Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease (UPLIFT-AD)

October 21, 2025 updated by: Kathleen T. Unroe, Indiana University

The purpose of this study is to evaluate a comprehensive model for integrating both primary and specialty Palliative Care for older adults with dementia into nursing facilities. Palliative Care is a supportive care approach that aims to improve the quality of life of patients and their families facing serious or life-threatening illnesses, through the prevention and relief of suffering through the treatment of pain and other problems, using physical, psychosocial and spiritual approaches. Palliative care is specialized medical care for people who are living with a serious illness. This type of care is focused on providing relief from the symptoms and from the stress of the illness. The goal is to improve quality of life for both patient and family.

The UPLIFT-AD model will include providing education on primary Palliative Care for residents with dementia to nursing facility staff, training nursing facility staff in providing primary Palliative Care, and providing access to specialty Palliative Care consultations for residents. To help understand the impact of these interventions, this study will also collect information about resident health, the care they receive, and perceptions of their quality of life according to both family members and nursing facility staff.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this proposal is to evaluate the effectiveness of the UPLIFT-AD (Utilizing Palliative Leaders In Facilities to Transform care for Alzheimer's Disease) intervention and to assess the implementation context of the intervention using a hybrid 1 trial design. The UPLIFT-AD intervention includes 1) in-house PC champions trained to facilitate goals of care conversations with residents with Alzheimer's Disease and Related Dementias (ADRD) and their surrogate decision-makers, screen residents for symptoms and other PC needs, provide symptom management and serve as a liaison to external PC consultants; 2) specialty PC consultants who provide consults for complex residents and families; and 3) primary PC education for nursing home (NH) staff. The study will use a randomized, stepped wedge design involving 16 diverse NHs in Indiana and Maryland and 640 residents, 640 family members and/or surrogate decision-makers, and 320 nursing facility staff.

Study Type

Interventional

Enrollment (Actual)

1322

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
    • Indiana
      • Indianapolis, Indiana, United States, 46201
        • American Senior Communities

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-

NURSING HOME RESIDENTS:

  • Long-stay resident in an enrolled nursing home defined as not paying through Medicare Part A at the enrolled facility.
  • Has a diagnosis of moderate to severe ADRD, as measured on the Minimum Data Set (MDS)
  • Length of stay >30 days

FAMILY MEMBERS/SURROGATE DECISION MAKERS:

  • Family member and/or surrogate decision maker for an eligible resident in an enrolled nursing home
  • English-speaking

NURSING HOME STAFF:

  • Staff, nurse, or nurse assistant in an enrolled nursing facility
  • English-speaking

Exclusion Criteria:

-

NURSING HOME RESIDENTS:

• Short-stay resident, defined as paying through Medicare Part A at the enrolled facility and/or receiving respite care

FAMILY MEMBERS/SURROGATE DECISION MAKERS:

• Non-English-speaking

NURSING FACILITY STAFF:

