko, E., Jurgens, JD., et al.[2019]
A pilot intervention aimed at improving end-of-life care for patients with advanced dementia involved palliative care assessments and advance care planning (ACP) discussions, but only 7 out of 33 participating carers actually completed an ACP despite receiving support.
The study highlighted challenges in recruiting carers during acute hospital admissions and indicated that while the care planning discussions were positively received, there is a need to further investigate the barriers preventing carers from writing ACPs.
Palliative assessment and advance care planning in severe dementia: an exploratory randomized controlled trial of a complex intervention.Sampson, EL., Jones, L., Thuné-Boyle, IC., et al.[2021]
In a study involving 166 caregivers of individuals with dementia, goals of care conversations were linked to better outcomes in advance care planning, including the perceived usefulness and adherence to advance directives.
These conversations also increased the likelihood of decedents dying in their preferred location, highlighting the importance of facilitating discussions between caregivers and people with dementia for effective end-of-life planning.
Goals of Care Conversations and Subsequent Advance Care Planning Outcomes for People with Dementia.Ma, H., Kiekhofer, RE., Hooper, SM., et al.[2022]

References

Should capacity assessments be performed routinely prior to discussing advance care planning with older people? [2019]
Palliative assessment and advance care planning in severe dementia: an exploratory randomized controlled trial of a complex intervention. [2021]
Goals of Care Conversations and Subsequent Advance Care Planning Outcomes for People with Dementia. [2022]
Vital conversations with family in the nursing home: preparation for end-stage dementia care. [2014]
5.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
[The Impact of Family-Centered Advance Care Planning for Persons With Dementia and Family Caregivers on Decision-Making Conflicts in End-of-Life Care]. [2021]
The Dartmouth Dementia Directive: Experience with a Community-Based Workshop Pilot of a Novel Dementia-Specific Advance Directive. [2020]
Medication appropriateness for patients with dementia approaching the end of their life. [2018]
The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. [2022]
Initiating advance care planning on end-of-life issues in dementia: Ambiguity among UK and Dutch physicians. [2021]
Advance care plans in dementia: user-centred design. [2021]
Facilitated case conferences on end-of-life care for persons with advanced dementia-a qualitative study of interactions between long-term care clinicians and family members. [2022]
Advance care planning in dementia. [2017]
13.United Statespubmed.ncbi.nlm.nih.gov
Developing an applied model for making decisions towards the end of life about care for someone with dementia. [2021]
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