• Non-English-speaking

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nursing Home-level UPLIFT-AD intervention
The UPLIFT-AD intervention consists of three major components delivered at the level of the nursing home: 1) in-house PC champions trained to a) facilitate advance care planning conversations with residents with Alzheimer's Disease and Related Dementias and their surrogate decision-makers, b) screen and follow up on residents' Palliative Care needs and c) serve as a liaison to Palliative Care consultants; 2) specialty Palliative Care consultant support providing individual consults for residents with complex Palliative Care needs; and 3) education on primary Palliative Care offered to all clinical NH staff.
Behavioral: UPLIFT-AD
Access to palliative care needs screening, advance care planning conversations, palliative care consultations
No Intervention: Usual Care
Usual nursing home care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in End-of-Life Dementia - Comfort Assessment In Dying scale (EOLD-CAD)
Time Frame: Baseline (prior to intervention) and12 months (post intervention implementation)
Nursing home staff and family members reported symptom frequency and intensity for 18 symptoms in the past 30 days. Symptom assessment was derived from the End-of-Life in Dementia Comfort Assessment in Dying (EOLD-CAD) and End-of-Life in Dementia Symptom Management (EOLD-SM) instruments. These symptoms included pain, discomfort, shortness of breath, choking, gurgling, difficulty swallowing, skin breakdown, restlessness, agitation, anxiety, depression, fear, crying, moaning, resistiveness to care, calm, serenity, peace. If the symptom did occur, respondents were asked if it had occurred once a month, 2-3 days a month, once a week, several days a week, or every day (ranging 0-5) and asked if the symptom was not at all intense, somewhat intense or very intense (ranging 1-3). Frequency and intensity were multiplied together for a score of 0-15 per symptom. A total score was derived by calculating the sum score and dividing by number of items. Higher scores indicate greater symptom burden.
Baseline (prior to intervention) and12 months (post intervention implementation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in End of Life Dementia - Satisfaction with Care (EOLD-SWC) scale
Time Frame: Baseline (prior to intervention) and 12 months (post intervention implementation)
The outcome measure is change in the EOLD-SWC scale score. Participating family members/surrogate decisionmakers provided answers to questions asked over a 30 day timeframe. There are 10 items, each measured on a 4-point Likert scale ranging from 1 to 4 as follows: strongly disagree, disagree, agree, strongly agree. The items are added together for a cumulative score for a range of 10-40, with higher scores indicating greater satisfaction with care. The questionnaire items address decision-making, communication with health care professionals, understanding the resident's condition, and the resident's medical and nursing care.
Baseline (prior to intervention) and 12 months (post intervention implementation)
Change in Quality-of-life (QOL)
Time Frame: Baseline (prior to intervention) and 12 months (post intervention implementation)
The outcome measure is change in the quality-of-life (QOL) measure scale score. Two quality-of-life questions were asked of nursing home staff and family/surrogate decisionmakers about the respective resident's quality of life. One quality-of-life measure is a seven point scale describing overall quality of life. Another is a five point scale describing quality of life. Lower scores indicate poorer quality of life.
Baseline (prior to intervention) and 12 months (post intervention implementation)
Change in staff palliative care knowledge
Time Frame: Baseline and 6 months (post intervention implementation)
Change in staff palliative care knowledge will be measured by the Palliative Care survey (PCS). The PCS is a validated instrument, which includes subscales evaluating the frequency of key PC practice behaviors: family communication, provider coordination, planning/intervention, and bereavement. The total instrument score and each of the subscales are averaged to produce a range from 1 to 4, with higher scores indicating superior PC practices.
Baseline and 6 months (post intervention implementation)
Quality of Dying in Long-Term Care (QOD-LTC)
Time Frame: Collected post-death
The quality of dying-long-term care (QOD-LTC) scale was developed for cognitively impaired and intact residents. It was developed to be reported post-death for residents in NHs and residential care/assisted living settings. It assesses perspectives on quality of personhood, closure, and preparatory tasks. Higher mean scores reflect a higher quality of end-of-life in LTC. This was collected from nursing home staff and family/surrogate decisionmakers.
Collected post-death
Change in Family Distress in Advanced Dementia Scale (Modified)
Time Frame: Baseline (prior to intervention) and 12 months (post intervention implementation)
The Family Distress in Advanced Dementia Scale was developed for use with family members of nursing home residents with advanced dementia. Eighteen items from the scale were asked, consisting of three domains of distress: emotional distress, dementia preparedness, and nursing home relations . Higher scores indicate higher distress. Collected from family/surrogate decisionmakers only.
Baseline (prior to intervention) and 12 months (post intervention implementation)

Collaborators and Investigators

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

Sponsor

Indiana University

Collaborators

University of Maryland, Baltimore
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Kathleen T Unroe, MD, MHA, Indiana University
  • Principal Investigator: John Cagle, PhD, MSW, University of Maryland, Baltimore

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)

September 8, 2021

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Estimated)

October 23, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005967061
  • R01AG066922 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A de-identified dataset will be created for the purposes of sharing with qualified users, along with data content, format, and organization, will be stored at Indiana University and be available through the Co-PIs. Deidentified data will be available to qualified users who execute Data Use Agreements (DUAs) with the research team and NH partners.

IPD Sharing Time Frame

The final de-identified dataset will be available to qualified investigators who meet the above criteria upon the on-line publication date of the final results of the trial.

IPD Sharing Access Criteria

Individuals requesting access to the data must provide the following: (1) Executed DUAs with all NH partners; (2) documentation of Institutional Review Board approval; (3) a written commitment that the data will be used only for scholarly research purposes; (4) a written commitment that the user will not attempt to identify any individual patient or NH; (5) confirmation that the data will be secured using appropriate computer technology; and (6) a written commitment that data will be destroyed or returned after analyses are completed.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE
  • CSR

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.

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